Skip to main content

tv   FDA Commissioner Top FDA Officials Testify on Baby Formula Shortage  CSPAN  May 26, 2022 6:05am-9:05am EDT

6:05 am
6:06 am
we take into this hearing on baby formula in the united states. >> members can participate in this hearing in person or via online videoconferencing. for the members participating remotely, your microphones will be put on mute to eliminate background knows that background noise. please note that once you on your microphone, anything said will be heard over the loudspeakers in the committee room and subject to be heard by the livestream and c-span.
6:07 am
because members are participating from different locations, all members' questions will be in order of seniority. all documents will be entered into the record at the conclusion of the hearing. the chair will now recognize herself for an opening statement . >> subcommittee seeks answers on how families across the country have faced empty shelves during this infant formula shortage. we expect answers from the fda, abbott, and the other two leading formula manufacturers on why caregivers are scrambling to find the necessary nutrition they need to sustain their babies and children. most importantly, we will discuss solutions to prevent this from ever happening again in the future. the current formula shortage has real consequences. babies and children are
6:08 am
suffering. parents are nervous wrecks trying to this. i have heard stories from partitions -- from pediatricians trying to get nourishment for their children. i have spoken to parents who have driven from store to store to find formula. i have heard from children's hospitals who are seeing an increase in patients because caregivers have not been able to secure the formula they need. we know this has a disk portion it -- a disproportionate impact on of income families and families that rely on special formulas for children with special needs. these are our top priorities in today's hearing. the tragic situation is unacceptable and was totally preventable. there were growing strains in the months leading up to
6:09 am
illness, but the recall itself turned the formula surprise into a tailspin. abbott is not blameless. the company appears to have neglected essential manufacturing and cleaning processes that are in place to guarantee the safety and reliability of products needed for our most vulnerable populations. today, the batch of contaminated infant formula that sickened four infants resulted in two of their deaths. the bacterial sample strain of the sample taken from two of the four infants was not found in environment of samples taken from abbott's production facility. alarmingly, the facility has too long of a record of deficiencies, including evidence of the same bacteria on site and batches of its formula in 2019 and leading up to the 2021
6:10 am
inspection. fortunately, some batches were caught. this presents a disturbing pattern of negligence. one company alone does not bear the entire burden for lending in this current situation. there are questions surrounding the timeline of fda's investigation response from a four-month lapse from returning to inspect the facility, delayed connection with a whistleblower, and slow communication to the american people. there is much more to learn about fda's actions. we see clarity on what the agency was doing behind the scenes during this critical time period and what lessons have been learned from the situation. i am pleased the fda and administration have been focused on solutions, announcing a range of actions across the federal government to increase formula for companies in the most
6:11 am
special need. as manufacturers are in the midst of these productions, maximizing productions to meet the urgency of the moment. we are also joined by the other two major manufacturers of infant formula in the u.s., gerber and reckitt. these companies have been ramping up production and bringing safe formula into the supply stream to fill gaps. the biden administration's efforts to coordinate this response to get families out of the immediate crisis have been extensive and i think we will see they are working soon. we cannot ignore the need for longer-term solutions. the bottom line is that the fda needs the resources to make sure the food part of food and drug administration is not an afterthought. just as fda works to ensure that
6:12 am
life-saving medicines are safe and effective, the agency must have resources and staffing to ensure the food consumers consume is safe and reliable. fda's food safety oversight is resourced at only half the amount of drugs and biologics. as a member of the subcommittee for decades, i will tell you this is not a new problem. it has been under resource for far too long. i am pleased that the house passed funding to address the current emergency. a one-time fix is not enough to build a more resilient safety for the future. we have to work together to bolster the supply chain system not just today but for our children tomorrow. the empty cells -- the empty shelves are inexcusable and the stories of caregivers scrambling to find nutrients their children want and need are heart-wrenching.
6:13 am
i stand with our colleagues and witnesses today in committing to find solutions, permanent solutions, with the american public. at this time, i am proud to recognize the ranking member, mr. griffith, for the opening statement. rep. griffith: thank you for holding this critically important hearing. i want to thank the commissioner personally for coming to this hearing and responding to a phone call the fda arranged. at the hearing last week, commissioner califf said he would be prepared to go into much more details today at our oversight hearing. i look forward to learning those details. many infants in the u.s. rely on formula for nutrition and parents are experiencing anxiety as the country faces an infant formula shortage. no parent should have to worry about how they're going to feed
6:14 am
their baby. i've heard from folks all over southwest virginia who are having issues providing the most basic need for their infants. the big question is why did the biden administration let shortage become so dire without acting with urgency? i anticipate we with your different excuses today and i'm not interested in debating whether babies can switch from one branch to another. i'm looking for answers and long-term plans moving forward so this doesn't happen again. how did we get here and when did this shortage begin? the fda says it has been on their radar since march 2020. hhs secretary said the committee has been keeping him aware of the situation since last year. when asked if moore could have been done sooner, white house press secretary said hindsight is always 20/20.
6:15 am
in response to criticism that the white house was too slow to respond, president biden told supporters if we had been better mind-readers, i guess we could have but we moved as quickly as the problem became apparent to us. so which is it? was the administration aware shortage was developing for over two years and failed to take action? or were they caught flat-footed? or as i believe, both. no matter the reason, it is not acceptable. suffice to say i have a lot of questions for our fda witnesses. with all of the stresses on infant formula, including disruptions in the supply chain and consumer stockpiling, the availability of formula on shelves was already strained before abbott closed their sturgis, michigan facility. where was the biden administration plan to deal with
6:16 am
what should have been a foreseeable event? we did not see a plan on february 17 or 18th or march 1 or even in april. in fact, the fda did not conclude its follow-up inspection until march 18. it was not apparent until mid-may that the right and administration took this seriously and began to act. why did it take any onslaught of national media attention for the biden administration to act with agency -- urgency required to address an infant formula shortage? abbott submitted their response following the inspection on april 8. not until may 16 did the fda working with the department of justice issue a consent decree. i don't understand how the fda can justify three-months to respond to this crisis. i expect to learn why the fda did not move heaven and earth in an attempt to get the sturgis
6:17 am
plant back up and running as soon as possible. folks, february to june is not acceptable to the american families and american parents don't consider that working as soon as possible. i also have questions for the infant formula manufacturers because they have a role in this crisis as well, including what can be done to increase supply and what will be done to prevent something like this from ever happening again. i have questions for abbott about the events that led to be shutting down of the sturgis plant. i hope to hear about the status of the plant and abbott's efforts to reopen the plant. being a parent rings an incredible amount of joy -- brings an incredible amount of joy, excitement, and love. but it can also be an incredibly frightening time for parents. parents should not worry about
6:18 am
how or if they will feed their baby. the ability to provide nutrition for a young infant cannot be ignored. more must be done to prevent future shortages. statements like if we had been better mind-readers, we could have acted more quickly, those do not inspire confidence. the american people deserve answers. i look forward to discovering how to address this ongoing crisis. i thank they witnesses for being here and being part of this discussion. ideal back. rep. degette: the china recognizes the chairman of the -- committee for five minutes. >> thank you for organizing this hearing quickly. today, parents and caregivers
6:19 am
are seeing empty store shelves, astronomical prices online, or having to drive hours for the formula they need to feed their children. this hearing will understand -- will seek to understand how this occurred, how to address it, and how we can prevent it from happening again. our solutions will include the distillation -- include legislation and -- the data on the extent of the shortage based on where a family lives or whether a child needs a specialty formula or a specific type or brand, so some regions have been hit harder than others. disturbingly, low income women and children who rely on the wic program have been particularly impacted. the shortage begin to rise after strains on the supply chain. there's no question --
6:20 am
the impact from just one infant formula plant closing in the u.s. shows the power one single manufacturer has two influence the nation's supply of formula when three companies control 95% of the market. we are too reliant on too few companies to do the right thing. when one company cuts corners, we spiraled into emergency. there needs to be more competition so these manufacturers don't have a monopoly. this committee will examine the circumstances surrounding the recall and shutdown. we will all go -- we will also ask about the sturgis facility and the timeline of actions to address safety risks. we also have to address the current shortages and address future supply strains about the
6:21 am
supply shortages they face and the challenges and steps they take to increase the availability of safe infant formula. the fda officials and executives need to answer some tough questions. abie's lives are at stake and they american people demand answers and solutions. fortunately, the biden administration has taken responsive action to increase the supply of formula for american families. it worked with manufacturers to increase production and encouraged importation of safe infant formula. the president also launched operations to increase to mystic reduction and bring safe imported formula to store shelves. the fda has also eased import restrictions for hundred 80 days to allow international manufacturers to help address the shortage while ensuring formula meets our national safe and nutrition standards. congress has already taken swift
6:22 am
action, too legislation which the president signed on saturday into law which grants flexibility to the wic program to increase the supply of formula available to families. the house passed the infant formula appropriation act providing the fda with resources to resolve the current baby formula shortage and lay the foundation to make sure this never happens again. we have to do more. fda's food safety efforts have been underfunded, under resourced, and understaffed. this committee took a step to address that by advancing an fda bill that will strengthen its ability to recruit and retain highly qualified staff across the agency, including areas overseeing baby formula and baby food. that bill will head to the floor in coming weeks. additional legislation will be necessary to improve transparency and requirements and empower the fda to set limits more on contamination. they must do as part to ensure
6:23 am
robust controls being followed to prevent contamination products from reaching a single child. put simply, it should not take the direct intervention of the fda and the president to keep infant formula on the shelf. the manufacturers have to take responsibility. we must all work together to guarantee the safety and supply of baby formula to ensure the health of our nation's children. the energy and commerce committee will act as always, on a bipartisan basis, to enact necessary legislation. this committee hearing is important. it will lay the groundwork for what we have to do legislatively. i want to besides that. thank you, madam chair. thank you for doing so many things of an oversight nature with this subcommittee. i yield back. rep. degette: the chair is pleased to recognize the ranking member of the -- committee for
6:24 am
five minutes. >> before i begin, i want to address the school shooting in texas. this morning, i took my kids off to school and i never thought about the possibility about it being the last time i would see them. school is about making friends and being kids. i know you're anxious to get the information, we want answers of what would put someone in a place to take young innocent lives. there is a sense people are struggling, crime and violence is going up. there is a mental health crisis. these are the conversations we must have together and i hope that we will to help end this despair and bring hope to our communities again. regarding today's hearing and the point i baby formula shortages, parents should not have to drive hours paying record high gas prices, visiting multiple stores to find formula
6:25 am
after midnight to finally see their children two or three days more. that is the reality of the crisis in america today, putting newborns and babies in the hospital. there are parents are unsure if they will be able to feed their baby. they need support and meaningful action to increase supply. they also demand answers. including the failure by fda and the administration not acting soon enough. the biden administration said it did not anticipate the formula shortage. it should have as part of the pandemic response, ft had a data and analytics tool to monitor the supply chains of race products, including infant formula. the food city center was in contact with the infant formula
6:26 am
industry to monitor ingredients and other components for production and maintain a healthy and safe supply. a january wall street article, a month before the abbott plant closed -- found to recall formula. they just had to read their own data and listen to parents. with abbott being a major supplier and given the information at its disposal, the fda should have known the plant closure would have made the shortage even worse. this is not the first time fda has been confronted with looming supply crisis. in 2004, the flu vaccine supply was provided by only two manufacturers. one, a british company, shutdown after fda inspectors found safety problems. that meant just before the flu
6:27 am
season half of the u.s. flu supply -- flu vaccine supply was gone. the administration medially took action to secure doses of other manufacturers and encourage manufacturers to seek licensure from the fda. when abbott's plant closed, the biden administration should have acted with urgency to increase supply on day one. the fda did not act decisively until parents forced them to move publicly. the fda failed to respond properly to the warning signs. in september 2021, fda conducted an inspection and issued a report that found hazardous food safety practices. around the same time, fda received four complaints about infections in infants. two of the babies died.
6:28 am
all have been reportedly consumed abbott nutrition product though a link has yet to be established. in october 20 21, the fda received a complaint about the sturgis plant from an ex employee who alleged data falsification and release of untested products. there was a life and death crisis in front of fda but they failed to see the severity of these situations. the fda did not interview the whistleblower until months later and did not inspect the plant until january 2022. fda did not even form an incident management group on infant formula until april 1, 2022, more than six months after it found issues. this hearing is any opportunity to assure parents are certain the fda does not repeat mistakes that led to these shortages. i am leaning on legislation to increase and restock empty shelves. it also requires more oversight and accountability to ensure the
6:29 am
fda is doing his job at acting quickly. we must solve the issue and making sure we are taking actions so this situation never happens again. i thank you and you'll back -- and yield back. rep. degette: the chair asks unanimous consent that opening statements be made part of the record and without objection so ordered. i want to introduce our first panel of witnesses. dr. robert califf, the administrator of the food and drug administration. the deputy commissioner for food policy and responsiveness, and dr. susan may, the director of the center of food safety and applied administration -- and applied nutrition of the fda. i know you are aware the committee is holding an investigative hearing and when we do so we have the practice of taking our testimony under oath. does any of you have any objection to testifying under oath?
6:30 am
>> no objection. rep. degette: let the record reflect that the witness responded no. under the rules of the committee, you are entitled to be accompanied by counsel. do any of you wish to be accompanied by counsel. >> no. rep. degette: witnesses have responded no. please raise your right hand so you may be sworn in. do you swear that the testimony you are about to give is the truth, the cold truth, and nothing to the truth -- nothing but the truth? >> yes. rep. degette: they witnesses have responded affirmatively and you are not under oath and subject of penalty set forth in the u.s. code. the chair is pleased to recognize commissioner caleb -- commissioner robert califf for 10 minute opening statement on behalf of all of our fda witnesses. i want to note there is a timer on the screen, you can see it,
6:31 am
that counts down your remaining time. i want to thank you for appearing and recognize you for 10 minutes. mr. califf: thank you madam chairwoman. thank you for inviting us to testify. and she -- ensuring that infant formula is safe and nutritious is a important job of the food. we are fully aware that many parents and caregivers have been unable to access the formula product they need. many of us are parents and grandparents, too, and we want to express our super before parents and caregivers experiencing difficulty and stress as they attempt to find formula. i have been driven by memories of the month my daughter spent in the intensive care unit as an
6:32 am
infant and the deep concern and anxiety of a parent to protect any innocent child. we have provided you with a written testimony describes the history of the problem and gives a detailed timeline during this hearing, i welcome reference to this document. on september 20, 2021, fda learned of an infection in an infant who consumed formula produced at abbott's nutrition -- abbott nutrition's facility. the timeline specify the chain of events, and ate it in a four because on-site inspection of the sturgis facility on january 31, 2022. while there are many stops along the way for different actions, to this date i can find no evidence of intentional delay or malfeasance. we have the facts delineated at this point.
6:33 am
after action review, improvements to prevent delays like this in the future and to improve our decision-making. i've asked dr. steven solomon, director of our center of veterinary medicine, to lead this review. before leaving the center, he served in the office of regulatory affairs and has organizational knowledge of the food program as well as compliance and enforcement. the fda and cdc investigations cannot conclude that the unsanitary conditions in the abbott facility caused the illnesses reported. however, we cannot rule it out. the consequence of events is unusual. there is no dispute that the facility was unsanitary. the results were shocking. standing water, cracks and achy equipment that presents the potential for bacteria infection
6:34 am
to exist, particularly in the presence of moisture, leaks in the roof, inadequate handwashing, and -- sent tatian. bacteria growing for multiple sites and a disappointing lack of attention to the culture of safety in this product that is so essential to the lives of our most precious people. as a clinician, i have used life-saving drugs and diagnostic tests and cardiovascular devices made by abbott. this is so far removed from our previous experience with the company that i am very concerned as soon as we received positive results from environmental samples we collected during the inspection, we contacted abbott to issue a voluntary recall. they need to protect the most vulnerable of all of our infants presented a dilemma. this is the largest manufacturer and the sole source of metabolic
6:35 am
formulas essential for the viability of infants. with no substitution possible, because abbott had no backup plan. we knew that seizing operations would create supply problems but we had no choice given the unsanitary conditions. we took several critical steps within hours, including reaching with those who had been dealing with our supply chain throughout the pandemic. in memo was sent to agencies showing the risk. products were made available on a case-by-case basis, consulting with pediatricians and safety experts. -- increasing production to supply the market. we asked retailers to place limits on how much anyone person could buy to minimize access buying. we remain infrequent education -- medication with our partners about the status and risk.
6:36 am
because of the diversification of this market and the lack of a central hub, we concluded getting the sturgis facility running was a top priority. we had no confidence in the integrity of the abbott quality program. we initiated proceedings towards a consent which allows abbott to ensure safe production on formula, including hiring an outside expert. our oversight is critical, but make no mistake, the return from normal will only occur when abbott resumes production in a safe manner. as details in charts included in the testimony, -- the stocking of formula and the rate of consumption along. sales of infant formula have remained steady and in fact volume and quantity of formula purchased our 5% to 50% higher
6:37 am
now than in the months -- 52 -- 5% to 15% higher than in months before the recall. we knew that distribution was an issue. some areas where excreting shortages, but overall there was enough formula to go around. about one month ago, the reports of shortages proliferated. there was not a drop in production. this increase presents heightened concern for parents and caregivers about shortages leading to an understandable effort to ensure etiquette supply at home. this cycle has happened with other products throughout the pandemic. we realize the only solution is to have adequate supply to make sure shelves are stocked. to that end, we have employed measures to increase supply. including an agreement that will allow sturgis plant to get back
6:38 am
in production mode. i met with the abbott ceo and he assured me they will be ready to go in early june. we continue to work with manufacturers to increase production and distribution. i commend them for their efforts and we have seen substantial increases. we are helping with the all of government response and support importation of products not currently in the u.s. market by using case-by-case easing of regulatory requirements to increase the number of many factors allowed to import formula. working with state health commissioners to increase availability of wic and issue additional suppliers to enter the market and eliminate price counters. -- price gougers.
6:39 am
we have worked to manage the complex issues encountered by those with infants with metabolic issues requiring special formula. i will leave you with several thoughts. fda's timeliness of interviewing the whistleblower and getting into the facility for a four because inspection were too slow and some decisions could have been more optimal. i did not return to fda to preside over business as usual. as many of you know, i was enjoying a good life in the abbott sector when asked -- in the private sector when asked to come back. i believe that success follows proper attention to structure and function, leadership and resources to support the work of employees. all of these issues need attention in the underfunded side of the fda. you will see changes in the near future. our request for funding and authority are essential in concert with improved operations and leadership. the return of the sturgis plant
6:40 am
to safe production of formula is critical. abbott's marketshare share left it with responsibility to produce safe infant formula that was not met. we will do everything to work with abbott to make this happen as quickly as possible. this time it -- this timing is in abbott's control. companies inside and outside of the u.s. has been heartening. while we wait for abbott to fulfill its responsibility -- [no audio] from a variety of sources. this did not happen overnight. across the industry we regulate, we are singing of just-in-time distribution system, market contribution of contracting leading to shortages. multiple calls for supply chain management until regulatory agencies have access to supply chain information and personnel
6:41 am
to do the work, we will continue to react to supply chain reactions -- supply chain disruptions. we will not rest until our shelves are replete with safe and nutritious infant formula and i will work with the fda to promote the health and well-being of the american people, particularly our most vulnerable people. rep. degette: thank you so much, commissioner caleb. -- commissioner robert califf. i appreciate your commitment to try to fix it. i want to make sure we are on the same page and i want to go through the timeline presented in your written testimony. you referred to it, too. from september 20 through the 24th in 2021, fda did a routine inspection of the sturgis facility. coincidentally on the same date,
6:42 am
september 20, fda got news about an infant who had become ill due to the bacteria after consuming infant formula reduced at sturgis facility. about a month later, fda got a complaint from a whistleblower about the lack of cleaning and testing facilities at sturgis as well as alleged falsification of records and deception of fda inspectors. that person was not interviewed until two months later in december. between december and february 2022, fda received three more consumer plan -- consumer complaints, two that resulted in death. despite all of this, fda did not return to inspect the sturgis facility until january 31. according to your testimony, there was a six-week inspection and there were fundamental
6:43 am
sanitation and equipment issues. but then february, abbott closed down the plant at sturgis and ceased production. two days later, finally abbott voluntarily recalled the products. on march 18, fda closed inspection and issued its inspection observations to abbott. finally on may 16, fda and abbott consent decree reviving steps abbott needs to undertake. that was may 16. now abbott is telling me it will take two weeks to clean the plant and then take up to six to eight weeks to get back to full production. commissioner, this is what i am concerned about. i went through this timeline. by my count, it took about four months from when the agency first became aware of these reported cases to inspect the
6:44 am
sturgis plant and then it took two more weeks for abbott to stop production and then took three months more for fda and abbott to enter into a consent decree. does that sound about right? mr. califf: that sounds right. it is all documented in your testimony. rep. degette: what all of us are concerned about, obviously, and the parents of america are concerned about, it could be up to a year between the first inspection in september last year and full production at this point. at the same time, the vulnerable infants and children are not getting their formula. i guess you refer to this that you have somebody looking into it. do you have any idea why it took so long from the report to inspection and recall? what is
6:45 am
the plan to shorten the time in the future? mr. califf: you are right to be concerned and the public should be concerned. it was too slow and there were decisions that were sub optimal along the way. i'm sure you also know that as i was going through confirmation i got many calls from people concerned about the food because of the lack of resources and concerns about the organizational struck -- organizational structure. my plan has been to get to this crisis and then we will look at the food program on the perspective of reforming but not ready to deal with the specifics of this case. this is where dr. solomon who is a truth teller will lead an effort to a bus get the processes.
6:46 am
rep. degette: i have been on the subcommittee for several decades and the food program of the fda -- we had the peanut butter crisis, we had many crises. we rushed to make that plant safe and clean it up. ultimately, we have to work together to put food back into food and drug administration. we have to not just throw money at it, we have to figure out what to do to make these inspections robust and shorten the time. would you agree with that? mr. califf: i would agree with that and applied what you did on the mechanical side. the food side it's a shot in the arm. rep. degette: we will work on it.
6:47 am
thank you so much, i am pleased to recognize the ranking member mr. griffith for five minutes. rep. griffith: thank you so much. dr. califf, thank you for being here. i respect you for coming up to answer the tough questions. i know it is not what you intended but some could take the impression that in part you are the new moms and dads who were scared their children cannot be fed and they were over buying. the answer is not that moms and dads are responsible, it is the manufacturers. i think that is important. let me go to some follow-up questions. according to your written testimony, it was december 6 when you're team finally got
6:48 am
together and the fta team got together to say we ought to have a plan to inspect the sturgis plant. the timeline attached to your written testimony says that the first time they got together they got together was october 21. when you have a problem identified in september, i am glad you have already agreed that getting to do an inspection january 31 is too late. you agree that is too slow, yes or no? dr. califf: yes. rep. griffith: i'm curious that your testimony said the fta first had concerns about formula
6:49 am
production in march 2020. the situation was going to get worse with the facility -- the abbott facility which makes a large percentage of -- did the fda have an action plan to deal with one of the manufacturers shutting down and what were going to do when the kids did not have enough formula? did we have a plan on what action we would take? dr. califf: we had several committees doing things i mentioned which was contracting -- which is contacting the other members -- the other producers. they did ramp up to the extent that they could. rep. griffith: the question is, when you have one source in most
6:50 am
states they can purchase, and a lot of times that is abbott, why did it take three months to say we are going to have a relaxation on some of these regulations when it comes to wick, a relaxation on some of these products coming from europe. where was the request for -- from us? where was the request to start flying in formula overseas? why was that not happening in march instead of mid day -- mid-may? dr. califf: can i refer to other colleagues or can answer the question? rep. degette: they can refer to them if they have the answer. dr. califf: we were monitoring this and the system seems to be keeping up with demand until
6:51 am
there were shortages we were responding to. at the same time, we were trying to get the abbott plant up as quickly as we could. mr. yiannis may have an answer. rep. griffith: let me move to another question. i know you said you tried to get the plan up as soon as possible and i know you believe that. when you have an emergency situation like this, and i know you did some special things for the metabolic and kids who need special formulas, you tried to move on that quicker. when you have 11% to 12% of your total production going down, i wonder why it is taking so long to get where we are. why were we not working at breakneck speed? in the battle of midway, after being damaged at sea, general
6:52 am
everett says we need to get this ship out. that ship was sailing in two days because the american soldier got in there and got it done. i don't think you could get sturgis open in two days but why would it take four or five months to get it open? wiring -- why were we not moving in march and getting the plant open then? rep. degette: you can answer briefly if you would like. dr. califf: with regard to the sturgis plant specifically, as i say, we did not have confidence they would produce safe formula until he got control of the plant through the consent decree. the consent decree is a legal agreement involving the department of justice and the manufacturer that has to be negotiated.
6:53 am
i will also add, abbott started mediating the plan but it was so bad -- we met with them yesterday and there were some these steps in this sense -- even though they were working at since day one. they are still not ready to go but they will be in the next few weeks. rep. degette: the chair now recognizes chair powell loan -- chair pallone. rep. pallone: i want to talk about the current crisis. particularly legislatively since we are the organizing committee. i love the ranking member's war mentality because that is how this has to be right now, like a general in the field. the president has invoked the defense production act. you are taking actions with abbott. how is this going to couple at each other? will it be effective in getting
6:54 am
this formula out quickly? you're talking two weeks, three weeks, whatever to get this shortage over with. as part of that, how would you get information distributed so we can tell our constituents how they get this formula, how they have access to it? two minutes. dr. califf: this is a war mentality, a crisis we are fully aware of. families should not be searching from her love but they have to do it now until we fill in. several weeks out, we will have a surplus of formula. i can say exactly how many weeks. until then, we have to fill in with these measures. other producers have stepped up and we are now importing and flying military planes and other planes to pick it up and bring it in. we just have to keep filling in until we get to the point production is up.
6:55 am
rep. pallone: how about getting it out so that our constituents know how to get it? i am concerned you do all of this and they will not know how to access it and still have a problem, particularly low income people who don't have access to information. dr. califf: it is important for people to go to the hhs website, you will have helpful information about where to go. the distribution is be handling by professionals in the supply chain who have been working throughout the pandemic. as soon as it comes in, we will get it to the places that are in the greatest need. you are right, the public is going to have to stay attuned, hopefully through that website, to get information they need. rep. pallone: think of other ways because not everybody has -- let's think of other ways to
6:56 am
get that information out. my second question, with the authorizing committee, i am concerned about a future crisis because we need to have a mechanism where the manufacturers tell us or it triggers an alarm bell for the fda if they are experiencing shortages for whatever reason. what i'm told is maybe we need some transparent legislation through reporting requirements that would require many to alert fda of shortages so they can shift production or we can go into overload. also, something to empower the fda to act more quickly in regards to contamination. that process is so bogged down and regulatory -- bogged down in regulatory ways. what can we do to have better reporting?
6:57 am
what can we do so you don't get logged down in this long process whether it is potential contamination or any other tools you need? dr. califf: we have asked for a number of authorities and consistently -- just to remind the group of the -- of what is in the document. we requested authorities to deal with specifically infant formula shortages and we were not successful getting those acted upon. we did a number of things to try to deal with the resources we cobbled together. you mentioned things that are critical. right now, we have no ability -- there is no requirement manufacturers alert us if they are running short. secondly, for example, abbott had cultured bacteria in samples going back a ways, but since they not ship them out, they had
6:58 am
no requirement to keep the samples were alert us. we discovered it on inspection. it may surprise people to know that. the consent decree process we can have a long discussion about. for me, or to google for five years before coming back. you would be surprised to know there is a system where all the fda's -- there is no system where all of the fda employees can see what is going on. we need access to the information any fractures have about each of their individual supply chains. they each have their individual supply chains but there is no system to make sure the supplies are getting where they need to go. right now, we have a shortage of contrast -- we have to do something about
6:59 am
the supply chain. >> want to pick up where the chairman left. as a part of the pandemic response, the fda did not have the data tool to monitor the supply chain for various products, including infant formula? dr. califf: we requested funding for a tool and because we did not get the funding, we cobbled it together. it is a start but nowhere near. i was at google for five years. the technology at fda and many federal agencies is outmoded. >> i would like to understand more about that. as part of a pandemic response
7:00 am
congress authorized funding, various products including infant formula, fda food safety and contract with the industry to monitor ingredients and other components, i with a healthy and safe supply. the slow response to the infant formula crisis for parents. and two others are critically ill. on top of that, with the abbott plant shutdown and a possible safety problem it is presenting another public health crisis, the lack of access to baby formula. we learned there are four babies hospitalized because of complications from baby
7:01 am
shortage -- baby formula shortage. an additional public health crisis because people cannot get baby formula. how many reports of babies who got sick or worse, related to the shortage of baby formula? >> let me give a general answer, not a large number but how significant, we have a committee of people looking at every case to make sure we get formula for those people. doctor may spent countless hours looking with experts on this issue. >> one thing i would like to point out, we've been in discussion with formula manufacturers throughout covid. the discussion is not the same as data, we don't have the authority to mandate from the companies, to get necessarily all the information you would want to have to monitor the supply chains as indicated. >> i'm going to run out of
7:02 am
time. i want to know more about the data analytics tools congress authorized to help with this specific situation. did fda conduct an assessment of the public health impact of a baby formula shortage at the abbott plant having closed and what were the findings. >> what i would say, i was not here when that decision was made so i don't know all the details so i will refer to susan mayne but based on everything i looked at there was intense discussion about consequences of this and memos adamantly document into it. we simply cannot allow plant that was unsafe to be shipping. comment quickly. >> we anticipated this would have significant impact in the general formula but more so medical products and that is
7:03 am
why we made the decisions not to have those products be recalled because the concerns for the health of these infants were greater. with regard to the general infant formula supply what we heard from other manufacturers, the capacity to increase production, they have stepped up, they have increased production and that was the scenario planning and invoked mitigation steps like mitigation to reduce regulatory flexibility, things like asking the retailers to limit purchases, we did a number of steps from the get go to try to reduce the impact but we are in a tough place, we did not want to allow this unsafe formula prepared under unsanitary conditions to be served. >> i appreciate that. i feel i am getting on one hand we are being told the abbott plant is going to be up and
7:04 am
running in a couple of weeks. you testified last week concerning the whistleblower complaint that the integrity of the organization was compromised, on one hand how do you believe organizational integrity can be resorted in two weeks for the expected reopening of the plant if there are significant concerns. >> 30 seconds or so, the only way -- in my previous life as a doctor, it has been a great company but given what we saw the only way to have confidence is where you literally have oversight of every single step. when we met with the ceo yesterday there were hundreds of steps they went through that they are having to do many of which have already been done. it is only if we have direct
7:05 am
oversight that i would have confidence but i do have confidence that we are seeing every single step physically in person and through following the documentation and outside experts so -- >> the gentlelady's time has expired, chair will go to miss price - miss rice for 5 minutes, you are recognized. >> thank you, madam chairwoman. i think we have to dig a little deeper on how we can avoid the current bad situation in the future. we have to understand the missed opportunity for the formula recall, and apply those lessons going forward. when you think after the pandemic and that we didn't have enough, would have enabled us to look at these critical
7:06 am
products every day americans need just to survive and make sure this wouldn't happen. it is clear to me the delay between the fda's annual inspection of the sturgis plant in september of 2,020 one at fda inspectors return in late january 2022 four months later as the chairwoman pointed out after three reported illnesses was missed opportunity to say the least. understanding you are not yet in the position you are in now at that time but as far from the agency today, what steps have you taken to ensure we are not going to see god for bid something like this in the future where will take four months after notification before the fda initiates an investigation into whether it is abbott facility or any other facility. >> there are a number of steps,
7:07 am
the most important one is the escalation requirement that is notifying the leaders, documented in our report ahead of our office of regulatory affairs, were not notified until february that all this was going on and we have to have standards. i used to work in hospital quality. remember when medical errors, nurses were empowered when a surgeon made a mistake to report it. not as a punitive matter, we are putting systems like that in place but i must tell you that we still have vulnerabilities, we have a very tired, overworked workforce in the midst of a pandemic which is still ongoing, and underfunded segment.
7:08 am
when i worked in the best of facilities it is different than when you have really good people who could do other things for a living i can point out who are really straining to do things computers could do automatically. that is a list of some of the things. >> according to fda testimony, becoming aware of the first infant illness, the agency immediately notified abbott. my understanding that the fda inspectors who are on site conducting a routine inspection of abbott sturgis plant on september 20th through the 20 fourth were not told about the reported complaint of illness at the time of the infection. if that is accurate why were they not informed of the complaint and you believe more timely to munication about the illness could have better informed their assessment and
7:09 am
facility classification? >> two things to note, once the agency receives a complaint like this we have to follow up and every one of these complaints was followed up on, that means trying to obtain for medical information, that process takes time. product was obtained, it underwent microbiological testing. final testing results were not available, it does take time to get this resolved. had we known there been a complaint we wouldn't have known about that complaint at all, how that could impact the inspection, what they need to look forward to. in the real world, all that information, that is not what happens. i will reiterate, every one of these complaints the fda follows up with those procedures to follow up, get as much information about the complaint, that is could call to inform what you might look
7:10 am
for. >> my time is about to expire but the fact that there's three companies into manufacturers, and essential product we need to keep children alive we should look at increasing domestic production on that front. thank you, i want to thank the witnesses and yelled back the balance of my time. >> mr. burgess, you recognize for five minutes. you need to go on camera. i guess i'm going to go to mr. mckinley, you are our cameraman, i will recognize you for five minutes. >> thank you, madam chairman. thank you for holding this hearing because this is -- the abbott plant is one example of what happens when government agencies and private sector companies do not confront and disclose safety issues that impact public health. there was a twitter account
7:11 am
this week, a tv producer put on social media that there were multiple inspections showed no issues at the abbott plant, the fda bill passed last week was unnecessary. this statement was sent out last week across the country, documentation of these violations were reported during the last several fda inspections, firmly established there were serious problems at the plant that led to a recall and a plant closing. this escalated into a public health crisis yet both of the fda and abbott company have remained curiously silent. i remind you this statement that was put out on twitter and social media was sent last week saying of the government was wrong, there were no problems there. there are consequences, when
7:12 am
this type of misinformation is not rebutted. the public continues to lose confidence in the governmental process and we in congress did not hear about the scope of this issue until early may and the administration seems to be caught off guard. a couple questions. why did you not, maybe you have answered this but i want to hear it again. why did you not inform the public in january or february about the problems at the abbott plant? >> with all due respect, we did. by abbott and the fda about the problem with the product and the general reason it needs to be recalled. i have to point out in the midst of a consent decree negotiation it is difficult to
7:13 am
talk about specifics until it was completed because legal prohibition. >> a couple other questions. what are you doing to combat this type of social media providing incorrect public health information. how would you respond to that? >> i'm smiling because it is so critical right now that we get the misinformation situation under control. i worked at google for five years so i saw have a good and the bad of access to information. fda has to change its outward facing strategy to more proactive and preemptive. i would point to the american strategy with russia and ukraine as one of the best examples in history of always being one day ahead of misinformation.
7:14 am
>> two more, how will the passage of last week's fda bill increase production of baby formula. >> increasing -- >> they set on these -- it was not just one but several, it was unnecessary. i want to know how we get back to production, putting $28 million, how will that increase production? >> the abbott plant needs to get up and running. we need micro detail to make sure it is done correctly and as we bring in supplies from other countries, we already have overseas plants we import from on a regular basis, almost double digit so as we bring that product in we've got to inspected and make sure does the quality we expect of american formula and upgrade our information systems to make sure as all this goes on we can
7:15 am
keep track of it and make sure we are coordinated. >> did the fda have a mitigation plan in place before the plant was shut down? >> yes. doctor main -- susan mayne recounted in some detail keeping production up and it did increase on a national basis but the purchasing obviously outstripped the production as you well know. >> madam chairman, my time is expired. thank you and i yield back. >> i think the gentleman. >> i was going to begin by saying i am extremely concerned, a lot of talk about concerns but it is more than that. i'm pretty furious about the fda's lack of safety
7:16 am
leadership, communication and action and i also want to ask unanimous consent by putting into the record an "in depth" report done by politico called the fda food failures based on 50 interviews that really goes into detail that was done in april 2022 and i ask unanimous consent. >> if the gentle lady will submitted to committee staff we will do all of those unanimous consent requests at the end of the hearing. >> thank you very much. >> food safety over the decades, this is not a new story. it has been a real problem. i've been following this throughout my career and even before i became part of the
7:17 am
house of representatives and there's kind of an ongoing joke, not really a joke that i have heard that says, it is said by fda employees that says that the f in fda is silent lose we have not seen this as being the priority in the food and drug administration and now here we are. i can't tolerate any excuses and delays. i have just one question about timing although i think my colleagues have done a great job in talking about the various delays that there were. so according to fda testimony staff received the whistleblower report in
7:18 am
october 2021 and senior food staff officials did not respond to that report until four months later in february, how does that happen? how can that possibly happen? as i want to ask that of the administrator. can you hear me? hello? >> i got muted there. first of all, let me point out the complaint was received, it was logged in right away, the oh are a employees did their usual review. it went to oci, there were
7:19 am
concerns, the decision was made that the informant needed to be questioned and brought in to go over things, there were some issues that delayed it. i can't go into details because they are personal related, to that. we are on record saying that. on top of that as i already said. the lack of escalation that senior officials were not aware until february 20th or february 9th. >> so much has been said today that needs to change the focus. i know you are new to this position but you have a long history with the food and drug administration on the food side so we really are calling you to change the focus, the emphasis, to really put food on top. we are tired of one after
7:20 am
another of these kinds of situations. i also wanted to alert you i have introduced legislation that deals with chemicals that are in our food that are toxic, they are known toxic chemicals. i have legislation that would require research and removal of those from our foods. i hope you will consider that. don't want to hear anymore about this without prompt, swift response on the food and drug administration. back into the food and drug administration. i yield back. >> the chair's audio is down. we will hear from doctor burgess. i don't see doctor burgess. are you on?
7:21 am
i will go to mr. long. >> thank you, mr. chairman. i will have you rate performance of the fda in the situation. how would you rate the performance? >> i give it at best 4 or 5. >> i would like to have you rate the urgency of what the agency it with no baby formula on the shelves. within the administration from one to 10. >> 9.5, nights, weekends, i would stand behind the efforts.
7:22 am
i cannot give it a high rating. >> you've got to show me, 9, 10, it has failed so how do you account for that? >> the people working on the ground are working their tails off, speaking of being from missouri, working as hard as they can with inadequate systems, inadequate funding, we didn't meet the needs. that is why the overall rating is low but the hard work is very -- >> it is systematic, money, people, what is it again? i am a little confused? >> as i said it is a combination of leadership, people, money and technology. i am so acutely aware of the technology gap having come from the best technology in the world now to technology which
7:23 am
is completely outmoded. i think it is a combination of all of the above. i said i knew before coming in that the food side as your predecessor just said, food needs to be brought back to the fda, it is a major issue that will be looked at but the day i was confirmed, the recall made the news, we have been engrossed in that trying to take care of this problem for the first three months of my time. >> i don't know if anyone in this hearing that is not furious with the fda and the situation with baby formal, i don't know of any american who is not furious. commissioner, robert califf, the fda has been briefing them about baby formula situations for months going back to last year, is that an accurate statement? >> we have been communicating
7:24 am
with hhs and having communications with the secretary throughout the pandemic about baby formula. >> was it the fda's understanding the secretary would brief on the shortage and if so do you have any idea when that briefing occurred? >> i don't know, i do not know the answer to that question but we do have other communications with the white house that are regular, part of the supply chain effort which has guided us through the pandemic. >> try and find out an answer to that question about whether there was a briefing and if so, when it occurred. and also sticking with you on the questions, hhs secretary
7:25 am
becerra, providing support to the fda, what guidance and support has he provided? >> he has been tremendously helpful as we got into the operation fly formula and enforcement discretion enabling foreign suppliers, he has gotten on the phone and called ceos to encourage him to increase their production among many other efforts to support even in the last week when people know he was sequestered in germany with covid he was on the phone putting in good work. >> i don't know of anyone in this hearing that is not furious what we've been going through and what parents have been going through. someone in the administration
7:26 am
said the best suggestion was go to your pediatrician and see if they had samples for you. being the father of a pediatrician i can assure you she doesn't have cases of baby formula sitting in the back room of her office. >> i think the gentleman and mr. peters, i'm having some audio trouble with my computer. he is on deck, i appreciate it. i would like to recognize mr. taco for five minutes. >> thank you, madam chair, can you hear me? >> yes. >> has we learned over the last two years when it comes to public health guidance, communication with the american people, searching with information briefs, fear following the abbott product and in some instances led
7:27 am
families to turn to unregulated and written solutions which makes me wonder why there is so little communication in the months leading up to the voluntary recall, fda did not want the public about the potential risks of consuming infant formula products in the sturgis, michigan plant until february 17th, the company was voluntarily following these products. there have been discussions about the delay but in the benefit of hindsight and knowing the impact product recalls would have on formula supply there was more public guidance not just on the safety of the infant formula but supply opportunities in the us. >> thank you for that question. when i think about it, there were safety issues and supply
7:28 am
chain issues and when it came to safety issues i became aware and started working with the coordinated team, we worked pretty quickly to put the product off the shelves. we had information that we believed the product was unsafe and quickly communicated with actionable information and wanted them to avoid the abbott recalled products. earlier at that time i don't think there was anything to communicate to the american public. in hindsight, i'm a strong believer in transparency, maybe we could have done more talking about the supply chain but i think some type of warning that there might be supply-chain shortages coming, we did the right thing on the public health portion of safety, communicators quickly as we could and told the american public to avoid these products and pulled off the shelf and information becoming known
7:29 am
about supply chain challenges. >> would you please help shed some light on how agencies food safety leadership is coordinated with respect to the abbott investigations, the reports of infant illness description by fda, is the information shared within fda in a timely manner? >> if you're referring to the complaints associated with the infant formula not being complaints associated with the metabolic formula now, there are a few different things but back to the beginning as noted in our timeline there was a failure to escalate which was a system failure so that neither, the office of regulatory
7:30 am
affairs knew about until early february. >> i was alarmed to learn according to fda's testimony while infant formula and medical food staff received the whistleblower report in october 2021, the director did not receive the report for another four months. by that time it had been under review by the office of regulatory affairs and discussed with the office of common investigation. so is this at best a lack of coordination, a breakdown among the leadership? >> it was lack of coordination for sure. >> understanding that transpired before your tenure moving forward in your leadership as fda commissioner, how do you plan to address such
7:31 am
food safety leadership breakdowns within the agency as we go forward? >> when we think about food safety is one of your colleagues noted is broad and includes things like chemicals in the food and the sort of outbreaks we are talking about here. i knew coming and we were going to need to make changes but across the board is not just structural but also the people and resources. those need to be addressed, you can 't do that overnight. as you know, congress needs to approve any such major changes. >> thank you. the chair now recognizes mr. palmer for five minutes. >> i commend my colleagues in the committee for the thoroughness of their questions. i want to bring up an article in this morning's washington
7:32 am
post that had some stunning revelations and i want to talk to frank yiannas, you are the deputy commissioner for food policy in response, neither the fda's would policy divisions reports your work to the food safety inspectors. is that true? >> that is true. >> before commissioner kelp was appointed food safety problems were reported to the deputy commissioner janet woodcock who was a medical doctor, acting commissioner when whistleblower complaint arrived. when did you get access to that report? >> the whistleblower report i believe i got access to it around february 10th, thereabouts. >> the whistleblower report has been out for months. >> yes.
7:33 am
>> why is it as deputy administrator for food policy you didn't get informed? it got tied up in the bureaucracy and it gets to the person who should be responsible for responding to this? >> i'm not sure why the report wasn't shared with me. i will try to get to the bottom of it. >> i think we need an answer to this question. i know robert califf was not there when this occurred. this is stunning to me. robert califf, is this typical of how whistleblower reports are handled, that you don't get them to the right people? >> i haven't been involved in whistleblower reports until the last 3 months but we've done an extensive review. there were five was a blower -- >> that is not my question.
7:34 am
the question is you have the deputy commissioner for food policy who basically was shut out of the process, the old saying in management is personnel is policy. it is also management structure. i understand frank yiannas was working on the food program at the fda to ensure foods that led to the baby formula supply crisis wouldn't occur again. have you been aided or impeded in that effort? >> we had a collaborative effort, hopefully you can hear me, a collaborative effort responding to outbreaks is critical so last year -- >> what i'm asking you is, what i'm trying to find out is
7:35 am
according to the washington post you were told to stand down in that effort to reorganize so that you could actually do your job, and how the fda organized in such a manner and this is my opinion, this is not proposed. the fda focuses more on medical issues than they do food issues and that is what representative jankowski brought up where you impeded on that effort. >> i can answer, it was very unethical and outrageous behavior. i was called, the person identified themselves as somebody work with regularly who asked the question i answered, identified themselves as a reporter but that article, the investigation is read by the deputy commissioner janet
7:36 am
woodcock and steve solomon is going to have the experience. >> i'm not speaking for the entire committee but i believe it would be a consensus that we want the fda structured in such a way that when these issues arise, we know for two years the fda did not do inspections even though, when they did the inspections the report they issued didn't mention, that is not acceptable and i will yield back but i hope the committee will continue to pursue this to ensure that in the future we have the right structure at the fda to make sure this doesn't happen again and i yelled back. >> this is what i said in my opening statement and i agree totally with you about that. the chair will recognize the vice chair of the subcommittee, mister peters, for five minutes.
7:37 am
please unmute. are you ready? >> yes. i can be ready. >> you are recognized for five minutes. >> thank you, madam chair. this is a really distressing time for parents with infants and most babies even if they are breast-fed will at some point rely on formula to survive, baby formula is essentially medicine. for kids under four months, even under 6 months this is essentially their only source of nutrition, there are some
7:38 am
babies with allergies or metabolic conditions that require them to take a very specific type of formula that they can't live without. i'm glad to have this conversation as we figure out what happened, it is important to look ahead to what can be done to make sure this never happens again. when i was practicing as a pediatrician we would regularly get notifications that we were running short on certain medications, an online list of shortages. i checked it this morning, right now you mention the shortage of technetium, lidocaine, this is really important for doctors to know because it lets us make informed decisions about which antibiotics to use or which sedative to use during an operation, and whether there are alternatives. it keeps them alive, i'm
7:39 am
wondering if that kind of warning system would make sense so i want to know first is there any early warning system for products like baby formula, not just the ingredients but for formula itself, if we anticipate a shortage. >> let me thank you for being a pediatrician. i call the academy of pediatrics for the positive vibes you exude as a profession but there's not such a warning system. we repeatedly ask for that authority and have not been granted it. the industry by and large has opposed it. >> with that authority comes from congress, is that something we can do and work to make sure it happens? >> that is what i'm looking to require congressional authorization for that to happen. i want to go further to say i was at google, i know what digital technology can do. there is no reason we can't put together a national system to
7:40 am
enable us to do stress testing on the supply chain for critical products like this just like we have for banks. >> i appreciate that and understand there has been weird buying behavior, toilet paper, formula, people get nervous about omicron and baby formula, that did exacerbate this but there are other underlying issues, there's another thing i want to touch on because we are talking a lot about efforts to reopen the sturgis plant, get it up and running in two weeks and you have made some pretty damning comments about conditions net plant were found in the 2021 inspection and i read the whistleblower report and my gosh, that makes me really worried and you said you put in hundreds of requirements that they need to fulfill before that can be opened safely but when i read about falsification of records,
7:41 am
swabbing empty cans, not reporting on things, it feels like there is corruption top-down in the plant. are you insisting on a full change of staff, management, employees and how will you oversee this so that we feel confident when this opens that we are getting clean, safe formula? >> you alluded to it, to confirm or review that there may be proceedings. but with regard to the specifics of what you said every step of the way we will be there until we are comfortable not just at the plant specifically but systems and people are the right people to be in place to make sure. we can't inspect every batch of every element every month so we have to depend on quality systems.
7:42 am
>> and you have to trust the information you are getting. some of this was found coincidentally. we didn't hear about it back in september when these problems were found. questions about all the other formula companies, how sterile are there conditions? how much can we trust them and what can you say to parents out there who are worried? >> we are inspecting formula plants, the standard is once a year, we did follow up in the peak of the pandemic but we are up and the plants will be inspected once a year with a very diligent inspection so we are on top of it. >> today they are safe. >> the formula that is on sale now is safe. >> i yield back. >> thank you so much.
7:43 am
mister joyce, you're recognized for five minutes. >> thank you for yielding. just this morning after visiting a local supermarket i reached out to the head of a major supermarket chain to hear what the concerns were about the supply for baby formula. can you please elaborate and describe the plan for distribution of baby formula currently being imported from foreign countries and how that formula will reach rural parts of our country, rural parts that i represent in pennsylvania? >> let me say i appreciate, i publish a number of research papers the last five years about the decline in life expectancy and role america and the disadvantages to the people you represent compared to urban areas so we are acutely aware of that. right now the batches coming in are going to wherever infants are who are dependent on this critically special, medical
7:44 am
problems no matter where they may be and pediatricians around the country, hhs has a website, each of the producers has a number you can call. if you have an infant who requires special formula. >> my time is limited. so your recommendation is the physicians, family doctors reach out to hhs and let them know about the concerns and patients they are worried about, correct? >> special infants with metabolic disturbances that could die if they don't get formula right away, and the academy of pediatrics is very involved. talking with pediatric subspecialties, a network of communication, rural physician and recognize a shortage of rural physicians, rural physicians should be able to reach out and get help and if
7:45 am
that doesn't happen, call hhs, get on the website, we will be responsible. >> we will reach out to you from rural parts of america to do that. we understand, that is for susan mayne. the director identified at the sturgis plant, it found samples collected didn't genetically match the strains collected via samples from the six children. is that correct? >> that is correct. there were four children we have complaints, two of from had the pathogens available, two of those children had material available. when the sequencing was compared between the cases and what we found in the environment in the sturgis plant they were not the same sequences, they were not the same. >> reporter: when did the fda collect this from the sturgis facility that used to conduct
7:46 am
genetic sequence testing? >> those were part of the inspection in january where there was extensive environmental sampling done. this is a four because inspection. when we have a 4 because inspection we collect a lot of information and send samples to our lab, wait for those results and while waiting for those results we started to prepare. of those results would come up positive what would we do? >> the testing did not show the strains to be identical and if so how? >> we can't rule in or out whether or not those infants, the data simply can't be used -- >> genetic testing by the genetic testing you did did not match from the plant, correct? >> what we did not have is any sampling at the same time the product was manufactured that is consumed by individuals who got sick.
7:47 am
>> robert califf, there's been suggestion in the press the fda should have called the white house chief of staff in february when the abbot plant closed and the implication is that the fda did not reach out to the white house. when did the fda alert the white house about the closure of the abbott plant? >> in early february, communications down the chain, i know we did not -- pretty sure we didn't talk to the chief of staff, there was communication with the white house staff, a regular event and there are memos that were produced for the issues and concerns. >> what agencies are involved in the process, the white house economic advisor referenced in a recent interview? >> as you know, there are
7:48 am
multiple agencies, the cdc is involved in the agriculture department, it is an enormous participant, such a large part of the infant formula enterprise so there are multiple agencies involved in these considerations because so many, located aspects of the supply chain. >> i see my time has expired, thank you and i yield. >> >> thank you, from a public health perspective this is appalling and -- parents of twins, we relied on formula in addition to breastmilk to meet our daughters nutritional needs. i can only imagine, they desperately search for a formula and the anger they feel for the insane price they are paying online. disk should be terrifying and infuriating for any parent, even more so without the means
7:49 am
to pursue alternatives if they find empty shelves. according to the nbc news report this week prices for baby formula from online sellers like ebay and amazon, predatory sellers are taking advantage of the shortage, price gouging customers by charging 300% or more for baby formula. don't know about the rest of you but many of my constituents couldn't pay that much even if they wanted to. we are facing a huge disparity in our country in terms of who has access to basic necessities and who doesn't. i am grateful for the expertise and want to use my time to secure safe content formula and thinking of families that have been disproportionately impacted by the shortage, caregivers living in rural areas and families with infants and children who rely on specialty formula. so robert califf, fda announced
7:50 am
actions to increase availability of infant formula so i'm pleased by the news that abbott agreed to the consent decree and that its facility may be operational in a matter of weeks, formula for the children today, working american family searching for formula and those most disproportionately impacted by the recall, what can they do to get the product they need to feed their children? >> the problem you described refers me back to my days as a parent. we don't have an answer that is a great answer. we are bringing in all the supplies distributed as fast as we can. in the meanwhile i would refer people to the hhs website and you will find on the hhs website a discussion of community resources which are critical to the population that
7:51 am
you just described. great thing about america is communities that come together making supplies available at a local level so all those measures until we get back online. >> alarming reports in desperation to feed their babies some americans are looking to options like homemade formula and online scams and counterfeit, susan mayne, what do parents need to know about potentially harmful actions and what recommendations to consider and how is fda doing? >> thank you. i missed a little bit of your audio. in terms of counterfeit formulas, and purchases coming from abroad that have not been
7:52 am
through approved facilities. we urge consumers to be making their own formula. we see problems with that as well. those savings will not be getting nutrition they need. we are looking at the borders, surveying to make sure counterfeit formulas don't get into the country. those are the resources for the supplemental infant formula. >> i appreciate the administration is working to address these issues, because the president and vote the defense production act, to increase formula production. they cut transportation time from europe. we must continue this all hands
7:53 am
on deck, and how much their parents make. >> the chair recognizes mr. custer for 5 minutes. >> thank you for holding this important hearing. some complications, picking up my husband from the hospital, didn't mean to get everybody a price when i was driving in the car. settled at home, delighted to be with you. scrambling for formula, forming local donation pools and falling victim to scams and desperation. abbott bears response ability for wyatt's this -- shocked by the condition and ultimately the safe thing to do to ensure
7:54 am
the health of the infant and it will take interest the dedication to increase production that retailers can keep their shelves stocked. gerber recognizes -- i apologize, on the wrong panel. i am sorry. i'm going to have to pass, i apologize for the repetition. >> is your sound fixed, are you ready to go? >> i am. >> you are recognized for five minutes. >> thank you for holding this hearing, there is bipartisan concern with the policy of addressing it and in the context of this hearing, what
7:55 am
happened in texas, preventing children from being massacred in the school. with numerous agency actions with formula shortage making it easier for safe and nutritious products and manufacturing changes to increase supply, coordinating actions with other agencies to alleviate the shortage. >> you need to unmute. >> trying to do so well. in response to the question,
7:56 am
and economic and flowers is, i'm amazed, every weekend and night for the government response. with substantial increases in production. they wouldn't have to do but they've risen to the location at the amazing support of the global industry which for reasons you alluded to already have not been involved in implication into the united states but people are pitching in. we are not there yet but the effort has been made. >> the voluntary recall of the product. in the us today three major companies compose 95% of the
7:57 am
market, and the burden of this has fallen disproportionately with special dietary needs, 4000 families with benefits. what are the main causes for the shortage and the conditions, with grown production. and safety and quality. how much of the resources -- >> you may be on that. >> i am sorry about that. >> it was a good question. >> a little more.
7:58 am
how are you coordinating? what is the latest manufacturer of retailers and consumers? >> the manufacturers in daily conversations, almost all the ceos around the world could contribute to this. people, we are in constant communication going back and forth. each of these efforts, importation requires multiple different people to work together. >> thank you, madam chair. >> you are recognized for five minutes. >> i apologize again.
7:59 am
in the consent decree, this agreement sets in motion the critical problem of abbott retaining expert assistance to bring it into compliance. they are critical, is implemented and maintained. what updates can you share with us about implementation of the consent took 3? >> as i mentioned, we met with abbott's leadership yesterday and reviewed hundreds of staff, many of which are done. there are detailed charts and graphs recording what is happening and how close to complete they are and making substantial progress and i feel
8:00 am
optimistic about it. two months to get product out on the shelves, that has been cut to one month, decisions that have been made about the type of product put first on the line, special product for infants that have allergies on the line. i think it is going well. .. do you think i have it needs to make to improve sanitation of the facility for the fda to be confident it can safely begin production of infant formula that american consumers can rely on to safely feed their babies? dr. califf: thank you for that question. i was about to say, i have a really good history with i was about to say i have a really good history with abbott in my past as a doctor, but this was beyond the pale. so we're watching every step you are just as an example before they will open production table completely cleanse the whole production area and take samples, look at those samples,
8:01 am
then do that twice more. so that will happen three times before they open the production area. they are completely redone the roof, completely redone the floors so there is not drainage on thehe floor, and then expandd the area in which people must exert sterile precautions, whicr was too small in our inspection, and has been expanded out. there are dozens of others that i could name. >> and what, if any, contingency plans does the fda have in place to ensure the adequate availability of infant formula andth the months to come, , shod it take abbott longer than the estimated several weeks to get this sturgis plant operational again?n? >> that is a great question. and what i would say is that we are not going to stop with our importation plans and increasing our production by the other manufacturers until we are
8:02 am
comfortable that we areac back o normal levels. i would predict we will have a surplus a few months of not because we to have access for all the reasons your committee has said. there's actually substantial global s capability in infant formula. the largest manufacturer, nestlé, has a small present in the u.s. butma they are the numr one in the world. some veryy optimistic that over time we will have plenty of formula. but i don't want to make light of the fact it's going to be days to weeks until we get there. >> well, our constituents are certainly right now and as parents many of us on this committee, mothers and fathers that of dealt with feeding young babies and also my heart goes out to the people with work schedules that they have to worry about, that they are spending so much time in this trying to get safe formula for the babies, and the cost.
8:03 am
i have one last line of questioning if i could. i know that in this part of the country, i am in new hampshire, we have milk banks of mothers breast milk, and i'm wondering what is the regulation by the fda, and can we assure our constituents that breast milk from a milk banktu is safe and this thoroughly vetted by the fda? >> you're asking some veryy good question. i'm going to refer this to dr. mayne would probably have the best answer. >> thank you, congresswoman. sore human breast milk is regulated as aso food, and so tt is reassuring, and have to have proper screening protocols of things like that in place to make sure that the donors that are donating their milk, that that is critical for human food safety. so that's how i wouldon respond. >> my time is up but it will submit for the question for the record. thank you, madam chair, and thank you for your indulgence. i appreciate.
8:04 am
>> i think the gentlelady. i know you begin with a lot so our best wishes go, out to your husband today. >> thank you, madam chair. so if many of us have known and many became a riesling aware, infant foible is more regulated than most food products in the united states, reflecting the vulnerability of consumers, infants and children. robustio regulation that only interest product safety but it also lets consumers trust that the product they feed to the children is of a high-quality and will meet their babies to traditional needs. dr. mayne, in light of the search for a solution, to the nation's current formula supply shortage, some lawmakers of call for deregulating infant formula production. can youca share a bit about the nature of the regulatory standards manufacturers of infant formula must adhere to and why they are so vital to ensuring a high quality and safety of infant formula in the
8:05 am
u.s.? thank you, congresswoman. the statutes are that we need to make sure these products have appropriate nutrition as the full source of nutrition. that means they have to have the right amount of 30 different constituent vitamins, minerals, things like that. they cannot be too high, and they cannot be too low. that is the nutritional side of this. they also need to demonstrate appropriate growth. there is growth monitoring data required as a critical source of nutrition. at the same time there are safety data. when we review formulas we also work with the office of food safety to ensure the production is done in a way the product is safe. that is what the regulations require. what we did announce recently is regulatory flexibility while ensuring safety and while ensuring nutritional adequacy. and that is important. for example where we are looking for flexibility, certain labeling requirements that are not critical for safety, we
8:06 am
would provide regulatory flexibility. the label is critical for things like allergens. we don't want babies to have a reaction because allergens are not properly labeled. also, the preparation instructions are critically important. if consumers don't know how to prepare the product and you could get the wrong ratios and do not get the nutrition you need. the regulations are there to protect all of those infants. i am a mother. i am reassured we have those regulations in place. at the same time we recognize the challenge we are in and we are applying regulatory flexibilities while protecting nutritional safety. >> i appreciate that. as manufacturers expedite production of infant formula and the abbott facility completes corrective actions and restarts operation, what is the fda ensuring -- doing to ensure the available or millis remained nutritious for infants? dr. mayne: everything coming
8:07 am
into the market through our flexibilities is appropriate for nutrition and safe. so that is clear, and i will comment, as operations fly forward, one of the things we noticed we have new products coming in. it hasn't been in the market before. this is coming from u.k.. this is the product we announced very recently. that is 2 million cans of general infant formula -- not the special formulas, but general formula. he looked at the data as part of our flexibility to ensure that product meets our nutrition and food safety standards. that includes information on microbiological testing the companies have done, along with production. we are making sure these are comparable to the u.s. market with regard to nutrition and safety. rep. trahan: thank you. commissioner califf, conducting oversight is not without significant cost, and as has
8:08 am
been discussed today fda's food safety activities have been chronically under resourced. we understand you are conducting an internal investigation also regarding fda's response. you please describe the scope of that investigation and whether it will include recommendations on how to improve fda's future responses and whether the findings will be made public? dr. califf: well, let's divided into two segments. on the other hand we have the sit -- the specific response, the action that dr. solomon is leading. the interviews are well underway of the people involved. i want to stress, to my knowledge there is no malfeasance here. these were people working very hard, but we have systems that were failing and decisions that could have been better. those findings will be made public. no question about it. but there will also be a review of the entire food program, which is vast and includes things he will have discussed, including chemicals and
8:09 am
nutrition. what some of the discussion has been about over the last three months. that is going to take longer because we need congressional approval to make changes to a program like this. rep. trahan: we are eager to get those resolved and eager to get the formula back on store shelves. thank you, madam chair. i yelled back. rep. degette: thank you so much. mr. burgess, you are recognized for five minutes. rep. burgess: i'm trying to unmute. it will not let me. rep. degette: you are unmute it. >> you were. you are muted again. rep. burgess: ok. how is that? dr. caliph, very good to see you again. -- dr. califf, very good to see you again.
8:10 am
it is a terrible problem, and of course you have come on board just a couple of months ago, and this problem has landed at your feet. i appreciate the efforts you are making. it strikes me, though, that this is a time to have somebody who has spent time at the fda in the past and time in the digital world in the interim and is now back at the fda, several members have mentioned our food safety efforts even going back to 2006. during that time i remember it kept coming up that the modernization of information systems at the fda was a critical missing piece of this. it strikes me that this is an excellent time to have you there, because you are the one that can be the architect of that fda modernization, that fda digital transformation that clearly has been lacking and so critically necessary.
8:11 am
>> are you still there? rep. burgess: yeah. dr. califf: you mold me -- you want me to respond to that? rep. burgess: i wish you would. dr. califf: as i mentioned, i was enjoying a nice life under the sector -- in the private sector, and this is one of the things i thought was so critical. i did not expect to be asked to come back, so i did jump at the opportunity. i know mr. yiannis and dr. mayne have an interest in the technology. i would say i am not the architect, but i am may be the boss of the architects, because this is a -- rep. burgess: well, you referenced that you are going to need authorization help from congress, so you have come to the right place. this is the authorizing committee where we need to work together.
8:12 am
certainly i look forward to hearing from you beyond this hearing as to just what the tools are that you need to be able to implement that digital transformation. because, gosh, it has been painful listening to the timeline. october 19 for the whistleblower letter. the fda caught on that there was a problem in september, but then the whole thing kind of fell apart because there was not a new segment until february, and we are where we are now with the lack of supplies. but i am encouraged by what you said about your efforts to remedy the problems at the sturgis plant. i just wish they could have begun in october. >> go ahead. rep. burgess: just to add one more thing, i hope i can get congress to imagine the life of an fda investigator living in a
8:13 am
digital world which is modernized. how much more efficient and effective and happy those employees will be. i am 100% confident that if we get the right technology -- you say it is not just one thing, the technology and people interfacing is what is critical here? dr. califf: obviously that was the missing link between september, october, february, and where we are today. i guess the good news in all of that is you have a structured program of remedies that you are implementing at the sturgis plant. just give us an inkling as to the timeframe over which those types of tasks can be accomplished and sturgis can be up and running and producing for the american people again. dr. califf: yes sir. the sturgis plant, we met with the ceo and his team yesterday. we would expect by june 4 production will be underway, and
8:14 am
within a month from now, according to abbott's own projections, we should be having formula rolling off the production line. i've already mentioned that there are hundreds of steps along the way, so if any one of those goes wrong, you know, that will cause a further delay. but we are talking every single day, and i believe they are making best efforts at this point to make this work with all hands on deck. rep. burgess: let me ask you a question that i think was brought up dr. joyce on the similarity between the genetic makeup of the bug that caused the illnesses and deaths and what you recovered from the plant. do we need to be concerned that there are some missing pieces here, and perhaps there is part of this story that has yet to be shown to us? dr. califf: there definitely are missing pieces. i'm confident they will be filled in, for the reasons dr. mayne already sent. we don't have samples that are
8:15 am
simultaneous in the infants and their surrounding environments and the plant. i will also just point out, you are a doctor, whole genome sequencing has taken images much like facial recognition on your computer, and there are errors in sequencing, or variations that occur where you get a conclusion that something like we are not sure it matches, but we are not sure it doesn't match. so all those things can happen, which will leave us being inconclusive about those links. but we will continue to learn more. one final thing to get in -- corona back to is not a reportable bacteria. compare that to what happened with peanut butter. within days we had genotypes that linked things and were able to act. we need to make coronabacter a part of the database. rep. burgess: thank you. rep. degette: mr. o'halloran,
8:16 am
you are recognized for five minutes. rep. o'halleran: thank you, madam chair, ranking member. an incredibly frustrated that we are here today at all. as a father of three and a grandfather of four, the thought that any of -- anybody, children or grandchildren at any time in their lives, were going hungry during this critical development phase of their lives is unbearable. while clearly there are issues that must be addressed, regarding the plant, i want to hone in on the fda's failures between -- actually october and may. when the shortage of baby formula became a full-blown crisis. it actually goes back to -- oh, let's go back to the 1990's. because we have to be able to address things in an orderly
8:17 am
fashion throughout time. and there were problems with this plant back in -- back then. they have not been sufficiently brought to bear time and time again. part of my previous life i was in long-range planning, and redundancy issues. so understanding that this is not the first time this has occurred, isn't that the first time there has been conditioned that the plant that were problematic? and that this is a sole provider of some of the food for our children in this country? the abbott plant has -- or, what i heard today, has no backup plan? i come from a business that if you are down for a second, you are down. and, you know, so that is what
8:18 am
you put in redundancy across the board. to make sure on something this critical is addressed. and so our citizens do not have to have this problem. and the new york times said in an article just this weekend, long history of problems in this plant. so i don't know what the protocols are. but whatever they are, they need to be reviewed. going back in time, taking a look at other facilities, identifying clearly how not to have this happen again. and being aggressive about it. and it is sad when i hear dr. burgess say that the information systems in 2005 are still not up to the level they should be. we as a congress have to look at that too, but also administration after
8:19 am
administration have been lacking in addressing this important issue. whether it is the roof leaking -- we don't allow these at our plants that address food to our people, our citizens of this country, and especially for those most vulnerable. and when we go and look at what has heard there, i don't understand -- i fully understand, you know, that we have had an agreement, but people can work on parallel tracks. and why this wasn't -- i haven't seen where this is been worked on in a parallel track across the process. so that we anticipate that this consent agreement was going to have her and we were looking long -- working long before the consent agreement to address these issues. the ranking member, clearly
8:20 am
identify the timeline here. and in the world i come from if you have a timeline like that you have a big problem. and that should never happen. and once that timeline was -- that clock should have started taking then, and never stop until it was addressed. but i'm going to give you some time to talk about those issues, but i just had to make those comments. thank you, commissioner. dr. califf: well, i could not agree with you more about your general sentiment. he would think that a critical industry like this would have resilience plans, redundancy, but we don't even have legal authority right now to require that the firms have a plan for potential failures and resilience. that is something we have asked congress for every year for a while and we are asking for it again. so i hope that it happens this time. i would also add that this is
8:21 am
not unique to this industry. we are seeing this across the entire device and medical supply industry, with frequent failures, as exemplified by the 60 minutes show and the contrast media problem. you have got to a just-in-time, large single source contracts that lead to a lack of diversification in the industry. in the industry has fought us to -- to the nail on requiring there be insight into their supply chains so that the sum of all of the industries leads to the avoidance, the preemption. we would like to be able to a stress -- to and prevent these things rather than waiting until they happen and scrambling. i know the chair wants to move on. -- rep. o'halleran: i know that she wants to move on. we should also talk about whole planning and working on a continual basis to get things
8:22 am
right. rep. degette: i think a gentleman. we still have a second panel, so we are going to move on and we now have a number of members of the committee who have waved onto our subcommittee. we welcome you, as always. we will recognize you for five minutes. stem going to recognize representative dingell for five minutes. >> thank you, madam chair and ranking member griffith. i share the outrage of all of my colleagues and i guess there are times of want to say that everybody involved here, as we get into these trite conversations about whether this formula or this plant was contaminated, infant formula was being made and delivered in a contaminated plane. but we will talk about that in the next one. the fda's charged with the authority to ensure the nation's food supply.
8:23 am
coordination with other agencies, particularly the cdc, is crucial in times of foodborne illness outbreaks. this recent crisis has demonstrated just how vital this interagency coordination is not just for public health, but for the broader societal implications for a product millions of american families rely on for the safety and nutrition of their children. dr. mayne, following initial reports of illnesses linked to the consumption of infant formula, how did the center for food safety and applied nutrition coordinate its investigation with cdc and state department of health? dr. mayne: thank you, congresswoman. in any foodborne outbreak investigation or consumer complaint investigation we coordinate closely with the state, as well as with the centers for disease control and prevention. in this setting some of the genetic sequence data and some of the product samples, that was done with the states.
8:24 am
but we work in partnership with states to get the information we need to inform these investigations. so, close coordination throughout. as you heard our commissioner say, there is an issue that corona back to her is not -- coronabacter is not a -- the pathogen that made them sick. we did not have those tools here. what we had were two case complaints that came in. we had no idea if they were linked by a point source. we had no genetic information available. new they had consumed powdered formula from sturgis. we also know sturgis is part -- is a big part of the infant formula market. had that concern, but we need science. with the idea we could potentially one parents, had we warned parents without strong scientific justification for that he have potentially contributed to the shortages we
8:25 am
are seeing today without evidence, in fact, that there was a contamination problem. we had the inspection, we found the bacteria. we found multiple strands of bacteria in infant formula manufacturers around the country. our experts at this plant had seriously concerning conditions. unlike things they had seen in other plants in the u.s.. rep. dingell: let me build on that a little, and i'm going to give you a two-part question here. clearly all of us are going to command of this hearing saying we need to look at what we need to do to be able to get at coronabacter faster. whether process is followed for the infant formula investigation, within the same as for other foodborne illness investigations or whether factors unique to the coronabacter bacteria or infant formula? and, dr. mayne, with the benefit of hindsight, in what ways could
8:26 am
center or fda coordination with the cdc and state or federal agencies be improved? mr. yiannas: i would say the process we follow it here were the same as what we would use in an outbreak investigation. we used our coordinate an response team. that is a dedicated team of individuals, and that is their job, to investigate foodborne outbreak investigations and these critical illnesses. one of the things different in this infant formula situation is, you don't have the challenges with trace back or traceability you have and we are doing investigations. rather the parents could tell us what specific products were fed to these infants. so we use the same processes, but the data and information we had available were different in this investigation. in terms of improving coordination, we work hand-in-hand with cdc on all foodborne outbreak investigations, including this tequila situation, daily contact with cdc on these types of
8:27 am
investigations. rep. dingell: would there be changes you would recommend so we might have prevented some of what happened? mr. yiannas: in terms of prevention -- dr. mayne: in terms of prevention there are authorities we think could be helpful to prevent these types of things from happening. for example, we could consider new authorities around what industry would need to do with regard to their own testing. we have learned the importance of testing, the environment that the food production facility, so there are things industry could do if they found a bacteria. it could be provided to provide sequences to the fda to build a database of information to solve any future situations. rep. dingell: thank you, madam chair. i yelled back. rep. degette: mr. upton, you are recognized for five minutes. welcome. >> thank you for allowing me to avon. i know we have a good number of questions. there is not a bigger issue for many families than this one for us to resolve.
8:28 am
for me as a former chairman of the oversight subcommittee, and you as the current chair, we have learned from a lot of masters that have come before us. this subcommittee has been important to investigate over the years goes wrong, identified, then come back with legislation to fix it so it does not happen again. i'm actually in sturgis, michigan right now. i spent much of the morning here for a couple of hours i was at the closed habit facility, talking with the vice president of nutrition supply chain and a number of employees that have been there. some that have been there for generations. families that work in there, some as long as 40 years at that facility. i have been there a number of times over the last number of years. because i was not able to hear the witness's testimony or
8:29 am
really have, listen to some of the answers to the many questions posed by both sides of the aisle on this. important topic, i will say this and i appreciate dr. caliph's input. -- dr. califf's input. as i understand it you responded to our colleague billy long, saying he thought on a scale of one to 10 your performance you saw was about a four. you and i talked a couple weeks ago as this facility remains closed, and one of the things you told me is that, frankly, the fda needs more resources to make sure these food safety operations are safe. when chair to get and i -- chair degette and i work, we give the fda more responsibility. the fda need more resources and
8:30 am
we did that. last week, of course, the house passed $28 million in additional resources for the fda. i would imagine the senate may take that up at some point too, whether it be this week or the first week we are back. my question, dr. califf, is that if that money is approved and signed by the president, and you tell us how you are going to use that $28 million? dr. califf: first of all, we appreciate what the house is done. also appreciate what two of you did and your colleagues for 21st century cures. it has made a dramatic inference on the medical products site. on the $28 million, it is obvious from the discussions we have had we need more people that can ensure the quality of the imported infant formula, who can review the applications and get them done, and inspectors to investigate and do the testing that is needed to make sure that
8:31 am
this surge in infant formula that is going to occur happens in a safe way. as we said before, we will scrape together into it somehow without the money, but something else will suffer, and we need the dedicated funding to make this happen. have also talked about the information technology. the money allocated is a drop in the bucket compared to the ultimate need, it will at least allow us to patch together. -- paginated together. >> is a set down with abbott this morning, i would like to share this with my colleagues. it does appear -- first of all, and has been shut down since february. they made massive changes in -- inside the facility in a number of different ways. they have shared that with the fda, but they also have a third-party group to in essence certify and comply with the demands the fda has made.
8:32 am
and they intend to have the facility, as you indicated to our colleague, that it will be up, but if they don't meet, it will be later than that. they're going to make sure they are 100% for that plant is open. their senses is that if they do start on the fourth they will be able to have product and they are to pearl ties the products -- prioritize the products, working closely with the fda and white house to ensure some of those allergens are taking care of, they intend to see that supply chain be fully committed and on the shelf as early as the end of june, probably the 20th or 22nd of june, assuming they start on the fourth. again, glad to share my, i guess last quick question. dr. califf, would you be willing
8:33 am
to come back once this plant is up and running? would you be willing to come back and walk the floor with me to make sure it meets the test that all of us want to see it make? dr. califf: absolutely. i love to visit facilities and would be glad to make a home visit with you. it is the great thing about america, the way it works is you are there on the spot, this is your district. in fact -- the fact you can be there in person is a critical part of the effort. rep. degette: thank you. dr., we need to move on. i want to thank mr. upton. i understand you are in the committee room? >> yes, thank you, miss chair. thank you, madam chair for holding this hearing. i have gotten a number of calls from constituents who have had a problem getting access to infant formula. and as we have heard, people on wic have been heavily impacted.
8:34 am
my district, which is heavily working-class, and many parents on wic are really feeling this impact. they are appreciating this hearing and responses and they want to know what happened. dr. califf, we have heard today some of the -- my understanding is that people, leadership, lack of money, lack of technology to name a few. i want to talk about the position of deputy commissioner for foods at the fda. my understanding is that during the obama administration there established a role of deputy commissioner for food at the fda in 2010. and that in 2018 the prior administration that position was effectively eliminated. and dr. califf, you are an unaccomplished audiologist with expertise on drug and medical
8:35 am
policy. i'm concerned there is a lack of similarly-accomplished individuals leading the fda on food safety and the food program, which may have also led to this shortage. do you think that we need a deputy commissioner for mood to be reinstated at fda to ensure another infant formula shortage doesn't happen? dr. califf: i appreciate that question and i know a lot of people are asking it. i would respond like this. when i came through in 2016 as commissioner i had steve austria off, who had been acting commissioner, who then moved into that seat. and it was reassuring. then changes were made by dr. gottlieb and, you know, i have talked with him about why those
8:36 am
changes were made. now i have come back again. as i tried to make the point, there were deputy commissioners, and these problems we are describing are systemic and they were not fixed. i don't think it was because those are bad people, but my point is there is more to it than having a person in that particular job. what i'm trying to do over the next few months, i had planned to do this at six to nine months into my administration. we will move it up now. what i plan to do is look at the whole thing. and whenever the right structure is, you also know we have had multiple commissioners between, which changes things on and off. i would like to put in place a structure that will last, that people have confidence in. in general i agree that we definitely need a stronger team at the higher levels on the food side as part of the revamping of the entire food program. rep. barragan: we have heard some of the deficiencies at fda
8:37 am
and generally we have heard about some of these. is there anything specific you think congress should be doing to prevent this from happening again? there are a lot of things that went wrong here, and it seems that sometimes we get these solutions in generalities instead of specifics. dr. califf: we have a long list of specifics. we have gone over a number of them today, but we will be glad to compile those into a list and make sure that they are right on hand. there is this period where the user fee act -- and a number of them are included in that legislation as a possibility. rep. barragan: thank you. my next question is about the structure. who would you say is in charge of food safety at fda? dr. califf: no, i have been a part of many organizations, health systems, academic centers, as this is, and almost all of them in modern times are
8:38 am
matrices, which means you have some people with specific responsibilities. in this case dr. mayne is the authority in nutrition. how organizations work and scientific management. mr. yiannas is the authority in supply chain, how the industry works, and knows that. they have their specific responsibilities. rep. degette: thank you, doctor. let me go to dr. mayne since you mentioned that. dr. mayne, would you say you are in charge of food policy at the fda? dr. mayne: i direct the center for food safety and applied nutrition, so i leave that initiative that includes all of the scientific operations within the center. there are other components, as you heard in our organization. we work with deputy commissioner yiannis, who has oversight with the upper canned response, as well as other high-priority areas, such as the area of
8:39 am
smarter food safety. and we work with the deputy associate for affairs. rep. degette: thank you, doctor. my time has expired and i think the responses show i don't think there is one person that is responsible. it just goes to show that there needs to be restructuring and needs to be more clear who is ultimately responsible. i yelled back. rep. degette: i think the gentlelady. mr. bushong is also in the committee room. you are recognized for five minutes. >> thank you, chairwoman, and i appreciate it. i want to say, i think you for your professionalism and coming in answering the tough questions in front of the subcommittee today. i very much appreciate that. i am disappointed that it appears the leadership of the sturgis plant does not appear to have an employee-driven health and safety program in place, or they didn't listen. food manufacturing facilities i have visited in my district and state have these type of
8:40 am
programs in place. columns are addressed quickly. with -- a climate of culture and collaboration is in place. why did it take a whistleblower? the fda also clearly needs to be more nimble. and may need some operational restructuring. in addition, the noncompetitive, inflexible marketplace in infant formula needs to be thoroughly evaluated. dr. califf, with respect to additional resources and staffing, according to a recent letter sent by house appropriations chair delauro, during fiscal year 2019 congress funded 2179 full-time positions for the office of regulatory affairs. but oh allright allocated only 375 positions for food safety and inspection staff.
8:41 am
at the end of the 2019 calendar year this may have changed. that is why i'm asking. over 100 of those positions were vacant. again, why are additional resources needed for staffing if the fda has not filled the positions it already has funding for? dr. califf: i think you are asking a good question. i will have to get back with you on the details of the updates of exactly where you are. i would emphasize, this is a place in 21st century cures on the medical side we got authority to do the hiring for these very technical, scientific jobs, which are difficult to recruit for. it takes us much longer to fill the jobs on the food side because we don't have the same hiring authorities or the same ability to pay. so we very much need that in order to fill these jobs. your question about the intersection of the requests we
8:42 am
currently have? rep. bucshon: i appreciate that. it is clear many federal agencies need to update their technology. i understand that, and maybe that is where additional resources should be allocated. i just think from a congressional standpoint, just blanketing the fda with more money without specific line item things that need to be addressed is the wrong approach. the fda's testimony notes there are hardcopies of whistleblower complaints sent to three fda officials, including dr. mayne, were not forwarded from the fda mailroom. literally they were blaming the mailroom, which could be the case, but we are in 2022 here. despite the mailroom issues, according to the fda's testimony and timeline, some fda officials did receive the whistleblower complaint in october 2021, there be via email or fedex.
8:43 am
and still, dr. mayne and dr. woodcock did not receive copies of the whistleblower can claim -- whistleblower complaint until february 2021 by email. again, why did it take four months for dr. mayne and dr. woodcock to receive copies when other within the fda already were in receipt of the complaint? it seems to me this was a process problem here and not necessarily a funding problem in this area. dr. califf: this is a bigger issue, as i have stated before, is a significant process issue, of escalation criteria within the organization, which we have now fixed. people were working on the complaint and did not escalate it to the three leaders that you have discussed who really should have heard about this earlier. again, i'm not blaming the people, because it was not
8:44 am
standard procedure at the time to do so, but in retrospect it would have been much better to do it. the hard copy will be publicly addressed, but it is a technical issue and we are fixing the mailroom as we go. rep. bucshon: is the reason these were waiting for hardcopies, is it a privacy issue as it relates to emails? or that type of thing? in medicine, with hepa, hospitals a lot of times will not -- they want you to facts stuff, because it doesn't go into the cloud and it is gone. is there a substantial issue there also? dr. califf: i really don't believe that is the issue in this case. it was just standard procedure was not to escalate. people were working on it, they just cannot let the leaders know. rep. bucshon: i appreciate you coming to the committee today and being professional about it.
8:45 am
knowing that you were kind of dropped into this situation only a few months ago. i yelled back. rep. degette: thank you. i think the general meant. the chair now recognizes miss rochester for five minutes. >> nikki for holding this important and timely hearing, and thank you to the panelists for helping us better understand this crisis, particularly what happened, what is being done about it, and how we prevent this from ever happening again. delaware is among the hardest-hit states in this infant formula shortage, and protecting the health of our nation's children is a responsibility i take very seriously. as families find empty shelves at grocery stores, i am particularly concerned about reports indicating that scammers and counterfeiters are trying to take advantage of parents and caregivers' desperation, further putting the health of babies at risk. dr. mayne rec the fda is aware
8:46 am
of these scams and give advice on how parents can recognize and avoid counterfeit problems. commissioner, is the fda coordinating with other agencies such as the department of justice to end these scams and hold scammers responsible? dr. califf: we are, yes. as we can, but we have very limited resources, and as you correctly note, we do not have our own capability of enforcement. the justice department take on the case. so, it is another area, perhaps for another day, to spend time on. with the increasing availability of the internet this is a big concern, and it is especially concerned because you have a history. melamine from china, for example, the cost problems. parents have to be careful. >> you preempt in my next question, which was, does the fda have the resources it needs to effectively coordinate with
8:47 am
other federal and state agencies to combat these scammers and remove the counterfeit formula products from the market? even additionally to pat, you know, from the resources -- to that, you know, do you have the resources? it sounds like something you would have to get back to us on, but specifically we are looking at what resources you need to coordinate with these agencies. what funding authorities or flexibilities be helpful? dr. califf: i really appreciate and we will get back with you. i wish everyone could go with me to the mailroom at jfk to see what comes in that americans are buying internationally that is quite dangerous. we have very limited capabilities right now. we are doing all we can with it. >> we would love to follow-up with you on that. in your testimony you note that the wide-ranging impacts of a recall from a single formula manufacturing facility
8:48 am
underscores the risks and vulnerabilities in the supply chain when production is consolidated among major manufacturers. the bipartisan supply chain resilience subtitle of the america competes act i am leading would incentivize as this is to diversify their supply chains and prioritize investments in small and medium-sized manufacturers. how could incentivizing businesses to diversify the infant formula supply chain and increased reliance on small and medium-sized manufacturers enable the industry to better withstand any future disruption? dr. califf: as i think you know, i love this question because it is so critical and essential to the future of america. with digital technologies now there is no reason we cannot keep track of supply chains the matter where they are, and in a world with climate changes and with cyber warfare ongoing all the time, it needs to be the
8:49 am
case that if you have a critical plant in michigan, would have a second or third plant at a distant side and have digital connections among them so the second one can be activated when needed, or might have adjustment of production according to needs. the case we have in front of us also emphasizes international supply chain management, because -- and i think it exemplifies what you are saying bring it to america, that is an important part of what we need to do, get to america. we need to have digital control of supply chains on an international basis. rep. rochester: i want to thank you for your testimony and also for the answers you gave to all of us. you can see this cuts across our parties, every state. it is for the future of our country and i really appreciate it. i am also glad you bring your
8:50 am
private sector experience to solving these problems as well, so thank you so much for your testimony, andy, i yield back. -- and, madame chairwoman, i yield back. >> thank you, madam chair, and thank you for allowing me to wave onto this subcommittee. and thank all of the panelist as well. commissioner califf, i am a pharmacist, a health care profession or, -- professional, but even more importantly i am a father and grandfather. this hits home, literally. my youngest granddaughter is six-month sold, and she is on infant formula. we have a family text chain we send around, and my wife had sent a picture of the infant formula to everyone all across the country. if you see any, by we need it for mary and mm. that is how real this is, and i
8:51 am
know you recognize that, but i want to drive home the point that this is impacting all of us . and, you know, it just appears that the administration really didn't pay any attention to this until it hit the media. i mean, granted that what happened in michigan with the plant was crippling, but at the same time this has been building up for a while. so i'm disappointed in the lag and time it took to respond to this. having said that, i will say that i have always believed it is never too late to do the right thing. and when the president did invoke the defense production act, that was a good thing. as i understand it, that is going to speed up the manufacturing of u.s.-made formula and would require the suppliers to send the necessary resources to the suppliers for other customers who have requested those. what specifically do you identify those resources, commissioner?
8:52 am
in the defense production act, are those resources identified and ordered to make sure that we have that capacity and make sure they are getting to where we need them to be? you are muted. dr. califf: sorry about that. i don't know why it mutes and it's when i don't touch it, anyway, i was going to say you are from georgia, i am from south carolina. i appreciate the opportunity to wear a seersucker suit coming up. in a formula there are 30 constituents that have to be there in the right amount. this constant communication with manufacturers about what they need, i would like to ask dr. mayne to make an example of the kind of thing we are having to deal with with infant formula.
8:53 am
dr. mayne: thank you, and, yes, congressman carter, what we have seen is first the strain of their covid-19 pandemic, then the strain of the recall, and now we have the russia-ukraine conflict. you know the ukraine region is one of the world's guest exporter of products like sunflower oil. sunflower oil is used as an ingredient in many products, including baby formula. we have been working with manufacturers should they be unable to maintain their supply of sunflower oil what they would replace it with, and make sure that would meet the requirements for infant formula. it has been a constant dialogue with the manufacturers. what do they need and how can we make sure they get what they need to make these products the utmost priority? rep. carter: i appreciate knowing that. that is a great explanation and i accept that explanation. hopefully it is going to result in more u.s.-made product as soon as possible, because this
8:54 am
is an immediate problem. let me ask you this now. we are not going to inadvertently impact other areas or other production of things that are needed with these products by invoking this defense production act we? dr. califf: well, i'm going to ask dr. mayne to also comment again, but let me say it is entirely possible, which is why it is critical for everyone to realize the complexity of the supply chain group that has been working across government ever since the pandemic. this is what you call the cheap suit phenomenon. you fix one thing, then the other thing gets out of whack. this has to be looked at. dr. mayne, is there anything that comes to mind about that? dr. mayne: we have considered that. and like sunflower oil provides essential fatty acids we need in infant formulas, and we want to per euro ties it there. it is also used in products like snack foods, where they could
8:55 am
replace other oils that would work from a technical point, but are not there as a sole source of nutrition. the prioritization is done based upon the nutritional priorities of these products. rep. carter: ok. well, thank you very much for your efforts. madam chair, thank you for allowing me to avon and i yield back. -- waive on and i yield back. rep. degette: thank you for joining us. you are recognized for five minutes. >> think is so much. we are in graduation season back in florida's ninth congressional district. the pandemic has reached havoc on our supply chains, including infant formula. consolidation of industries to three or four major formula manufacturers has made our nation vulnerable. at a recall -- add a recall, and we see a major infant formula shortage.
8:56 am
congress' greatest responsibility is to the health and welfare of our children. they are literally the future of our great nation. congress is responding with action. we passed a law to boost wic, the program to help source more formula for low income families. i think president biden for invoking the defense production act, tear left a major shipment of infant formula -- multiple shipments -- to the united states. and never -- and i appreciate republicans' outrage at the hearing today, but where were you when we voted on the 28 million dollars in fda funding? thanks to mckinley for your partisan vote. the rest of you sadly voted no. we want to all make sure the sturgis plant is reopened quickly, and that takes more resources. that is why that vote is so critical. the fda is shortstaffed, and
8:57 am
this is causing further delay. it is time to work on this in an -- a bipartisan manner. dr. califf, the house just voted on an fda funding package. as the fda -- is the fda shortstaffed in the food area and would this help us long? -- us along? dr. califf: the short answer is yes. i would like to make a statement about the employees that have been working hard on this night and day, getting very little sleep, very talented, but they're just not enough of them. we really do need to increase the staffing. rep. carter: -- in line >> ma, commissioner, we are going to put our money where our mouth is. we are going to get you additional funding to make sure we have those extra resources to get that plant up and running again safely and efficiently. we are also going into a conference, the american competes act, where we are
8:58 am
looking at a host of items that are critical to national security and helping with our supply chain, boosting domestic production of critical goods for our national security, our families. medicines are part of that negotiation. when diversifying our infant formula manufacturing through the america competes act help prevent shortages like this in the future? dr. califf: absolutely. i'm privileged to be a member of the national academy of medicine and served on the resilience committee. i had to resign when i was nominated. that report gives every bit of the case you need that we must diversify not just in the u.s., but also in our international efforts, and we need to link it with digital technology to make sure we can get the the right places at the right time. >> i will yield back.
8:59 am
rep. degette: the questioning has ended but i deferred to the ranking member, if he has the last question or so. >> yes ma'am. rep. degette: you are recognized. >> thank you. it is interesting that my colleague, mr. soto, referenced that some of us did not vote for the money last week to send to the fda and the fda indicated they need money but charwoman up appropriations sent a letter saying the congress funded 2000 positions 40 ra. the or a only allocated a few positions for inspection staff. i remind everyone that someone
9:00 am
-- sometimes it is good to have these hearings. we don't need to throw money at it. i would like to ask commissioner caleb, we know there is one infant formula product that you have approved and enforcement discretion in -- on it. how many other enforcement discretionary requests are therefore infant formula pending with the fda? dr. califf: this has been an tremendous response and i will turn to dr. maine. dr. mayne: >> we also have a webinar with industry over 700 attended our webinar where we explained the data and the information that we're seeking and we ask for people to apply if they have product available if they meet our safety and nutritional standards. as of last night 26 different people applied through our
9:01 am
portal. as you heard yesterday. one of those was approved. >> thank you, and i yield back, madam chair. >> i thank the gentleman. i have one final question, and you might be able to answer this. but what-- everybody talked about this issue about the bacteriaal strains that were found in the infants that were sick and the ones that died didn't necessarily match the strains that were found in the two inspections of the abbott facility, but i want to make sure that we don't-- that we don't leave anybody with the impression that that makes -- that that means that there was no contamination of the facility or there's no problem. can you talk again, dr. taylor, or whoever, about the problems that were found and why it was necessary to take the actions the f.d.a. did? >> sure.
9:02 am
first, as we've said before, the absence of being able to prove that there was a connection doesn't mean that there was no connection. we just can't rule is in, nor can we rule it out and of course, when you make a conclusion there is a connection, that's a major thing ayn you have to have the evidence and we don't. but that's totally -- that clued us in to what needed to be done and we went to the plant. i mean, i've thought about -- let's say you had a next-door neighbor that had leaks in the roof, they didn't wash their hands, they have bacteria growing all over the kitchen. you walked in and there was standing water on the counters and the floor and the kids were walking through with mud on their shoes, no one cleaning it up, you probably wouldn't wan your infant eating in that kitchen. and that's in essence what the inspection showed. i want to emphasize again, i think that abbott is on the way, i think they're working very hard. this is not emblematic of the abbott i've known as a
9:03 am
cardiologist. so, i'm optimistic, as said, that we'll get over this to the people who work in the plant i know are hardworking people and we're not meaning to castigate them, but this is the facts that we saw. >> thank you so much, commissioner, thanks to you and your team, to all the members. we appreciate it. we do have a second panel today and so the chair will announce that we are going to take a very short break for 10 minutes and we will reconvene at 2:05 p.m. eastern time. thank you very much. >> here is what's coming up on the c-span networks. live at 9:30 a.m. eastern on c-span, the senate armed services committee considers the nomination of general to be n.a.t.o.'s top general and committee will focus on the conflict in ukraine, the future of n.a.t.o. and other topics. live on c-span2, the senate
9:04 am
returns and vote on whether to begin debate on house-passed legislation to prevent acts of domestic terrorism. 60 votes are needed. everything is alsoen or onto free c-span now video app. >> c-span brings you an unfiltered view of government. our newsletter word for word recap the day for you from the halls of congress to daily press briefings to remarks from the president. scan the qr code at the bottom and stay up-to-date on everything happening in washington each day. subscribe today using the qr code or visit to subscribe anytime. >> c-span is your unfiltered view of government who are funded by these television companies and more, including wow. he world has changed. today, the fast reliable internet connection is somethin n


info Stream Only

Uploaded by TV Archive on