tv FDA Commissioner Top FDA Officials Testify on Baby Formula Shortage CSPAN May 25, 2022 10:28pm-1:27am EDT
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the subcommittee on oversight and investigative hearing will now come to order. holding a hearing title formula safety and supply protecting the house of america's babies. today's hearing will examine the formula recall, shortage, steps needed to increase supplies and what further action we need to do to make sure families have access to formula across the country. this is the covid-19 public health emergency. members can participate in today's hearing either in person or remotely via online video conferencing. for the members participating remotely, your microphone will be set on mute with the purpose of eliminating background noise. members participating remotely
will need to unmute each time you wish to speak. please note once you unmute your microphone, they will be heard over the last speaker in the committee room and subject to be heard on the live stream and c-span. because members are participating from different locations at today's hearing, all recognition will be an order of sub committee seniority. documents for the record can be sent to austin flack and all documents will be entered into the record at the conclusion of the hearing. the chairman now recognizes herself for an opening statement today the subcommittee seeks answers on how families across the country have faced empty shelves during this nationwide infant formula shortage. we expect answers from the fda and the other two leading formula manufacturers on why caregivers are scrambling to
find the necessary nutrition they need. most importantly, we will discuss solutions that will prevent thisap from ever happeng again in the future. real consequences. nervous wrecks trying to get this. toi have heard stories from pediatricians who are seen malnourished children. i have spoken directly to desperate parents who have been driving for hours from store to store to find formula. i have heard from children hospitals who are seeing an increase in patients since caregivers have not been able to secure the formula that their infants need and unfortunately we know the crisis had a disproportionate impact on low income families. these children and their parents
are our top priorities at today's hearing. the tragic situation is unacceptable and worse it was totally preventable. in the month and the illness. there recall itself turned the formula supply into a tailspin. let's be clear. abbott is not blameless. the company neglects the essential manufacturing and cleaning processes that are in place to guarantee the safety and reliability of the products needed for most vulnerable population. today, the exact batch of contaminated and fit formula resulting in two of their deaths remain unknown. the bacterial sample of the sample taken from two of the four infants who fell ill was not found in environmental samples takenak from avid sturgs
michigan production facility. the facility has too long of a record of deficiencies. including evidence of the same potentially fatal bacterial on-site and his absence of the formulaan of 2019 and leading up to the 2021 inspection. fortunately, those batches were called before the product was released for distribution. this presents a disturbing pattern of negligence. what company alone does not bear the entire burden for landing in this current situation. there are also questions surrounding the timeline of fda's investigation response. four months left over returning to inspect the sturgis facility, the abbott employee whistleblower and flow communication to the american people. there is much more to learn about fda's actions. today we see clarity on what the
agency was b doing behind-the-scenes during this critical time. and what w lessons have been learned from the situation. i am pleased that fda and the administration have already been focused on solutions. a range of actions across the federal government to increase formula for companies in the most speciale needs. and that manufacturers are in the mix of these discussions and expediting their production efforts to meet the urgency of the moment. in fact, as well as out of it we are joined today by the other two main your manufacturers that make formula in the u.s. these companies along without it had been partnering with the biden administration to ramp up production and bring state infant formula into the country to fill the current supply gaps. the bidenbi administration's effort to coordinate this response, to get family out of the immediate crisis have been extensive and i think that we will see them working soon.
but we cannot order the need for longer-term solutions. the bottom line is that the food and drug administration needs the resources to make sure that the food part of food and drug and is not an afterthought. just as fda works to ensure lifesaving medicines are safe and effective. the agency must have the resources in the staffing to ensure that the food consumers, the food consumed is safe and reliable. fda food f safety oversight is a resource that half of the amount as a member of the subcommittee for decades, i will tell you that this is not a new problem. under resource for far too long. i am pleased that the house passed supplemental funding last week to help address the current emergency. in a one is not enough to build a more resilient safety system
e for the future. we had to work together to bolster the safety and supply chain system. not just today, but for our children's tomorrows. the empty shelves are inexcusable and caregivers scrambling to find the nutrients that their children want and need are totally heart wrenching. i stand with our colleagues and witnesses today and committing to finding solutions, permanentt solutions for the american public. now, at this time, proud to recognize the ranking member of this activity mr. griffith for an openingpe statement. >> thank you very much. thank you for holding this critically important hearing. i also want to thank commissioner caleb personally for coming to this hearing and responding to my invitation last week in a phone call that the fda arrange. the house appropriations committee hearing also last week, commissioner caleb told that he would be prepared to go
into much more detail today in tour oversight hearing. i look forward to knowing those details. parents all over the nation are experiencing anxiety as the country faces and infant formula shortage. no parent should have to worry about how they are going to feed their baby. i have heard from folks all over southwest virginia. having issues providing the most basic need for their infants. the bigbi question today is why did the biden administration let the shortage become so dire before acting withge any urgente i anticipate we will hear different excuses today and i'm not interested in debating. i am looking for answers and for a long-term plan moving forward so that this does not happen again. how did weew get here and whend this infant shortage, infant formula shortage began. the shortage issue has been on
the radar since march 2020. furthermore, the secretary has saidng they have been keeping hm apprised of the situation since last year. on the other hand, when asked if moore could have been done sooner, white house press secretary said, hindsight is always 2020. a response to criticism that the white house was too slow to respond, president biden told reporters if we would have been better mind readers, i guess that we could have, but we moved as quickly as the problem became apparent to us. so, which is it?th is the administration aware that it infant shortage was developing for over two years and failed to take sufficient action from it getting worse? no matter the reason, not acceptable. suffice to say have a lot of questions for our fda witnesses. with all the stresses on infant
formula including covid-19 disruptions in the supply chain and consumer stockpiling during the lockdowns, the availability of formula on shelves was already strained before having closed their sturgis michigan facility on february 17. the biden administration plan to deal with what should have been a foreseeable event. we did not see a plan on february 17 or 18 or march 1 or even in april. in fact, the fda did not even conclude its follow-up inspection until march 18. and it was not apparent until mid day that the fda and the biden administration took this issue seriously and began to act. why did it take an onslaught of national media attention for the biden administration to act with a sense of urgency that is required to adequately address and in formula shortage? they submitted their response and corrective action plan following the inspection on april 8, but not until may 16
did the fda working with the department of justice issue consent degree. i don't know how the fda can justify the months to respond to this crisis. i expect to learn why the fda did not, why the fda did not move heaven and earth in an attempt to get the sturgis plant back up and running as soon as possible. folks, february to june is not acceptable to the american families and american parents do not considerpa that working as soon as possible. i also have questions for the infant formula manufacturers because they do have a role in a addressing this crisis as wel. including what can be done in the short term to increase supply. what will be done in the long term to prevent something like this from ever happening again it i have questions for avid about the event that led to the shutting down of the sturgis plant. i hope to hear from abbott about the status of the plant and abbott's ongoing efforts to
safely reopen the plant. being a parent brings an incredible amount of joy, excitement and love. but it can also be an incredibly stressful time for parents. parents should not have to worry about how or if they will be able to feed their baby. the t mental health challenges associated with the inability to provide nutrition for a young infant cannot be ignored.a more must be done to address the current shortage and prevent future shortages statements like the one we heard from the president and his staff, statements like if we would have been better mind readers, we could have acted quickly. they do not inspire confidence. they deserve answers. i think the witnesses for being here on this tough issue. thank you for being a part of this important discussion. i yield back.
>> i know that you always move quickly. today because of a shortage of baby formula, parents and caregivers are seeing empty store shelves, astronomical prices online or having to drop a lot for the formula to feed their children. a dire situation occurring. thew steps taken to address it and crucially how we can prevent it from ever happening again. they will undoubtedly include legislation, congress committee has jurisdiction and will initiate the rising legislation. the data on the extent of the shortage based based on where family lives and whether a child needs a specialty formula or specific type or brand. some regions have been hit harder by the shortages than
others. low income women and children rely on the wic program for their infant formula. they have been impacted by the shortage. there shortage rates began to rise in late 2021 due to pandemic related strains on the supply chain. no question that the february recall in the shutdown of sturgis, sturgis michigan plant, the supply crash that we face today. the impact from just one plant closing in the united states shows the power of one single manufacturer to influence a nation's supply of formula when just three companies control 95% of the market. we are too reliant on too few companies to do the right thing. when one of those companies cuts corners we spiral into an emergency. the need for more competition so that the manufacturers don't have a monopoly. i stressed that. this committee will address the circumstances surrounding the recall.
the foodborne illness -- we will also ask about issues at the facility and the slow time line of action to address safety risks. at the same time, we have to address the current shortages and prevent future supply chain by hearing from the fda, abbott and other manufacturers about the supply shortages that they face and the challenges and steps for safe infant formula. the fda officials need to answer some tough questions. babies lives are at stake. this committee, congress and the american people demand answers and solutions. fortunately, the biden administration has taken important actions to increase the supply for families. working withse manufacturers to increase production that encourage safe infant formula. the president also voted the defense production act in operation five formula to increase production and bring
safe imported formula to the store shelves. also eased import restrictions for 180 days to allow international manufacturers to help address the shortage while ensuring it meets our national safety and nutrition standards. congress has already taken swift action and the president signed on saturday into law that grants flexibility to the wic program to increase the supply formula available to families. the house also passed the appropriation act providing fda with immediate resources involved in the current baby formula shortage and lay the foundation to make sure this never happens again. we have to deal more. they have been chronically underfunded, under resourced and understaffed. last week this committee took a step to help address that by advancing a user fee bill that would recruit and retain highly qualified across the agency
including an area overseeing infant formula and baby food. that bill will head to the floor in coming weeks. beitional legislation will necessary to improve transparency in reporting requirements and empower them to set limits more quickly on contamination and doing its part to ensure robust and internal controls that are being followed to prevent contaminated products from ever reaching a single child. madam chair, it should take the direct intervention to keep infant formula on the shelf. the manufacturers have to take responsibility. now we must all work together t guarantee the safety and supply of baby formula to ensure the health of our nation's children. the energy and congress committee will act as always on a bipartisan basis to enact the necessary authorizing legislation. this committee hearing is important and it will lay the groundwork for what we have to do t legislatively. thank you, madam chair and thank
you for doing so many things with this subcommittee. i do appreciate it. i lay back. >> now pleased t to recognize te ranking member of the full committee for five minutes. >> thank you, madam chair. before i begin i want to address the school shooting in texas. as a mom i kiss my children this morning and sent them off to school. i thought about it being the possibility of it being the last time that i see them. schools are where our children should be safe and learning and thriving. making friends and being kids. i know that we are all anxious to get all the information. we all want answers. there is an overwhelming sense. crime and violence is going up. a mental health crisis. these are the courageous conversations that we must have together. and i hope that we will to help
end this despair bring hope to our communities again. now, regarding today's hearing in the crisis point we have hit on baby formula shortages, parents should not have to drive hours seeing record high gas prices, visiting multiple stores to find some formula after midnight to finally feed their children just two or three days more. that is the reality of the crisis in america today. putting newborns andod babies in the hospital. parents who are unsure if tomorrow they will be able to feed their baby. they need support. immediate meaningful action to increase supply. they also deserve answers. there are several reasons for this shortage. including failure by fda in the administration acting early enough to address supply shortages. the abbott shutdown made it worse. they did not anticipate the formula shortage, but it should
have. part of the pandemic response fda had data and analytics tool to monitorly the supply chain of various products including infant formula. the fda food safety center was in contact with the formula industry to monitor ingredients and other components for productionon and maintain a safe supply. a january wall street journal article a month before the plant closed reported problems of hard to find formula. the fda did not have to read minds as the president dismissively suggested. they just had to read their own data and listen to parents. given the information, the fda should have known the plant closure would make the shortage even worse. this is not the first time the fda has been confronted with
looming supply crisis. in 2000 for the u.s. flu vaccine supply, only to manufacturers. a british company shut down roafter they found safety probls that was just before the flu season, half of the u.s. flu vaccine supply was gone. the administration immediately mtook action to secure doses of other manufacturers encourage manufacturers to seek licensure from the fda. when abbott sturgis plant closed in february, the biden administration should have likewise acted with urgency to increase supply on day one. instead the fda did not act until parents and the media emcoverage forced them to move publicly. fda failed to react promptly to the warning signs it was getting about the abbott nutrition plan.
in september 2021 they conducted an inspection and issued a 39 rtpage report that found hazards food safety practices in that product could have been contaminated. around the same time they received for complaints about tsinfections in infants. tragically, two of the babies died. all had been reportedly consumed abbott nutrition products. a link has yet to be established a 34 page complaint about the sturgis plant from an avid ex-employee that alleged data falsification and release of untested products. there was a life-and-death crisis but they failed to see the severity of these situations fda reportedly did not interview the whistleblower until months later and did not reinspect the plan until january 2022. fda did not even form a managementnt group on infant u formula until april 1 of 2022. more than six month after found
issues. this hearing is an opportunity to ensure parents are certain that the fda does not repeat mistakes that led to the shortages. i am leaning on legislation to increase and restock empty shelves. more oversight andui accountability to ensure the fda is doing its job, acting quickly we must solve the immediate issue make sure that we are taking action so that this situation never happens again. i think you and yelled back. >> the chair now ask unanimous consent that the opening statements be made part of the record. i now want to introduce our first panel of witnesses for today's hearing. doctor robert, the commissioner of the food and drug administration, welcome. frank, the deputy commissioner for food policy in response at the food and drug administration and doctor susan made the director of the center for food safety and applied nutrition of
the food and drug administration. i want to thank you offer appearing in front of our committee today. i know that you are where the committee is holding an investigative hearing and when we do so we have the practice of taking our testimony under oath he had do any of you have any obobjection to testifying under oath today. >> no objection. >> let the witnesses record shall they responded no. you are entitled to be accompanied by counsel. do and if you wish to be accompanied by counsel? >> no. >> the witnesses have responded no. t please raise your right hand o you may be sworn in. do you swear that the testimony isyou are about to give us the truth come out the whole truth and nothing but the truth? >> yes. >> let the record reflect the witnesses have responded affirmatively and you are now under oath and subject to the penalties set forth entitled 18 section 100 of the u.s. code.
at this time, the chair is very pleased to recognize commissioner for 10 minute opening statement on behalf of all three of our fda witnesses. i want to note, there is a timer on the screen. you can see it. down your remaining time. i want to thank you for appearing and recognize you for 10 minutes. >> thank you, chairwoman. members of the subcommittee, thank you for inviting us to testify on the safety and supply of infant formula in the united states. ensuring that infant formulas safe and nutritious, it is a solemn responsibility of the food and drug administration. we are working to stabilize the supply. we are fully aware that many parents and caregivers have been unable to access the infant hermela product that they need
the many of us are parents and grandparents, too. we want to express our deepest empathy for parents and caregivers who are experiencing difficulty and stress as they attempt to buy formula. i, personally, have been driven by memories my daughter spent in the infant care unit. trying to protect an innocent .child. we have provided you with an extensive written testimony that describes the recent history of this problem and gives a detailed timeline. during this hearing a welcomeis reference to this document. on september 20, 2021, fda learned about an infection in an infant that consumed formula produced at abbott nutrition facility in sturgis michigan. our detailed written testimony and type line specified the chain of events that culminated in an on-site inspection of the facility on january 31, 2022.
while there are many steps along the way, different actions could have sped up the sequence of events. i can find no evidence of intentional delay or malfeasance we have the facts delineated at this point. after action review so that we make improvements to prevent tdelays like this in the future and to improve our eddecision-making. i have asked doctor steven solomon, director for center of veterinary medicine to leave this review. before leading this, the doctor served in the office of regulatory affairs and has knowledge of the processes and the foods program as well as compliance and enforcement. the fda and cdc's investigation could not conclude that the unsanitary conditions in the abbott facility becausehe the illnesses reported on the timeline. however, we cannot rule it out
either. this is highly unusual. there is no dispute that the facility was unacceptably unsanitary.s frankly, the inspection results were shocking. standing water, cracks in the equipment that present the potential for bacterial contamination particularly in the presence of moisture. leaks in the roof, a previous citation for inadequate handwashing and current sanitation. bacteria growing for multiple sites. many signs of 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. i have used diagnostic tests and cardiovascular devices made by avid. this is so far removed from my previous experience with the company that i am very concerned as soon as we receive positive
results from environmental samples wes collected during te inspection we contacted to us a company to issue a voluntary recall. needing to make urgent action to protect the most vulnerable people, infants, presented a dilemma. this is the largest plant of the dominant manufacturer and it was sole source of a number of metabolic formulas. essential for theab viability of infants and with no substitution possible because avid had no backup plan. we knew operations would create supply problems, but we had no choice given the unsanitary conditions. we took several critical steps within hours including meeting with those that have been dealing with our supply chain withroughout the pandemic. sent to a relevant agency. we acted early to ensure the specialty metabolic and amino acid products in which abbott was a soul producer were made available on a case-by-case basis. consulting with nutritionists and safety experts.
increasing the production to supply the market. we asked retailers to place temporary limits on how much anyone person could buy to minimize access buying. we remained in frequent communication with our government and partners about the status and risk. because of the lack of diversification of thiss market and the axis of the central hub for integrating supply chains we can rooted early on that getting the facility up and running safely was a top priority. we hadad no confidence in the integrity of the program at this facility. according to the initial proceedings which requires avid to undertake steps to ensure safe production of formula including hiring an outside expert with reporting to fda. our oversight is critical, but make no mistake about it. the return to normal will only occur when they take the steps to resume production in the safe manner. as detailed in the charts
included in your written testimony, we end our federal partners have been monitoring the stocking of formula and the rates of consumption all along. through the efforts of other companies to step up their production, sales of infant hermela have remained steady in effect volume and quantity of formula purchased our five-15% higher now than in the months before the recall is demonstrated and charts included in the written testimony. despite the overall number showing diminishment steady supply we knew that distribution was an issue. some areas were experiencing shortages. overall there was enough formula to go around. .... .... 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 adequate to supply to make sure the shelves are stocked. to that end we've employed a host of measures to increase supply. the consent decree was signed last monday that will allow the plan to get back in production mode. i met with of the ceo yesterday and he assured me it would be ready to go in early june. we continue to work with the us-based manufacturers toto increase the production and distribution from the facilities. both domestically and abroad. i commend them for their efforts in this regard and we've seen substantial increases. we are helping with the all of government response including the operations and importation and a u.s. market allowed to
import formula. working with state health commissioners to increase flexibility to enable additional formula suppliers to enter the market. the highly educated group of experts inside and outside worked to manage the complex issues encountered for those with complex metabolic issues requiring very special formula. i will leave you with several thoughts first timeliness of interviewing the whistleblower and getting into the facility for the inspection or too slow and some decisions in retrospect could have beenld more optimal. i didn't return to preside over businesspr as usual. after working with public and private parts of industry i believe that success with proper attention to structure and
resources to report the work of employees. with improved operations and readership. second the return of the plan we will do everything in our power to work to make this happen as quickly and safely as possible but the timing is to control. through the enormous government partners and companies within and outside the u.s. has been heartening and while we are waiting for them to fulfill their responsibility, we will meet from a variety of sources. it didn't happen overnight.
across the industry to regulate we are seeing evidence of the just in time distribution system sparked the concentration and contracting shortages. multiple reports call for improved supply chain management until regulatory agencies have digital access to critical supply chain information and personnel to do the work and continue to react to supply chain disruptions rather than intervening to prevent them. i'm committed to improving the ability to meet its mission to protect and promote the health of the american people. thank you so much, commissioner. i appreciate the recognition of the challenges facingmi the agey and also the commitment to trying to fix it. i want to make sure we are on the same page, and i just want to go through the timeline that
was presented in your written testimony and you referred to it. from september 20th through the 24th on 2021, the fda did a routine inspection of the facility and then coincidentally on the same day september 20th, the fda got news of a complaint about an infant that had become ill due to the factor after consuming infant formula produced at that facility. but then a month later the fda got a complaint about the last cleaning at the testing facility at sturgis as well as the falsification of record and deception of fda inspectors but that person wasn't interviewed. fda received three more consumer complaints regarding two of
which sadly resulted in death but then despite all of this, fda didn't return to inspect the sturgis facility until january 31. then according you to your testimonyr there was a six week inspection and there were fundamental sanitation building equipment issues but then february as they closed down the plant in sturgis into ceased production and two days later finally voluntarily recalling the product so then on 1 march 18th fda closed the inspection and issued the inspection observation to abbott but finally may 16th and you referred to that so that was ma. it's going to take up to eight
weeks more to get back to full production, so commissioner, this is what i'm concerned about. it took about four months from when the agency first became aware of these reported cases to inspect the plan. what all of us are concerned about obviously and the parents of america are concerned about it could be up tod a year betwen the first inspection in september last year and sole soulproduction at this plant ant the same time they are not
getting their formula. so 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 the inspection and recall, and what is the plan to shorten the time in the future? >> the public should be concerned and as i said already it was too slow and there were decisions that were suboptimal along the way but also as i was going through the confirmation i had many calls from people concerned andan about the organizational structure. my basic plan has been to getga through this crisis and then we will be looking at the overallhe food program from the perspective of reforming it.
to help us get the processes correct and you mention many items and i could go through each one if you want. >> what i do want to say is that i've beene on the subcommittee for several decades now and the food program at the fda crops up time to time. we had the peanut butter crisis and many crises over the years and we always rush to make them clean it up but ultimately, but we had to do is we work together and i think that you agree with this to put food back into theti food and drug administration. we have to not just throw money at it a but what we need to do o make these inspections robusts and shorten the time.
would you agree with that? >> i 100% and applaud you for what you do on the medical products side. we need to the equivalent. if you decide means a similar shot in the arm. >> okay we will work on it. thank you so much. i'm pleased to recognize mr. griffith for five minutes. >> thank you very much. i appreciate chair degette and thank you so much for being here. it's not going to be an easy hearing and i respect you for showing up to take the tough questions. that means a lot to me. i think some could take the impression that in part at least you were blaming moms and dads and the answer is in that moms and dads are responsible for the problem it's the manufacturer's and fda. so i think that's important.
let me go into some follow-up questions. this is the kind of stuff that drives you crazy. so, through the timeline and according to the written testimony it was december 6th i know you were not there yet but they got together to say we ought to probably have a plan to inspect the sturgis plan. you said it was too slow and i was going to go with that. when you have a problem that is identified in september i'm glad that you've already agreed that getting tong do an inspection on january 301st is too late and
you stand by that and agree that that was too slow, yes or no? >> yes. the situation was going to get worse with the facility that's about 11 or 12% of the total production. what are we going to do when the kids didn't have enough formula and to be have a detailed plan. >> we have several committees that are meeting regularly and doing the things that ing mentioned which is contacting
altogether. there's not that many other producers. to the extent that they could and enumerated other actions. >> the source in the states that they can purchase a lot of times that is abbott why did it take nearly three months to say we are going to have a relaxation on some of these regulations and a relaxation onti so many of the fraud are coming in from europe. where was the request ofro the legislation. why was that happening in march instead of mid-may? >> would you prefer that i answer thegu question? >> of somebody else has an
answer, i would love to hear it. >> i would ask you to comment but we were monitoring this and the system seemed to be keeping up with demand although there were shortageses that we were responding to at the same time we were trying to get the plan up as quickly as we could about he's an expert in the outcome. can you try to move on that a little quicker and when you have 11 to 12% of the total production going down, i'm
wondering why it's taking soe long to get where we are at. why weren't we working at great speed? i'm reminded of the battle of midway when after being damaged general newman or admiral newman says we need to get this ship out and the ship is sailing and 48 hours because the american soldier got in there and got it done. i don't expect you could get a sturgis open in two days but why is it going to take four or five months and why are we moving on all these things towards getting this plant reopened then? >> you can answer briefly. >> as i say we didn't have
confidence that they would produce a safe formula until the control of the plant and the consent decree. itcr is a legal agreement involving the department of justice and the manufacturer that has to be negotiated and i would also add it was so badly met with them yesterday there were so many steps even though they've been working out. they are still not ready to go but they will be on the next several weeks. >> the chair recognizes chairman problem for five minutes.: >> i want to use half the time to talk about the current crisis particularly legislatively since we are the authorizing
committee. this has to be like a general in the field. first question the president has invoked the production act and launched. you are taking actions with abbott.ou how is this going to complement each other and will it be effective in getting the formula out quickly are you talking two weeks, three weeks, to get the shortage over withre and then as part of that how will you get information distributed so that we can tell the constituents how they get this formula, how they have access to it so they can get it. >> this is a war mentality and crisis but they have to do it now. several weeks out we will have a
surplus we are importing and flying military planes and other planes to pick it up and bring it in and we just have to keep filling in until we get to the point that the production is up. >> how about so the constituents know how to get from. they won't know how to access it and still have a problem, particularly people that don't have access to information easily. >> it's important for people to godr to the hhs website and formula. there you will find the highlight and helpful information about where to go. the distribution is beingon handled by professionals at the supply chain i that have beenro working throughout the pandemic with a variety of products so as soon as it comes in.
to hopefully get information they may need. >> let's think of other ways to get that information out before the formula becomes available hopefully in the next couple of weeks. in the authorizing committee, i am concerned about a future crisis because we need to have a mechanism. in my opinion the manufacturer's tell us this is some kind of a trigger or alarm bell if they are experiencing shortages from whatever reason, so what i'm told is we need to have some kind of transparency legislation and the potential shortages to shift production but we can go
into overload and also something to empower them to act more quickly with regards to contamination because the process is so cumbersome and regulatory. whatwh can we do so you don't gt bogged down in this long process when there is potential contamination or anything else you think. >> we've asked for a number of authorities. we requested authorities to deal specifically with thewi potentil formula shortages and we were unsuccessful in getting those acted upon yet we did a number of things to try to deal with it withth the resources that we cobbled together but you mentioned a couple of things that are critical. right now we have no ability,
is no requirement that manufacturers alert us if they are running short. secondly, for example, abbott cultured samples going back a ways but they had no requirement to keep the samples on inspection but it may surprise people to know that. the consentth decree process. for me i worked at google for five years before coming back and you would be surprised to know where all the fda employees can see what's going on. we need access to the information that manufacturers have about each of their individual supply chains. but there is no system to make sure the supply is getting where it needs to go. then i will mention it isn't
unique to this problem, this is the most special problem but right now we have a shortage of contrast media for people having strokes and heart attacks. the shortages are happening every day in the hospitals. >> recognizing the ranking member mcmorris rodgers for five minutes. >> i want to pick up where that chair man left off. as a part of the pandemic response, did fda not have a data analytic tool to monitor the supply chains into various products including infant formula? >> we requested funding for a tool and we cobbled it together. it's a start but it's nowhere near again i was at google for five years. the technology at fda and many
federal agencies is outmoded there's no question about it. >> i would like to understand more about that because as aou part of the response, congress had authorized funding for data analytics tools to monitor for various products including infant formula to monitor the agreements and others to maintain a healthy and safe supply. the full response by fda to the infant formula crisis created a desperate situation for parents for months without any actions contributed to this situation. it's suspected two babies have died and two others are critically ill from contaminated baby formula. but on top of that, with the abbott plant shutdown and possible safety problems it is
presenting another public health crisis and that is the lack of access to baby formula.of just a few days ago we learned there'se only four babies hospitalized in south carolina because of the complications arriving from the baby formula shortage. so we have an additional crisis because people cannot get the parents cannot get baby formula. how many reports does the fda half of babies that got sick or the shortage of baby formula? >> let me give a general answer to that. it's not a large number but each one is significant. i like to refer to this question working with experts on this issue. >> we've been in discussion but
it's not the same thing as a data and we do not have the authority to demand to get all the information that you would want to have to monitor the supply chains. >> to help with of this specific situation, did fda conduct an assessment of the public health impact of abd formula shortage and what were the findings? i was not here when the decision was made so i don't know all the details that i would refer again but i would say.
this would have a significant impact in the general formula but even in the metabolic products and that is why we made the decisions we did not to have those products be recalled because ofof the concerns had we recalled those products. with regards to the supply, what we heard from other manufacturers that they had capacity to increase production and they've stepped up and increased production and that was the kind of scenario planning. at the same time we also invoked steps we could things like mitigation to reduce regulatory flexibilities and things like asking the retailers to limit purchases. we did a whole number of steps from the get-go to try to reduce the impact but at the same time we ran a tough place we didn't want to allow this unsafe
formula. r >> thank you. i appreciate that. i feel like i'm getting on the one hand we are being told now that the plan is going to be up and running in a couple of weeks. i know you talked about the complaint that the integrity of the organization was compromised. so on one hand how do you believe that it can be restored in just two weeks or the expected rate opening of the plant if there are these significant concerns? >> may i have 30 seconds or so? >> given what we saw is through
the consent decree with every single step when we met with of theceo yesterday there were hundreds of steps they went through that they are having to do many of which have already been done so it's only if we have direct oversight that i would have confidence but i do have confidencee that we are seeing every single step both physically and in person and also through following the documentation and outside experts. h >> i think we have to dig a little deeper on how we can avoid the current disastrous situation in the future. we have to understand the missed opportunities and store shelves and apply those lessons going
forward. after the pandemic. we have to look at these critical products that every day americans need just to survive and make sure that this wouldn't happen. it's clear to me that the delay between the fda annual inspection of the plant in september of 2021 and the fda inspectors return in january. commissioner, understanding you are not in the position at the head of the agency today, whate steps have you taken to ensure you're not going to see, god s forbid, something like this in
the future where it's going to take four months after a notification before the fda initiates an investigation into whether it is abbott's facility or any other facility? >> there are a number of steps. the most important is the escalationt requirement that is notifying the leaders and is documented in the report and of the office of regulatory affairs were not notified until february but all this was going on and we have to have standards. they were empowered to report it to make the system better. i must tell you we still have
vulnerabilities and a tired overworked workforce in the midst of a pandemic that is stillof ongoing and an underfund segment. i've worked in corporations and health systems and it's very different then when you have really good people who can do other things for a living let me point out who are straining to do things true computers. according to the fda testimony to becoming aware of the first infant illness complaint 2021 the agency notified abbott. it's my understanding the inspectors who were on site conducting routine inspections of the plan on september 20th or the 24th and 2021 were not told about thehe reported complaint.
why were they not made aware it for the facility classification? >> once the agency receives a complaint like this we have to follow-up and every one of these was followed up on. that means that process does take time inoc this case it underwent microbiological testing. the final testing results were not available until the sixth and it does take time to get these results. so we wouldn't have known the details of what that involved and how it could potentially impact what they need to look forward to.
the moment the complaint wasla made but that's not what happened andt i will reiterate every one of these complaints they did follow up with of the procedures to get as much information about the complaint and that is critical for what you might look for in a plant. >> it is such an essential product that we need to keep children p alive. we should look at increasing domestic production on that front. thank you and i want to thank the witnesses and i will yield back the balance of my time. >> mr. burgess, you are recognized for five minutes. but you need to go on camera. i guess in going to go to mr. mckinley. you're on camera so i'm going to recognize you for five minutes. >> thank you, madam chair and thank you for the testimony and for holding this hearing.
it is one example of what happens when government agencies and the private sector companies do not get out front and disclose safety issues that impact public health. this is a multiple inspection that showed no issues at the plant and at the bill we passed last week was unnecessary the statement was just sent out last week all across the country. so the violations we've heard all through the testimony today several fda inspections established there were serious problems at the plant that led to a recall. they've escalated and there were public health crises yet the fda and the abbott company remained
silent. i remind you this statement that was put out on twitter and social media we said last week s saying the government was wrong. there were no problems there. so, i wonder there are consequences when this type of misinformation is not rebutted. the public continues to lose confidence. the administration seems to be caught off guard. so, commissioner, a couple of questions please. why did you not, i want to hear again, why did you not inform the public in january, february or earlier thatar the problems were at the abbott plant? >> with all due respect, we did call. there was a public announcement both by abbott and the fda about
the problem with the product and the general reason i would have to point out in the midst of a consent decree negotiation it's difficult to talk about the specifics. >> i have a couple of other questions. what are you doing to combat this kind of social media providing incorrect public healthcare information. how would you respond to that? >> i'm smiling not because i think it is funny but because it is critical that we get the situation under control. remember i worked at google for five years and so i saw the good and the bad of the access to information. they have to change its outlook facing the strategy to more proactive and preemptive. i would point to the american
strategy with russia and ukraine is one of the best examples of always being one day ahead of the misinformation. how would the passage of the bill increase the production of baby formula? >> it is increasing -- >> when they say it's not just one but there were several unit was unnecessary so i want to know how we get back to production putting $28 million out of that, how is that going to increase production? >> we have to make sure that it's done correctly and as we bring in a supply from other countries make sure they already have other overseas plants that
we import from on a regular basis almost double digits. so as we bring the product and we have to inspect it and make it so the quality that we inspect in america and we need to upgrade to the information systems as i've already sent it to make sure that is all this goes on we can keep track of it and make sure that we are coordinated. was there a plan in place before it was shut down? >> i think we counted in some detail we had a number of steps that we were taking to keep production up and it did increase on a national basis. thank you and i will yield back. the chair recognizes ms. schakowsky for five minutes. >> thank you madam chair. i was going to begin by saying i
am extremely concerned a lot of us have talked about the concerns i have to tell you it's more than that. i'm actually pretty furious about the lack of food safety leadership. i would ask unanimous consent by putting into the record and in depth report done by politico called the fda food failures based on 50 interviews and it really goes into detail that was donend in april of 2022 and i ak unanimous consent. food safety over the decades,
this is not a new story.k it's been a real problem. not only throughout my career but even before i became in the house of representatives. by the fda employees that says that the f in fda is silent. we haven't seen this as being a priority in the food and drug administration. i have just one question about timing although my think my colleagues have done a great job in talking about the various delays t that they had.
the complaint was received and logged in right away. the federal investigation unit because there were concerns. the decision was made then that the informant needed to behi questioned and brought in to go over things. if there were some issues that deflated.es i can't't go into details becaud they are personal and related to that. we are on record as saying it took too long and on top of that as i've already said the lack of escalation weree not aware until february 10th or february 9th.
you have a history with food and drug administration on these food sides so we are calling you to change the focus, the emphasis to put food up front. we are tired of seeing one after another of these kinds of situations. i also just wanted to alert you they deal with chemicals that are in the food that are toxic. they are known toxic chemicals and i have legislation that would require research and removalal of those. let's put food back into the food and drug administration.
the money and the technology i am so acutely aware of the gap and the technology that is completely outmoded. the food aside just as your predecessor said it needs to be brought back into the fda. it's a major issue that will be everything looked at, but the day was the day that the recall need the news and we've been trying to take care of this problem for the first three months of my time. >> i don't know of anyone in the area today that is in furious with of the fda and the situation or any american that is in furious for the record.
>> they claim that they've been breathing him about baby formula situations for months going baci the last year is that an accurate statement?ff >> we've been communicating with hhs and having communications with the secretary throughout the pandemic about baby formula. do you have any idea when that briefing occurred? >> i do not know the answer to that question. but we do have other communications at the white house that are regularly and part of the supply chain effort that is guiding us through the whole pandemic. >> could you try to find an answer to the question for me
and when it occurred? has he provided any guidance or support to the fda and if so, what guidance or support has he provided? >> he has been tremendously helpful as we've gotten into the operation formula and enforcement discretion and enabling the suppliers and he's gotten on the phone and called ceos to encourage him to increase the production with many other efforts to support even inn the last week he was on the phone putting in good work. >> i don't know anyone in the
hearing today that isn't curious of what we've been going through and what parents more importantly have been going through. someone in the administration said the best suggestion was to not go to your pediatrician and see if they have a sample of you. but check around in the back room of her office. i will yield back. >> i also want to thank mr. peters again i'm having some audio trouble with my computer. so he's on deck and i appreciate it. i would like to recognize you for five minutes. >> thank you madam chair. can you hear me? as we've learned over the past two years when it comes to public health guidance, clear
communication with the american people is vital. in some instances this led families to stockpile formula which makes me wonder why there was so little communication during the months leading up to the voluntary recalls. concerning those manufactured at the plants until february 17th following the announcement that the company was voluntarily following these products. there've been discussions about the delay but with the benefit of hindsight and now we know the impacts on the formula supply, do you think the fda could have
provided d more public guidance and on the actual supply opportunity to the u.s.? >> thank you for that question. it has safety and supply chain issues and i became aware and started working with of the coordinated team pretty quickly to pull that product off the shelves. i don't think there was anything actionable to communicate to the american public in hindsight i'm a strong believer in transparency. but there might be supply chain
shortages coming with some type of panic so we've done the right thing on the public health rtportion, the safety communicad as quickly as we could and wec told the american public they should avoidid these products ad then his information started to become known about the supply chain challenges we tried to share as much asou we could. >> could you shed some light with respect to the reports of infant illness distributed by fda and is the information f shared among the personnel within the fda in a timely manner? >> with of the complaints associated in the metabolic formulas now.
ahead of the office of the regulatory affairs knew of it until early february. >> according to the testimony while they received the former report in october of 21 the director did not receive the report which by that time had been under the review of and discussed with the fda office of criminal investigations. so yes or no is this at best a lack of coordination or the
breakdown among the leadership? >> it was a lack of coordination for sure. >> understanding this before your new tenure moving forward in the leadership with fda commissioner when we think about food safety is one of your colleagues noted it's a very broad and includes things like chemicals in the food in the sort of outbreaks that we are talking about here. there were changes across the board it's not just structural. it's also the peopling of the resources and its attempt. all those need to be addressed. you can't do that overnight. you need to plan and as you well know, congress needs to approve any such changes.
>> thank you. the chair now recognizes mr. palmer for five minutes. >> thank you, madam chair. i commend my colleagues on the committee further questions. i want to bring up the article that was in this morning's "washington post" that has stunning regulations. you were the deputy commissioner for the food policy in response yet neither of the food policy divisions records to the food safety inspectors. is that true? >> the food safety problems were reported the deputy commissioner who was a medical doctor who is acting commissioner when the whistleblower complaint arrived. when did you get access to that report?
>> the whistleblower report i believe i got access to around february 10th were there about but it had been out for months is that correct? >> yes. >> why is it then if you are the deputy commissioner you didn't get the report? i'm not sure how it didn't get escalated i think we need to get in answer to this question is this typical, that you don't get them to the right people.
>> i haven't been involved in whistleblower reports but we've done a pretty extensive review. there were five whistleblower -- >> the question is you have the deputy commissioner for food policy and response who basically was shut out of the process but it's also management structure. have you been aided were impeded in that effort?
>> responding to the outbreaks tested critically was important -- >> according to the "washington post" you were told to stand down in that effort to reorganize so that you could actually do your job. weree you impeded in that effor? >> i could answer because that was very unethical. i was called into the person identified themselves as
somebody i worked with regularly. >> i'm not speaking for the entire committee, but i believe that it would be a consensus that we want the fda structured in such a way that when these issues arise, we know that for two years the fda did not do its best even though they knew there were problems and when they did the inspections, the report didn't mention them. that is unacceptable 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 to make sure this doesn't happen again and with that i will yield back.
>> this is exactly what i said in my opening statement and i o agree totally with you about that. the chair now will recognize the vice chair of the subcommittee mr. peters for five minutes. are you ready? >> you are recognized for five minutes. >> thank you madam chair. this is a stressful time. most babies even if they are breast-fed will at some point
rely on formula to survive. essentially for kids under four months and even under six months this is essentially their only source of nutrition and there are some babies with allergies or metabolic conditions that require them to take a very specific type of formula they just can't live without. so i'm glad to be able to have this conversation today as we try to figure out what happened it's alsoig important to look ahead as my colleagues haveor pointed out so this never happens again. when i was practicing we would regularly get notifications that we were running short on certain medications and there was an online list of shortages. i checked it this morning and right now for example you mentioned lidocaine, these arepo important for doctors to know
because it lets us make informed decisions about what to use during an operation and whether there are alternatives.in i'm wondering if that kind of system would make sense so i want to know are there any warning systems not just the ingredients but for formula itself a manufacturer would let you know if you are running short. >> i sometimes call for the positive but now that there isn't such a system we repeatedly ask for that authority. >> is that something we can do
to make sure that happens? >> to require the congressional authorization for that to happen i just want to go further to say there's no i reason we don't put together the system to enable us to do stress testing on the supply chain for critical products like this. >> there's been people get nervous and start buying baby formula and that did exacerbate but there's the scent other underlining issue.
that makes you really worried and you've put in hundreds of requirements they need to fulfill before that can be opened but when i read about the falsification of records, swapping empty cans, not reporting different weights on the cans it feels there's corruption. are you insisting on the full change of staff management and employees and how are you going to oversee this so we feel confident when this happens that we are getting clean and safe formula? >> you even alluded toto it but the position to either refute or confirm the proceedings. >> with regards to the specifics every step of the way we will be there until we are comfortable not just at the plant that is
physically okay but the systems and the people to be in place. we can't inspect every branch every month so we have to depend on quality systems. i have one other question because some of this is found coincidentally like you have beenco to find a session we didt hear about it back in september when all of the problems were found. now it raises questions about all the other formula companies and how sterile are their conditions and how much can we trust them and what can you say to parents out there that are worried? >> we are inspecting plants the standard iss once a year. we did follow the work during word duringthe peak of the pandt the plants will be inspected once a year with a very diligent
inspection so we are on top of it. >> and to date they have been safe. >> the formula that is on sale now is safe. >> thank you. i willul yield back. >> mr. joyce, you are now recognized for five minutes. >> thank you for yielding, madam chair. 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 of her baby formula. commissioner, can you please elaborate and described the plan for the distribution of baby formula as being imported from the countries and how that will reach the rural parts of the country that might represent pennsylvania? >> i published a number of papers about the decline and the
life expectancy in rural america and thee disadvantages compared to urban areas. so we are acutely aware of that. right now the batches coming in are going to those that are dependent upon this critically special formula, critical medical problems no matter where they mayem be be. pediatricians are aware hhs has a website and each of the producers has a number you can call if you have a person, and infant who requires a special formula.om >> your recommendation is the pediatricians, the physicians, family doctors reach out to hhs and let them know about the concerns and the patients thatie they are worried about, correct? >> i'm talking about those with metabolic disturbances. the american academy of
pediatrics is very involved. we are talking with a subspecialty specialist daily and then at work about this. they should be able to reach out and get help and if that doesn't happen, call hhs, get on the website and we will be responsive. >> we will reach out from the parts of america to do that. we understand, and this is for the director we understand of thefda has identified the factot the plant however it found the samples collected did not genetically match the strains of the sick children. is that correct? >> there were four children we had complaints two of them had isolates for the genetic sequencing. when it was compared between the
cases and what we found in the environment and the plant, they were not the same sequences, so they were not the same. >> we collect a lot of information and send the sample to the labs and wait for the results and while we're waiting for those, we start to prepare for if the results would come up positive, what would we do. >> is it relevant to the testing did not show the strains to be identical and if so, how? >> we cannot rule whether or not it was caused by this plan. it can't be used toan inform it.
>> the testing you did does not match from the plant. >> what we do not have is any sampling done at the same time that the product. >> thank you,: director. >> there's been some suggestions in the press that the fda should have called the white house chief of staff back in february? >> in early february there were communications around the chain. i'm sure we didn't talk to the chief of staff that there was communication as a regular event and there are memos that were produced and i think they give a very elegant description the
economic advisor referenced in a recent interview. the program is such a large part of the formula enterprise in these considerations because there are so many complicated aspects to the supply chain. >> i see my time is expired. thank you and i will yield. the chair recognizes mr. louise for five minutes. >> thank you. from the public health perspective, this is appalling. we are the parents of twins and rely on the formula in addition to breastmilk to meet our daughter's nutritional needs.
i only can imagine the anxiety parents are feeling as they search for formula and the anger they feel for the prizes that they are paying on line. this would be terrifying and infuriating for any parent but even more so those without the means to pursue alternatives that they go into the stores and find empty shelves. according to the news report this week, baby formula from online sellers such as ebay, craigslist and amazon, predatory sellers are taking advantage of the shortage and price gouging by charging up to 300% or more. i don't know about the rest of you but many of my constituents couldn't pay that much so once again we are facing a huge disparity in the country in terms of who has access to basic necessities and who doesn't. i'm grateful for the expertise of the witnesses today and i want to use my time to ask them what the american people can do to secure safe infant formula for their children and particularly, thinking about the
families that have been disproportionately impacted such as low income americans, caregivers living in rural areas and families with infant children that rely on the formula. fda recently announced the availability of infant formula but i am pleased by the news abbott agreed and at the facility may be operational in a matter of weeks. american families need formula for their children today. what can american families that are searching for formula answer was most disproportionately impacted by the shortage, what can they do to get the product they need to feed their children? >> it does refer me back to my days asy a parent. we are bringing in all of the supply distributed as fast as we
can. in the meanwhile, i would refer people to the hhs website and the hotlines from the companies and you will find on the hhs website a good description of the community resources that are absolutely critical for the populations that you just described. the great thing about america is the communities have come together and are making supplies available at a local level and so -- into desperation, some americans are turning to risky options such as homemade formula. what do parents need to know about the actions and what recommendations do you have for them to consider and -- we
advise consumers to avoid purchases coming in that haven't been through the approved facilities. we also wish consumers not to make your own formula at home because we have seen problems with that as well and also not to dilute because that means they wouldn't necessarily be getting the nutrition they need. we are trying to make sure they do not come into the country. that is an important priority i appreciate the administration is working to address these issues because the act manufacturers are able to get the supply that they need more quickly to increase the formula production
and we've been able to cut the transportation times from europe from weeks to just a few days but we must continue this all hands on deck approach to make sure no child goes hungry regardless of where they live or how much their parents make and withi that, i would yield back. >> i think the gentleman. the chair now recognizes for five minutes. >> thank you madam chair and thank you for holding this incredibly important hearing. i apologize i've had some complications today but i was picking up my husband from theso hospital, so i didn't mean to give anybody a fright when i was driving in the car. i'm settled at home now and delighted to be with you. families all across the country are scrambling for formula, driving miles across state lines
and even falling victims to scans and while abbott bears responsibility for why the recall was necessary at all and i'm shocked by the conditions, it was ultimately the same thing to do to ensure the health of our infants however it's going to take the industrywide dedication to keep their shelves stocked. the testimony states gerber recognizes -- i apologize i believe that i am on the wrong panel -- i'm sorry. i'm going to have to pass and come back. i apologize for the complication. >> mr. peters, is your sound fixed now, are you ready to go?
>> you are recognized for five minutes. >> thank you for holding this hearing and i also get the sense that there is a bipartisan concern about this policy that is a bipartisan interest in addressing it. i can't get out of my mind that the context of the hearing is what happened in texas and i would like to see the same interest in preventing our children from being massacred. i would like to get to the politics on that as well. commissioner, the announced numerous actions to address the ongoing formula shortage making it easier to safe products with manufacturing changes that can increase supply. can you tell me how the fda are coordinating with other agencieo to alleviate the shortage?
>> commissioner, you need to unmute. >> i thought i was doing so well. in response to your question, we coordinate withor all of the relevant agencies including the agricultural department of ,economic advisors, supply chain committees have been in place throughout the pandemic. i've been amazed they've not been sleeping and working on weekends at night to pitch in and in the all of government response. furthermore, i think the industry is responding quite well. the amazing support of the global industry, which for reasons you've eluded to already have not been involved in the
importation. i feel people are pitching in but the effort is really being made. >> three major companies have about 95% of the market and also distribute half the products to wic agencies. we know the burden of the shortage has fallen disproportionately on families with special dietary needs. one of the main causes for the formula shortage at the michigan facility, you testified you invested, quote, billions of dollars for things like production and specialized formulas and enhancing safety and quality. how much of the resources. >> you may be on the wrong question there.
he is tomorrow. >> sorry about that. >> it was a good question. >> what is the way that you are reaching out to the manufacturers, retailers and consumers to alleviate the shortage? >> we are in daily conversations and i've personally spoken with almost all of the ceos around the world that contribute to this but the team at the working level. as you know ceos have conversations with people that are actually working to get it done so we are in constant communication going back and forth. each of these efforts for exampleio importation requires multiple different people to work together in ways.
>> i believe you are ready so you are recognized for five minutes. >> i apologize again. i was pleased by the timeliness of the agreement reached between fda and abbott filed nine days ago. this sets in motion the process of the expert assistance to bring the facility into compliance to safely restart the production of infant formula. clearly, the fda's oversight of actions would be critical to ensure the decree is properly implemented and maintained. what updates can you share with us about the consent decree in the days since its filing? >> as i mentioned yesterday, we met with the leadership and reviewed hundreds of steps that
they've taken. as i would expect from the e industry that i know well, there are very detailed charts and how close to complete they are and i do believe that they are makingg substantial progress and i feel optimistic about it in fact they were originally quoted as saying two months to get products on the shelves and that's been cutu to one month due to the decisions made about the type of product that will be paid first on the line. the product for people that have allergies to milk will be first on the line so i think it's going well. >> what change do you think they need to make to safely begin production of infant formula for american consumers can rely on to safely feed their babies? >> thank you for that question. i was about to say i have a good
history in my past as a doctor but this goes beyond the pale. just as an example before they will open up production they will completely cleanse the whole production area and take samples and then do that twice more soat that will happen three times before they opened the production area. they've completely redone the roof and the floors so there's not drainage on the floors and they've expandedav the area in which people must exert sterile precautions. there are dozens of others i could name. >> and what if any plans are in place to ensure the adequate availability of thee formula in the months to come and should it take longer than the estimated several weeks to get the plant
operational again? >> that is a great question. and what i would say is we are not going to stop with our importation lands and increasing production by the other manufacturers until we are comfortable that we are back to a normal level and i would predict we could surplus him few months from now because we want access from all the reasons that your committee has said. they have a small presence in the u.s. but they are the number one in the world p and so i am very optimistic that over time we will have plenty of formula it's going to be days to weeks until wewe can get there. >> constituents are struggling right now and many of us on the
committee, mothers and fathers that have dealt with feeding young babies and also my heartpe 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 to safe formulas for their babies. i have one line of questioning left if i could. i know that in this part of the country, in new hampshire wemo have milk banks and i'm wondering what is the regulation by the fda and can we ensure our constituents that it is safe and thoroughly vetted by the fda? >> i'm going to refer to the committee. >> thank you, congresswoman. it is regulated as a food so that is reassuring and they have to have proper screening
protocols and things like that in place. that is critical and that is how i would respond. >> my time is up but i will submit further questions for the record. thank you, madam chair for your indulgence. >> i think the gentle lady. i know you've been dealing with a lot, so best wishes go out to your husband today. you are recognized for five minutes. >> thank you, madam chair. as many of us know and have become more recently aware, reinfant formula is more regulad than most food products in the united states reflecting the vulnerabilities. robust regulation not only ensures product safety but it also helps consumers trust that the product they feed to their children is of a high quality and will meet their babies nutritional needs. in light of the search for solutions to the nation's
current formula supply shortage, some lawmakers have called for deregulating infant formula production. can you share a bit about the nature of the regulatory standard s manufacturers infant formula must adhere to and why they are so vital to ensuring the high quality and safety in the u.s.? >> i would be happy to do that. the requirements under statute are that we need to make sure these products have appropriate nutrition as a full source of nutrition. that means they have to have the right amount of the vitamins, minerals, things like that and they can't be too high and they can't be too low so that's the nutritional side of it. they also need to demonstrate appropriate growth. there is growth monitoring data required is a critical source of nutrition for our babies. at the same time there's safety data so when we review infant formulas we also work with of the office of food safety to make sure that it's done anyway the product is safe so that is
what the regulations require. what we did an ounce recently as the regulatory flexibility while ensuring safety and assuring nutritional adequacy that's important. so, things for example where we are looking for flexibility on ncertain labeling requirements that are critical for safety we would provide regulatory flexibility. the labeling is critical forl things like allergens. we don't want babies to have an allergenic relation because they are not properly labeled. also the preparation instructions are critically important as consumers don't know how to prepare the product but you could get the wrong ratio and again you don't get the nutrition you need to sow the regulations are there to protect all those infants. i am a mother and reassured we have those regulations in place, but at the same time we recognize the challenge we are in and we are applying regulatory flexibilities while protecting nutrition and safety. >> i appreciate that and as they currently expedite efforts to ramp up production of infant formula and add that to
facilities complete the corrective actions and research doing tos, what is fda ensure the available formulas remain safe and nutritious for the nation's infants? >> do you want to take that? >> everything that's coming into the markets through the flexibilities is appropriate for nutrition and it is safe so that is clear and i will comment as operations forward one of the things we know is we have new products coming in that hasn't been in the u.s. market before. this is coming from the uk. this is the product that we announced very recently. it's about a 2 million cans of general infant formula. not the specialty formulas but general infant formula. we looked at the data that is required to be submitted as part of the flexibility to ensure that the product meets the nutrition standards and that includes information on
microbiological testing the companies have done along with the production. so we are making sure they are comparable to the market with regards to nutrition and safety. >> thank you. that is reassuring. ... >> we have the specific response that doctor solomon is leading. that will go through great detail in the interviews are already underway and i want to stress again too my knowledge there is no malfeasance.
people are working very hard but we have systems we are failing in decisions that couldin be better and those findings will be made public also of the entire food program and with chemicals and nutrition that is what some of the discussion has been the last three months and those that can change a program like this. >> and even to get the formula back on store shelves. thank you madame chair. >> it's great to see you on screen. you are recognized for five minutes. >> .
>> and now listening to all the other questions it is a terrible problem and just coming aboard a couple months ago implanted at your feet i appreciate the efforts you are making during this time to haveme someone who has spent time at the fda in the past and in the digital world in the interim and now back at the fda, several members have mentioned or food safety g going back to 2005. i remember kept coming out the modernization information system that the fda was critical and it just strikes
me that it's an excellent time to have you there because you could be the architect of the fda modernization transformation that clearly has been lacking and is so critically necessary. >> as i have already mentioned i was enjoying a nice life inic the private sector living under the golden gate bridge and when the call came this is one of the things that was so critical. i did not expect to be asked to come back. i did jump at the opportunity. and those to have the key interest. and information technology and health outcomes and i would
say i'm not t the architect that may be the boss of the architects. >> you referenced the authorization bill in congress see of come to thehe right place. this is the authorizing committee of where we need to work together. and certainly i look forwardon to hearing from you for the tools that you need to implement that digital transformation and to the timeline october 19 with the whistleblower they caught on there is a problem in september and then the whole thing fell apart and we are where we are now with lack of supplies. but with your efforts tont
remedy the problem at the sturgis plant. i wish they could've begun in october. >> i hope i can get imagine congress to open the life of the fda investigator living in a digital world that ise modernized how much more efficient and effective and happy those employees will be? i am 100 percent confident. you say it's not just one thing the technology and the people that are interfacing that is so critical. >> that was the missing link from where we are today. and then to have a structured program of remedy you are implementing at the sturgis plant and give the time frame
over which those can be accomplished in sturgis can be up and running for the american people? >> we have met with the team yesterday and we might expect by june 4th production will be underway. and within one month from now according to abbott's own projections we should have formulauc rolling off the production line. if any of those goes wrong it causes a further delay but we're talking every single day. we are making best efforts at this point with all hands on deck. >> and with that genetic makeup to cause the illness and death from what you recovered from the plant. do we need to be concerned
there are missing pieces here and that there is part of the story that is yet to be shown to us? >> there are definitely missing pieces. and for thehe reasons that theve doctor has already said. but that is simultaneous with the surroundingts environments. and the with the genome sequencing takes images much like facial recognition. there are errors in the genome sequencing or variations where you get a conclusion where sure it matches that were not sure that it doesn't match. and all kinds of things that happen that leave us inconclusive but we will continue to learn more. currently not a reportable bacteria that compare that to
peanut butter within days then we had genotypes and we could act we need to make this in my opinion. >> . >> thank you ranking member for putting this together today. and as a a grandfather of four and the father of three anybody's children or grandchildren at any time inn their lives whowe has gone hungry during thisal critical development stage is unbearable. mustly there issues that be addressed regarding the plant. and with that fda failure
between october and may when it became a full-blown crisis. and going back to the 19 usnineties so we have to be able with that orderly fashion throughout time. and then with long-range planning and some understanding this is not the first time from what i heard today that is this the first time there were conditions that were problematic and the sole provider for food for
children in this country. and it has no backup plan. but if you are down for a second you are down. and that's why you put the redundancy across the board to make sure something that is critical so citizens do not have to have this problem. and just this weekend. and there are problems at the plant on what the protocol is. with the fda. but whatever they are they need to be reviewed. going back in time, taking look at other facilities andt identify clearly how not to have this happen again. but to be aggressive about it
when i hear doctor burgess say and they are still not at the level that they should be. but administration after administration has been lacking this issue. whether it is the roof leaking, we don't allow these other plants for citizens in this country. and of those that are the most vulnerable. so i don't understand but that we had an agreement.
and that this has been worked on with a parallel track across the process. and that we were working long before they consent agreement to adjust these issues. the ranking member clearly identify the timeline so if you have a timeline like that then you have a big problem. and that never should have happened. and that clock should have started taking then until it was addressed. i will give you some time to talk about thoseyo issues that had to. make those comments. >> i cannot agree more with your general sentiment. and that your industry like this would have resilience plans and redundancy and to
have legal authority that the firms have a plan for potential failures. that something we have asked congress for every year and we are asking again. and i will also add that this is not unique to this industry. we see this across the entire medical supply industry as exemplified by the 60 minute show and the contrast medium. we have gone to just-in-time large single sourceus contracts that lead to lack of diversification and then we have gone to the nail to require that every insight to their supply chain so the sum of all industries leads to the avoidance and preemption.
and then to prevent these from happening rather than waiting until they happen and scrambling. >> we have other members but and then to work on a continual basis. >> wee still have a second panel so we will move on. we have a number of members of the committee and we welcome you as always. we wills. recognize you for five minutes when we have representative dingle for five minutes. >> thank you madame chair and ranking member for convening today this critical hearing. i sure the outrage of all of gmy colleagues and the times i went to say to everybody involved if this plant was
contaminated. and then to be made and delivered. but we will talk about that in the next one. fda is charge' to ensuring the nation's food supply along with other agencies with the cdc. that is crucial to prevent foodborne illness but one —- outbreaks. this has demonstrated how intra- goal interagency coordination is for the broader supply implications for millions of american families to rely on for the safety of their children. and those linked to formula how did foodfo safety and nutrition coordinate with the state department of health? >> has any consumer complaint
as well with the cdc. and in this setting some of the genetic sequence data and the product samples was donein at the states but we work in partnership to get the information we need with the investigation. and there is an issue that says that is not a reportable disease that is something we really should be looking at because the tools we have been using based upon the molecular signature with two case complaints and they were linked by the point source know genetic information available but we also know
sturgis is a big part of the formula market. we have that concern but we need data and science and with the idea we could warn parents are had we warned them without strong scientific justification, we could potentially contributed to the shortages we're seeing today without evidence there was that contamination problem in the plant. we found the bacteria and the multiple strands in the experts at this plant has very serious concerning conditions. >> i will give you two-part question. and then tole say what we need to do to be able to get there faster but were there
processes with the investigation? was at the same as otherne foodborne illnesset investigations? there were there factors unique or to infant formula? and with the benefit of hindsight or with coordination of cdc and other state andna federal agencies be improved? >> we use our coordinated outbreak response team. that is a dedicated team of individuals and that is their investigate foodborne outbreak investigations. what is a little different with the infant formula situation is we don't have the challenges of the traceability thatat you do with our investigations. but the parents could tell use specifically what was fed to
the infants, use the same process the data and information words different on this investigation. improving coordination, we were canned in hand with all situations including daily contact withth cdc. >> other changes you would recommend today those that we do think that could be helpful in the future to prevent this from happening. and then with the new authorities what industry could do regard to their own testing. we have learned the importance of testing theth environment and the food production facility. they are things industry could do if b they found bacteria they could be required to build a sequence to build the database information for any future
situation. >> you are recognized for five minutes. >> thank you madame chair for allowing me to wave on. and it's a bigger issue but is former chair and so the sub company has been able to investigate over years. from the subcommittee. and then to make sure it doesn't happen again. and then because the abbott facility talks of the vice president of nutrition and supply-chain.
resources but now working on the 21st century cures there is a lot more responsibility. those who have provided and then we did that but last week of course $20 million additional resources for the fda. but then the first week we are back but my question is but then can you tell us a leaves the $20 million quick. >> first of all we really appreciate what the house has done and appreciate what the two of you did for the 21st century cares and has made aro dramatic difference on the medical products side.
from all the discussions we have had to have where people to ensure the quality of the imported and then to review the applications and get them done and inspectors to investigators to assess and to the testing to make sure that the surge in infant formula word occur to happen in the same way. as we said before we will get together and do it somehow without the money but something else will sufferng and we need a dedicated funding to make this happen also talking about information technology and the money allocated is a drop in the bucket at least it allows us to patch it together but it does appear, first of
all ten shutdown since february. but they made active changes inside the facility and in a number of different ways they sure that butut they also in with the demands that the fda makes and they intend to have the facility the table make sure they are 100 percent before the plant is open and but for those. the biggest needs but then
they see that the flies cheat on —- the supply-chain are fully t committed. probably through the 20th or 22d of june so again, i would be glad to share that would you be willing to come back and walk us through to make sure. >> absolutely. i love to the facilities and i would be glad but the way that it worksth is you are there on your spot and to be in person is critical of the overall unit. >> we need to move on. and i want to think mr. upton and i understand you are in the committee room? >> yes.
>> you are recognized for five minutes. >> thank you for holding this important hearing i have a number of calls from constituents who have had a problem having access to infant formula and as we have heard people haven't heavily impacted and as a very working-classs and many parents and they want to know what happened. but we have heard today some of the deficiencies that fda a combination of lack of money or state-of-the-art technology to name a few. i want to talk about the positions of a deputy commissioner for foods at the fda. my understanding is that during the obama administration to establish
the food but then with the prior administration that effectively was eliminated. you are an c accomplished. but i am i concerned there is lack and is safety in the food program i also have led to this shortage. >> do you think we needed deputy commissioner for food to be reinstated at fda to make sure another infant formula shortage does not happen? >> i appreciate that question. i know a lot of people are asking it. when i came through in 2016 as commissioner and was a food
export and then changes were made by the then looking at my those were made but now i come back again and the problems that we are describing are systemic and not fixed they are badad people but the point is thatto there is more to it a person inving that particular job. what i'm trying to do over the next few months i plan to do this between six and nine months in my administration, we will move it up because of everything that has happened to make it to the crisis. look at the whole thing. if you look at the right structure you have multiple commissioners which changes things on and off.of like to put in place and maybe
we will need a stronger team at the highest levels on the food side as part of the revamping. >> generally you have heard about these but nothing specific that congress should do to prevent this from happening again? a lot of things are going wrong and it seems that sometimes he get the solutions in general or generalities instead of specifics. >> we have a long list of specifics we will not go over them today but we will compile those into a list and make sure they are right on hand. but we are in the period where the user fee and that was
included in the legislation as a possibility. >> my next question is about the structure who is in charge of food safety at fda? >> i been a part of academic centers and health services and almost all of them in modern times are in major cities have people with specific responsibilities but he is the world's authority and how the industry works but they don't know that. >> thank you. since you just mentioned that word you say you are in charge of food policy and safety at fda quick. >> i direct a center so i leave that initiative and that includes all of the scientific
operations. there are otherhe components but other high priority areas and then the work the associate would treat that for thet operations. >> thank you. my time is respond —- expired. i don't think there's one person responsible. it just goes to show there needs to be restructuring. thank you. >> also in the committee room you are recognized for fivete minutes. madame chair woman and i but then i very
much appreciate that. i am disappointed it appears the leadership at the sturgis plant does not appear to have an employee driven health and safet' program but my visit advised that the good manufacturing facility is a problem. and then theyy may need some restructuring with the noncompetitive and flexible marketplace and infant formula needs to be thoroughly evaluated. so with respect to additional resources that that was set by
the bishop during fiscal year 2019. congress funded 2179 but at the end of 2019 calendar year, over why are additional resources needed but if the fda has not felt the positions that already has funding for. >> i think you're asking a good question. i have to get back to you with the details of exactly where you are. this is the place in 21st century cures we have authority to do the hiring
with that technical and scientific jobs which are very difficult to recruit for. it takes much longer to fill theus jobs. it doesn't have the same hiring authorities or the ability to pay so we just need to fill the jobs so the questions about the specifics of they intersection and those and then there act technology and i understand that and that's where additional resources should be allocated. from a congressional standpoint but then to know the hardcopies of the whistleblower complaint sent to three fda officials that were not forwarded from the mailroom literally blaming the mailroom which could be the
case. but we are in 2022. despite some did receive the whistleblower complaint october 2021 and also not receiving copies of the whistleblower complaint through e-mail. and again you have answered this but again, why does it take four months for them to receive copies when others were already in receipt is just not the funding in this area. but this particular but within that organization we have now
fixed. and we are working on the complaint they did not escalate that to the three leaders that should have heard about this earlier. i am not blaming the people it was not in time to do so but it would have been much better to do. >> there is but then they still want you to fax stuff because it doesn't go into the cloud and then it is gone.
>> i really don't believe that's the issue that's in yourur proceeding. >> i appreciate that and i appreciate you coming to the committee today and we're being professional about it knowing they were dropped into the situation only a few months ago. >> thank you and how do we agever prevent this from happening again? we are among the hardest hit theor end mental —- and this is a responsibility that i take period seriously. as families find empty shelves
at the grocery store, i am concerned about reports indicating scammers who are teeing —- taking and then putting the health that the babies at risk. and then toon give practical advice on how parents can recognize that commissioner such as the department of justice and to hold those scammers responsible. >> yes. but we have very b limited resources. and as you correctly note we don't have a favorability with it is another area but to have the increased availability of internet it is a great concern
and especially because you have a history of melamine from china is. >> but the resources that has effectively but have those federal and state to come back in the moved to scammers in the pv formula market even though from the resources do you have the authority and flexibility. it sounds like something you have to get back to us but specifically we're looking at what does you need to coordinate with these agencies? what funding authorities or flexibility would be helpful quick. >> i appreciate wepr will get back with you. i wish everyone could go back to theca mailroom at jfk to see what comes in internationally that is quite dangerous we
have the limited capabilities t.right now and doing all that we can. >> but also in your testimony you note the wide ranging impacts of the recall from a single manufacturing facility to understand the the supply chain when it is consolidated when few manufacturers with the facilities that bipartisan subtitle would incentivize businesses to be diversified and prioritize small and medium-sized manufacturers. instead of incentive buying.
>> i love this question because it is so critical and essential to the future of america. but with digital technologies there's no reason we cannot keep track of supply chain no matter where they are and in a world with climate change andca cyberwarfare and ongoing all the time it needs to be the case if you have a critical plan in michigan you have a second or third plan and then you have digital connections among them so the second line is activated with adjustment of production according to needs. the case emphasizes international supply chain management because i think it exemplifies suggest to say bring it to america it is an important part of what we need to do, but we need to have digital control of the supply chain on international basis.
>> thank you for your testimony and also for the answer you gave to all of us our parties and every state in the neighboring your experience and thank you for your testimony. i yield back. >> the chair recognizes mr. carter for five minutes. >> think you and thank you to the panelist for being here as well. commissioner, ima healthcare professional but even more importantly i am a father and grandfather with six grandchildren all over the country but then to turn
around and my wife and sent a picture the infant formula to everyone all across the country if you see it then buy it. that is how real this is and you recognize it but i want to drive home the point it is impacting all of us that granted what happened in the michigan plant was crippling but at the same time this has been building up for a while so i'm disappointed in the time that it took to respond to this. having said that come i always believed it's never too late to doin the right thing. wendy and president and then
to send than necessary resources before other customers who have requested those. so what specifically, do you ididentify those resources? or does the defense production act are they identified to make sure we have that capacity and they are getting to where we need them to be? >> i appreciate your accent and the chance to wear a seersucker suit. but you are also pharmacist with the complexity of the
how can we be sure they get those products as the utmost priority but then more us-made product would be as soon as possible because this is an an immediate problem. but let me ask you this. we will inadvertently impact other areas and see so it's entirely possible for everyone to realize that complexity of what has been working across government ever since the start of the pandemic. we call that the cheap suit phenomenon then you fix one thing and the other is out of
whack. that has to be looked at is everything that comes to mind? that then we went to go back to prioritize that they are. with they usehe other products i can example where they can replace other oils that would work from a textual on —- a sectional point. that prioritization is based on these traditional products. >> thank you for your efforts. thank you for allowing me andala i ways back. >> thank you mr. carter. thank you for joining us you are recognized for five minutes. >> thank you so much madame chair. we are in graduation season in my congressional district. the pandemic has returned back on our supply chains including
and with those manufacturers has laid on —- made the nation vulnerable. and with the masters sturgis plant we see a instant shortage in america. congresses responsibility as the health and welfare of our children and families. they are literally the future of and then to have more income for low income ctfamilies. and then multiple shipments across the united states. i appreciate the outreach at the hearing today that wherever you when we voted on the 20 million have emergency fda funding?
thank you for your bipartisan vote to keep the infant formula shortage. vthe rest of us packed know. we all want to make sure it is reopened quickly. that's why the vote is so critical period are short staffed it's time to work in a bipartisan manner. >> and now the house is voted on a 28 million-dollar funding package. but is the short staffed in the jet —- from that? >> yes. as one take the chance to talk about the statement of hard-working employees working on this night in day. getting very little sleep they are talented but there's just not enough of them. we really do need to increase the staffing.
>> we'll put our money whereoi our mouth is to get you additional funding and then to make sure that those extra resources to get the plant up and running again safely and efficiently and also we are going into a conference with the america competes act looking at a whole host of items that is critical to national security and for theth national security for our family and medicines are part of the negotiation to diversify the intent formula manufacturing to help prevent shortages like this in the future. >> absolutely i'm privileged to be a member of the national academy of medicine serving on the supply chain resilience. i had to resign when i was nominated so they go the right
way with the right term. >> so the funding does that help? >> absolutely. but then i would defer to the ranking member if you have the last question. but one thing they just referenced that some of us did not vote for the money last week to send to the fda and they are indicating today they read many. but the chairman of the appropriations also sent a letter stating that while congress funded 2179 positions
the or a only allocated but then just to figure out but we do need or don't need is automatically saying there is a problem a classmate sufficient for like to ask the commissioner, we know that there is one infant formula product you have approved and enforcement discretion on to bring in from the uk a foreign product for infant formula. how many of the request are there currently pending with the fda? >> this is a tremendous response and has the latest status. >> we have the regulatory
flexibility we also heldst webinar with industry over 700 attended but those to apply with product available that they thought it was nutritional standard so as of last night 26 different people. who applied to our portals. but but everybody talked about this issue that i want to make sure that and with that
combination there is no problem. but talk again, the problems that were found and why it was necessary to get the action the fda did quick. >> as we said before the absence of being able to prove there was aoe connection doesn't mean there was no connection. we just cannot rule- it in or out. of course when you make a conclusion there is a connection. that's a majornn thing and you don't have towe have the evidence but thatt is listen to what needed to be done. i have thought about if you have a next-door neighbor but has a leak in the roof bacteria is going in the kitchen understanding water
and the kids are walking through with met on their shoes and nobody cleans it up, he probably would not want to eat in the kitchen and that is what the inspection showed went to emphasize i think abbott is on the way and they are working very hard is not the added that i have known as a cardiologist. so i am optimistic that we will get over this and the people that work in the plan to hard-working people not to castigate them that these are the facts. >> thank you commissioner and to you and your team we appreciate it but we do have a second panel and that chair will announce we will take a very short break for ten minutes and reconvene at two oh 5:00 p.m. eastern. thank you very much.