tv FDA Commissioner Testifies on Baby Formula Shortage CSPAN May 26, 2022 8:59pm-11:18pm EDT
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make the tools they need for and to be ready for anything. >> along with the other television providers giving you a front roe seat to democracy. >> doctor robert is the head of the food and drug administration. he says the u.s. should consider creating a national baby formula stockpile to prevent a shortage in the future. he made the proposal while testifying before the senate house committee about the agency's handling of the current formula shortage in this part by a recall on the closing of a manufacturing plant because of unsanitary conditions. the hearing runs two hours and 15 minutes . . .
the labor and pensions committee will please come to order. today we are having a hearing on a nationwide infant formula shortage. i will have an opening statement followed by ranking member berger and then we will introduce the witness. after the witness gives his testimony, senators have five minutes for a round of questions and again while we are unable to have the hearing open to the public or media f or in person attendance, live video is available on the committee website@health dot senate .gov and if you are in need of accommodation including closed captioning please reach out to the committee for the office of congressional accessibility services. let me be clear, the fact that we even have to have this
hearing, the fact that shelves are empty and babies across the country are going hungry and parents cannot find what they need to feed their infants is a massive unacceptable failure. the groups of families that caretakers depended on to help them in this moment the fda, infant formula manufacturers get mf in my book. now parents and babies are the ones dealing with the consequences. i get that the fda needs more people and funding and i will keep pushing to get the resources needed to support your work but i still do not get by some of the steps we are seeing didn't happen a lot sooner. it's not like the fda needed
more warnings or didn't have any ideas that could be a problem. as far back as last fall, last september fda was conducting an inspection at abbott's formula many factoring facility in sturgis michigan. abbott and fda received the first report of an infant second by the coronas -- raised concerns with fda about safety issues at the facility which makes a huge amount of formula for u.s. families but it took weeks to take action on the whistleblowers complaints and months for the agency's senior leaders to see the report. a matter of life and death importance to mailroom issues. that doesn't distill confidence or explain a way that many other warnings in december fda and abbott got a second report of a
child infected. sadly, that a child passed away. in january, a third report and in february a fourth complaint and a major formula recall. senator casey and i sent a letter after recalling that way back in february when we first learned of these issues. about why it took so long to respond to these reports to work with its state, federal and global partners to make this right and to make sure that it never happened again. we asked for documents about these safety issues march 10th that deadlines came and went. about the issues related to the recall including the supply of infant formula. but still, action was slow and information has not been
forthcoming. weeks after that conversation, fda released the results of an inspection it started in january. an inspection that found contamination at the plant. later in april, reporting highlighted long-standing failures in the fda food program years long delay, culture of an inaction, decades of not prioritizing the program and it all had a very real impact on families including families who depend on formula. i will not allow the fda to continue spinning its wheels on something -- i quickly sent a letter demanding answers from you. in that letter i detailed i demanded information on how you want reform and improve the fda food program. i've not yet seen the plan. now here we are months after senator casey and i first
pressed for answers from abbott and your agency so i can't for the life of me understand why things have gotten so out of hand. there've been an important steps recently in the defense production act to make sure infant formula manufacturers or in front of the line for the ingredients they need. operations bringing millions of containers worth of formula directly to the shores including yesterday's badly needed shipment. fda announced steps to increase the supply of safe and nutritionally adequate infant formula by increasing flexibilities on importation and it has announced the sturgis facility consumes to safely resume formula production. this is all helpful but let me be crystal clear it all happened way too late. back in 2021 the first reports of the contamination emerged there should have been an
immediate fda response. back in february when senator casey and i recognized they should have been working together to make sure the shutdown of one plant didn't explode into a crisis. here we are. now i know parents will rest easy until there's formula back on the shelves or until they can feed their kids and i will not rest either. i'm going to keep pushing for more steps here in congress, from the administration and the industry to fix this as soon as possible. senator casey and i wrote a letter to the manufacturers calling on them to step up and produce more. we also sent a letter to president biden making clear there needs to be a formula coordinator at the white house leading a national strategy because we have witnessed now how multifaceted the problem is. we need a coordinated response
to ensure greater accountability from the stronger fda response and swift action from the department of agriculture to do everything it can to give the flexibility they need. we also need to make sure there's pediatricians into state and local governments that have the information and access to formula necessary to get the right formula to babies and infants with the most critical needs. we need to make sure that the retailers and suppliers are managing in a way that is focused around families that need access to formula and we need to get parents clear information and direction on what products to use, which products are the equivalent and where the products can be found. it is incredibly frustrating we have yet to see a detailed plan for this and parents are having to coordinate things themselves on facebook because the government doesn't have a point person on this. i'm going to keep pressing for
answers. a constituent of flying from washington reached out to my office last week trying to find formula for his daughter and other parents in the area. the daughter was born just six months into his wife's pregnancy and remained for four months before going home and she needs a special kind of formula to help her grow and stay healthy. because of the shortage, he's been searching high and low, day and night to try to find it and shopping at six different stores, getting donations from other parents on facebook. his dad brought six cans from milwaukee and nearly 2,000 miles away. he's constantly worried about running out and he's heard from parents across the community facing the same problem. parents that are driving to store after store are finding only empty shelves searching
online finding price cultures trying to profit off the fact that babies are going hungry. to connect parents in the tri-city area to formula. the mother and grandmother won't just go as far to milwaukee to get to their kids the formula, they will go to the ends of the earth. we should be getting them the formula and the information they need as soon as possible he can. people desperately wants to know how soon they can get the formula, their kids need to stay healthy. where should they go for it especially for people who need
specialty formula like formula for preemies or children with allergies and what is the administration doing to stop the price gouging to end the shortage as soon as possible and to ensure that this never happens again. i've been pressing hhs and the formula industry to make sure we get families the formula they need and believe me i am not going to let up until parents can rest easy and don't have to call their senators for help finding baby formula. with of the delay and dysfunction throughout the food safety and nutrition efforts not only it is unacceptably to the contaminated formula but also
the stalled progress on other critical health safety and nutrition issues. with that i will turn over to the ranking member for an opening statement. at outstrips anything we've seen and i'm appreciative for that. it's time that we hold the fda accountable. the children that are immune, compromised or on life-saving treatments. women who can't breast-feed and some cancer survivors. i want to share a story with my colleagues about one of those millions of americans.
she cares for her baby with love and devotion and had done her research on the formula shortage when she called my office to demand accountability from her government she was concerned they seemed to be blaming the formula manufacturer. abbott began flying formula to the united states from overseas in february. 11 million pounds since february, 50 flights a week, six to eight flights a day, 132,000 camps to 12 different airports across the country. there's some we haven't heard. abbott has been very transparent about what problems they faced and what they are doing to fix the problems. the ceo even published an op-ed apologizing for their part in this crisis. this month the cdc closed its investigation into the infection of four children, finding no
direct link to the manufacturer's facility, but the fda only just now began to use tools to increase the supply formula. fda still hasn't authorized the lab to resume manufacturing even though the cdc determined the original contamination did not come from the point. the question i couldn't answer is what took the fda so long. why wasn't action taken when the warning signs of the crisis started last fall. she asked if we knew what the fda stands for before we could reply, she said formula doesn't arrive. my friends, the fda failed to do its job, plain and simple. this isn't a story about funding. congress provides over $1 billion in the food center alone every year. this congress even gave them an
additional $700 million, 436 million is still available. the house passed the bill to give an additional 28 million to the fda. ladies and gentlemen, that is political cover. this money is a stunned so people could go home and say they did something. that's a dishonest at best and irresponsible at worst. the american people know better. this isn't a story about authority. the food, drug and cosmetic act authorities are clear the flexibility you have is real. this is a sad story about the fda's unwillingness and inability to do their job. during the pandemic the fda stopped its safety inspections. that seems like a bad decision and when the fda finally resumed inspections, they failed to act with speed. you were confirmed in february when the national formula
shortage was that 26%. there was a problem you manage your agency failed to solve. i challenged you at your confirmation hearing to learn lessons from the pandemic. the fda did a great job for 18 months. but when i cautioned against what's happening the fda slipping back into its bureaucratic bad ways they get $6 billion from congress each year and over 18,000 staff yet you fail to prioritize the things that matter. for the past two years the food center it ignored the formula crisis until it became a political liability. instead the center focused on reducing salt in food with kinds of salad dressing we can call french dressing and the ingredients that can be used in yogurt. yet time to decide what color additives can be added to make pharma salmon look more pink and
work on consumer acceptance. infants, babies and toddlers are facing the reality they can feed their children in the united states of america and they are more interested in policy marketing claims about cheese them and showing american families that formula is there to feed their babies. when they took steps to formula shortage had reached an alarming 43%. the fda has imperiled the health and safety of families. you've created the shortage and crisis. you've created panic and fear. yesterday and the testimony they tried to shift blame. the mailroom didn't delivery whistleblower complaint. fda knew there was a problem even before the whistleblower sent a letter strike one. yesterday you said you were new. the president hired you and the
senate confirmed you because you had been here before and your director has been there for almost a decade. strike two. yesterday you said the fda could have done a better job. that is painfully obvious, but where is the accountability. maybe that's strike three. after getting approval from your agency which it still doesn't have it will take two months for the production to go back to capacity. that will be a success for the private sector. but you are acting only now under pressure from parents and congress that deserve some serious searching. when i began my round of questions i expect that you will answer my questions in your opening statement. what did you know, when did you know and why did you fail to act for so long. the ceo apologized for their mistakes and i wonder if the fda will apologize for their mistakes.
i think the chair for the leadership on this issue and a forher shared moral outrage and forgetting the current commissioner to appear so quickly before the committee and yelled back. the witness today is the commissioner of the food and drug administration. thank you for joining us today to talk about this crisis. i know families in my state and across the country are following this closely so you may begin your testimony. >> chair marie and members of the committee, thanks for inviting us to testify on the safety and supply of infant formula in the united states. and i appreciate the ten minute allocation. ensuring infant formula is safe and nutritious is a solemn responsibility of the food and drug administration and we are working with our government partners and industry that produces infant formula to stabilize the supply. we are fully aware many parents
and caregivers have been unable to access the infant formula products that they need. many of us are grandparents and we want to express the deepest sympathy for parents and caregivers experiencing difficulties and stress as they attempt to find formula. i personally have been driven by memories of the months my daughter spent in the intensive care unit as an infant and the deep concern and anxiety of a parent driven to protect an innocent child. we provided you with an extensive written testimony that describes the recent history of this problem and gives a detailed timeline. during the hearing i welcome the reference to the document. on september 20th, 2021 the fda learned of the corona factor and an infant who consumed formula produce at the facility at sturgis michigan. our detailed written testimony and timeline specified the chain
of events that culminated the on-site inspection of the sturgis facility on january 301st 2022. there are many steps along the way where different actions could speed up the sequence of events to this day i can find no evidence of intentional delay for malfeasance. i believe we have the facts delineated at this point and we've initiated an internal after action review so we can make improvements to prevent delays like this in the future and improve our decision-making. i've asked the director of the center for veterinary medicine to lead this review. before leaving the center, doctor solomon served in the office of regulatory affairs as the organizational knowledge of the processes in the food program as well as compliance and enforcement. the fda and cdc investigation could not conclude as you stated that the outrageously sanitary conditions of the abbott facility caused the illnesses
reported in the timeline. we cannot rule it out as the fluid of events is highly unusual. there is no dispute that the facility was unacceptably unsanitary as evidenced by the consent decree. frankly the inspection results were shocking. cracks and equipment that presented potential for bacterial contamination to persist particularly in the presence of moisture. leaks in the roof, a previous citation of inadequate handwashing and current poor food sanitation, bacteria from multiple sites and many signs of disappointing lack of attention to the culture of safety in this product that is so essential to the lives of our most precious people. as a clinician i've used life-saving drugs, diagnostic tests and cardiovascular devices made by abbott. this is so far removed from the previous experience with the
company that i remain very concerned. as soon we receive positive results from environmental samples at the facility that we collected during the inspection, we contacted albert to ask the company to issue a voluntary recall. they need to take urgent action to protect the most vulnerable of all of our people, infants. this was the largest land to that manufacturer and the sole source of a number of metabolic formulas essential for the viability of infants with no substitution possible because abbott had no backup plan. we knew seizing the plan operations would create supply problems, but we had no choice given the unsanitary conditions. we took several steps including meeting with those that had been dealing with of the supply chain throughout the pandemic and a memo was sent to the relevant agencies signaling the supply chain risk. we acted early to ensure the
metabolic and amino acid products for which abbott was the sole producer were made available on a case-by-case basis consulting with nutritionists, pediatricians and safety experts. we contacted companies in the industry to encourage increasing their production to supply the market. we asked retailers to place temporary limits on how much any one person could buy to minimize. we remain in frequent communications with our government and industry partners about the status and risks. because of the lack of diversification of this market and the assets of the supply chains, we concluded early on that getting the facility up and running safely was a top priority but we had no confidence in the integrity of the quality program at this facility. accordingly initiated proceedings to the consent decree which requires abbott to undertake steps to ensure safe production of formula including hiring outside expertise with
reporting to fda. our oversight is critical but make no mistake about it the return to normal will only occur when abbott takes the steps to resume production and a safe manner. as detailed in the charts included in the written testimony, we and our federal partners have been monitoring the stocking into the rate of infant formula consumption all along. due to the efforts of other companies to step up to production, sales of infant formula have remained steady and in fact volume and quantity of formula purchased our five to 15% higher now than in the months before the recall as demonstrated in charts included in the written testimony. despite the overall no numbers showing the decline we knew distribution was an issue. some numbers experienced significant shortages but overall there was enough formula to go around. about a month ago the reports of shortages on the shelf proliferated. although there wasn't a drop in production. this increase in consumption
most likely represents the heightened concern of parents and caregivers about shortages leading to understandable efforts to purchase ahead to ensure adequate supply at home. i want to emphasize again this isn't blaming the parents and caregivers, this is rational behavior based on the concerns that they had. this type of cycle has happened with other products throughout the pandemic and we realize the only solution is to have adequate supply to make sure the shelves are stocked. to that end we then played a host of measures to increase supply. a consent decree was signed with abbott nutrition last monday that will allow the plant to get back in production mode. i met with the ceo a day before yesterday and he assured me that it would be ready to go in early june. they've now given it a date of june for those when they will be back in production. if we continue to work with the us-based manufacturers to increase the production and the distribution from fda inspected facilities both domestically and abroad. i commend them for their efforts
in this regard as we have seen substantial increases. we are hoping with the all of government response data including operation of formula encouragement and support of importation of the product not currently in the u.s. market by using careful case-by-case seizing of regulatory requirements to safely increase the number of manufacturers allowed to import formula working with state health commissioners to increase flexibility with contracts to enable additional infant formula supplies into the market and to catch price cultures. the experts have worked to manage the complex issues encountered for those caring for infants requiring three special formula. i will leave you with several thoughts. first the fda timeliness of interviewing the whistleblower and getting into the facility for the cause inspection were too slow and some decisions
could have been more optimal. i couldn't pray side of business as usual after years of working in the public and private parts of the industry i believe that success follows proper attention to structure the function leadership and resources. these need attention and the in thechronically underfunded fd side of the fda and you will see changes in the near future. the request for funding and authority are essential in concert with improved operations and leadership. second, the return of the plant to the safe production of formula is critical. abbott's enormous marketshare left it with a responsibility for producing safe infant formula that was not met. we will do everything in our power to make this happen as quickly and safely as possible, but this timing is in abbott's control. third, the all of government effort and enormous goodwill of government partners and
companies within and outside the u.s. has been heartening and while we are waiting for abbott to fulfill its responsibility, we will meet with a variety of sources. fourth, the supply of inadequacy didn't happen overnight. across the industries we regulate we are seeing evidence of the just-in-time distribution system, market concentration and contracting order leading to shortages. multiple reports to congress call for improved supply chain management. until regulatory agencies have access to critical supply chain information and personnel to do the work, we will continue to react as the disruptions rather than intervene to prevent them. i want to conclude by reiterating we will not rest until the shelves are safe and nutrition nutritious infant formula and i'm committed to meet the mission to protect and promote the health of american people particularly infants, the
most vulnerable people. thank you. >> we will begin a round of five-minute questions you might ask my colleagues to keep track of the clocks in those five minutes. parents and caregivers across the country rely on the fda and the handful of dominant formula manufacturers to make sure that formula they feed their babies meets the highest standard of safety and nutrition. but the companies and fda let them down. i am ready and willing to work to continue working with you and absolutely anyone to get this right and make sure we are never in this situation again but i want to be clear about where we are in the current moment. babies have gotten sick and to have died after drinking formula from abbott nutrition michigan facility and it took months, months in fact you are telling us today it took six months for fda to investigate. during that time, they continued to produce formula at the michigan plant when fda finally
completed an on-site inspection months after the first baby became ill it found evidence of the bacteria on a surface is sue formula was being produced and a history of finished baby products. that is incredibly alarming so it makes sense the plant was shut down as abbott and fda tried to figure out why babies were getting sick and as your inspectors uncovered a substantial long-term problems at the facility. what doesn't make sense, but i can't for the life of me figure out is why it took so long to investigate in the first place. why did so much time passed before the fda took serious action to investigate this contamination and baby formula? >> while i appreciate the question and i think we all have a great degree of sorrow over the difficulties you are describing. many people at fda are not sleeping at night in our working
weekends trying to get this corrected. there's no question it's just not good -- >> i'm asking why did it take so much time. >> i want to parse one issue. there's disagreements with senator burr about some things that were said but from the first case there was an investigation going on. it didn't take six months to start the investigation. the very first case you have to collect samples. >> i'm asking why it took six months to take serious action. >> the answer to the question is as in our document there are systemic issues at fda and in our interactions with of the industry and authorities that need to be corrected. >> do you have a plan to do that? >> yes. >> when can we see it? >> when can you see the plan? >> correct. >> we have a plan but a complete plan written out we will have to get to you as soon as we can. i can't give an exact date right
now. >> have they told you why it kept producing formula when they knew it might be dangerous for babies? >> they have not and i will remind you that we ended up in legal proceedings. we couldn't get control of the quality and the plant without going through a consent decree process which is omitted ability to discuss it because it's a serious legal proceeding as you know. what i do know is they now have good plans underway overseeing every step of the way. >> for parents of preemies like my constituent, what is the message from the fda on how and where he is going to get an equivalent formula for preemies? >> any infants requiring specialty formula we have a committee on a whole host of pediatricians and specialists who are constantly in contact. the physician involved should be
able to contact for the specialist societies access to the needed formula. >> but i am asking exactly what should parents no? i want to be able to say you, secretary becerra, are telling him directly where he can go to get the formula. >> a parent should start with a pediatrician and if the pediatrician is not in the loop one should go to the hhs website and call hhs and we will intervene directly to help out. there's a committee in place to do that for each individual. >> i expect you to do everything as possible what they should know to keep their babies out of the hospital, very clear direct across the country. >> thank you madam chair.
they submitted the paperwork for the facility to the fda on aprie facility is still closed. do you have permanent inspectors every day in the facility helping identify the contaminations that the inspectors found? >> you have some incorrect information. they didn't submit adequate documentation on the dates that you referred. >> do you have inspectors today in the facility every day helping them get the plant up and running? >> we have inspectors working there every day. >> why haven't you way up to the requirements from the manufacturers in countries like the uk, australia or canada and couldn't the manufacturers provide temporary labels on imported formula and if it is printed in a language other than english until the u.s. manufacturing is restored? some countries have higher nutritional requirements.
why can't we provide a waiver for their products to come into their countries? >> we have waived many of the requirements that make sense but the directions have to be clear to americans in a language that is understandable so that the formula can be mixed correctly. an error in mixing of the formula for example can lead to a very significant of not getting the right nutrition. >> complacency is the fda's catchphrase when it comes to infant formula. fy 21 they received 42 submissions for new infant formulas. the agency was able to review only 15 of those missions within 90 days. that's one third. what happened to the other submissions, did you expedite the review with the new formula when you took the helm at the fda in the midst of the growing shortage and by law the fda has 90 days to review new infant formula manufacturing submissions. what is the average number of days that it actually takes to
review these? >> senator, the fda employees are working around the clock and they are hard-working people, so i somewhat resent the implication of part of that. but -- >> there is a number that's defended the fda and the more than this one and there is no member in congress that has tried to fix the areas when they were broken more than this one. if you want to get into this with me i'm happy to do it. i have 28 years worth of it. >> i know you are quite capable of that so let me just say right from the start, any good application was expedited by the fda since the shortage came evident. >> so 42 minus 15. the rest of them were not. >> it has a staff of 4,000
people but according to your own budget documents there's only nine staff reviewing infant formula applications. did you or other leaders assign any staff to review infant formula as a shortage as the percentages rose sharply? >> we called in people from all over the agency to help which of course -- >> i will have to go back and see how they spend their time. but looking at all of the activities of that group, they were supplemented by staff across the agency which means other things didn't get done. >> the authority as the commissioner to move people around as needed? >> yes. >> i've looked at the initial review of the activities of the food center and i'm concerned with your activities in the staff you have since the voluntary recall, since the voluntary recall for infant
formula. the food center spend time making changes to the definition of yogurt opining on color additives and fish food so forms can raise salmon that looks more pink. making announcements about the use of the term of the definition healthy. since the first infant hospitalization the same center issued a rule of the definition of french dressing and issued guidance on chocolate, cheese and chocolate straight from the official definition. this is a pattern over the last decade, the same senator has gone after salt, sprinkles and the definition of frozen cherry pie. so my question is simply what are your priorities at the food center? >> the food center has a broad set of mandates as you know, but there's nothing more high-priority of them and what we are discussing today. it's the highest priority. we are assigning every resource that we can to work on this
problem. >> i hope the chair's request did not fall on deaf ears and a detailed comprehensive plan should be something that you can produce now if in fact the agency is working at an expedited piece that you addressed. if it's not ready today i hope it is in the very near future. thank you madam chair. >> senator sanders. >> thank you madam chair. concentration of ownership in our economy is a major problem in many sectors. it's true on wall street and it's true in energy and food production in general and it's certainly true in the production of infant formula which is so terribly important to millions of parents with babies. right now we have three companies, amit, mead and nestée who dominate the market.
we have recently been discussing contamination at an avid facility. abbott facility. tomorrow it could be nestlé. are you concerned and what are you doing about broadening the number of companies who are producing infant formula? >> i'm very concerned and as i said in my opening remarks, it's not unique to this industry that we are seeing concentration that puts everything at risk and i will remind you as you know there is no requirement that companies show their backup plans. >> all i'm asking. i have other questions. what are you doing right now to make sure that more companies are producing infant formula so that we will not see this problem again. >> i'm sorry, senator i give to interrupt. on a temporary measure, we have lowered, reduced some of the paperwork so that many more manufacturers can import. we have 26 applications since we
opened the portal just over a week ago. the largest producer, nestlé worldwide hardly had any presence in the u.s. and they are going to help out quite a bit. >> i hope that you will focus on increasing the number of companies who are producing so we don't run into this problem. >> let me ask you this. october 20th of last year a whistleblower sent a 34 page report to the fda describing in detail how the equipment in the manufacturing plant in michigan, quote, was failing and in need of repair and that the company knew that this was a problem for at least five years. according to the report, they falsified efforts to cover up the deficiencies of the plant improperly trained employees and successfully hid health and safety risks from fda auditors in 2019 and even though the report was submitted to the agency last october, fda did not interview the whistleblower until late december.
my question is during the same period of time, they saw a 7 billion-dollar increase in its profits and its ceo. if a company lies to the fda about its safety situation at the same time it does massive stock buybacks you simply cannot lie to a government agency. >> the whistleblower's complaint was received and the usual staff reviewed it and did the interview. it wasn't escalated to the leaders of the fda responsible and that was in error that has now been rectified in terms of process. in terms of the status of the
whistleblower complaint, i am not in a position to comment on whether they may be legal proceedings. >> i'm not even asking about the whistleblower complaint. if a major corporation lies to the fda about something as terribly important as the safety of infant formula, what are you going to do? at the same time, billions in stock buybacks, compensation packages is the government, is the agency going to -- it's more important to protect the babies of this country than to give huge compensation packages to your ceos. are you going to stand up to them? >> we are standing up to them and i'm not in the position to say whether criminal proceedings are underway or not. >> is that something in consideration? >> i'm just not in the position to comment. >> i would hope that manufacturers of baby formula which is so terribly important
to parents and obviously the babies understand we cannot lie to the food and drug administration and i hope you are strong about that. >> as you know i've worked on all sides of this and everyone understands when you light of the fda and get caught, there's going to be big trouble. >> i hope there will be. >> like many of my colleagues, i've heard from desperate parents all over the state of maine particularly those that need specialty hypoallergenic formula to support their babies. one of family from sydney, mena, for example, contacted my office after the mother had been spending two months making a round-trip of two hours just to get formula for her baby from her babies pediatric specialist.
that is not sustainable. why wasn't there better communication with parents right from the beginning? why did it take so long for fda to start being public about this very serious problem? >> well, i guess my best answer to that is we were monitoring the supply up until about a month ago. there were issues but they were manageable for the vast majority of people. then things turned to empty shelves very quickly and that's when we really ramped up the public communication. if there were concerns if there was a lot of public communication before that when things were manageable, that it would be understandable that families might purchase more than they needed to be safe, which as i've already said i'm not blaming them. that would be a normal response
that we have seen in other areas with the pandemic. and so, that is basically the situation. >> i think it would have been better if fda had done what you said, which is put limits on how much could be purchased then more forthright with the parents who are really desperate. i want to follow up with press reports that indicate that the senior levels of fda did not receive the alarming whistleblowers report due to the, quote, mailroom issues. you blamed covid-19 staffing issues for preventing the leadership from receiving direct copies of the whistleblower report despite the fact that fda's district office in detroit received a hard copy from a confidential informant way back
on october the october 206th. inexplicably and took four months for that report to receive the attention and get to the senior fda leadership in mid february. let's look at what happened. by that time one infant had already died and two others were hospitalized and the nationwide out of stock rate for infant formula had risen to 26%. i understand the copy that was sent to the van acting commissioner still has not been located to this day. what exactly do you mean by staffing issues? are you telling us fda still doesn't have people back to work in the mailroom and other portions of your agency?
>> let me be clear about two things. the hard copies of the document didn't get to the leaders for the reasons you just gave but there is the escalation procedures because of the people on the staff did get it and they were dealing with it and there wasn't a procedure in place for them to inform the leaders who should have seen it neither the center director or the head of the office of policy response nor the head of the or a. i dealt with this in hospitals and quality systems where nurses were not reporting. for example, we fixed it and we've essentially had to do the same thing. so i'm not blaming the mailroom, but there definitely are problems in the mailroom. this is in fda staff, these are
contractors. >> the productivity of the staff. >> excuse me for interrupting. but i think back to work at their offices in the mailroom. i'm not talking about remote work. back to work. >> for the jobs that require being on site. they are mostly on the road and the reviewers are reviewing documents using computers. they would have been back to where they would be working pre- pandemic. >> i look forward to discussing
that. from silicon valley it's very clear it's much more efficient working in a hybrid situation in the office some. >> senator casey. >> in pittsburgh pennsylvania and had a chance to listen directly to parents talk about their experiences with this infant formula crisis. there is no wonder for the record because this is the reality for so many families. the father's first name is manuel. he's got $3.1 of the three daughters has complex medical needs. she depends on a combination of
nutrition and formula not having the right formula means two things. he said she's stable this week but we live in fear not knowing if we have enough of the right formula next week or every week and went on to describe the challenges they face. so you and everyone in this room has heard some version of those stories. when others have pointed to the timeline between your testimony september 20th when the fda learned of the infection at the sturgis plant that time lagged and other actions were taken you haven't provided a good answer
for that and they need to be held accountable for that among other things. the chair man of the board and the chief executor of abbott and abbott park illinois this is a february 204th letter from the chair man of a senate committee of health education labor pensions committee, senator murray and we haven't gotten the information that we asked for. they've gotten some but it's totally in terms of the response and inadequate especially in light of the findings that you have in your testimony on page two about the evidence of contamination. so, this is a contamination problem for sure. it's also a notification problem
but also what the company didn't do. so i've got legislation to impose obligations. one is to require manufacturers to provide timely notification of circumstances that are known to the company they're likely ty to lead to a disruption of supply chain. the fda also needs to expand and accelerate these notification requirements. to request records in advance. my question is this. talk about those authorities that you would need to oversee the infant formula supply chain. what's the authority now, the
blind spots of the defects that we should fix by way of legislation? >> we have almost no authority than to review the products as they come in and when it comes to this sort of issue there is no requirement when they have an impending shortage. there's no requirement if they find a contaminant in a sample in their facility that hasn't yet been shipped out that they need to let us know that happened in this case the contaminants identified that they didn't notify us about they are required to have a backup contingency plan which i thought was in every industry i've been there is always a plan for what if the plant goes down. you have reports i think three different reports.
there is no central switch to look and see the stress test of what would happen if a plan went out here. is there somewhere else that could do it and the idea of the individual company or 40% of the market share doesn't have a backup plan was inconceivable especially with a history of feeling like it was a reliable product maker for me and my profession. it's upsetting and disappointing but we need authorities to have that kind of information when we have to ask and big companies to give us the information about the supply chain and they don't have to give it every little bit takes a long time. >> you've got to up your game and you can't allow that
timeframe from when the inspection is done so that you can act on it. >> you said we didn't have a good response. i think we have a thorough response. it's just not a good. it was slow and there were errors made. i want to be clear that we acknowledge it. >> senator cassidy. >> i'm sorry we are having to have such hearings. i think it demonstrates better than the paper the issue. the summer before this began or a summer ago there was an 8% increase and it was increasing prior to this latest episode and this is when abbott was closed. so it seems as if there was something happening here. now there's a political article from may 9th and i will quote one of the takeaways was the
food division has structural and leadership problems aside from the lack of attention enough food at the top, unique problems in the center for food safety and applied nutrition a deep-seated culture of hard decisions and a near paralyzing fear of picking serious fights in the industry then it describes a power struggle between the top two officials further strengthening the status quo. to follow up on the comment, zuma can work if people are actually communicating. but if there is a silence between the two. i'm gathering from your answer that these two top leaders were probably zooming they were not in the office and that the chief lieutenants were probably and they were not in the office, is
all of that correct? islam as you and i know, and i don't mean to be insulting, it could be one day a year, a month or a week. do you have the sense of what islam is? >> it depends on the individual that you talk about. between the two it is most likely implicated in how and how frequently were they in the office? >> i don't have the data on that. it could take time for such a report to be done.
we know hhs stayed shut down for longer than the private sector. how many inspectors -- hold this up once more. we had a problem as summer ago. how many inspectors were actually not in the field working and i talk about the specific december function where there was covid at the plant. but just in general, how many were zooming the inspections as opposed to actually showing up for work? ..
>> i accept that. inspecting on site is different. >> i agree. >> i don't mean to be rude. canada, new zealand, uk all speak a form of language. have we attempted to import from there from non-fda inspected facilities knowing that getting fda inspection can be prolonged, difficult, timely et cetera. have we attempted to alleviate the standard similar to ours? >> the short answer is, yes. >> i am told for that to occur there is a 90 day -- >> that is not correct. >> if someone says i have formula, it meets our standards, you can fly it in.
>> we can document most of what needs to be done without doing a hand on inspection. >> let me finish one more thing. are we actually importing non-fda inspected facilities in english-speaking labeled countries? >> we are looking at those applications. it is likely that we will. reciprocal inspections. >> do you have a timeline of when that may begin? it is an agency described as dysfunctional could be months from now. >> every day you will see a new one come on board. >> thank you. >> senator. >> thank you, madam chair. like all of my colleagues here, i am hearing from my constituents. they have shared their struggles
to get formula for their infants. formula for many, if not most of these babies is a matter of life and death. their parents are desperate and terrified. i have called on the administration to invoke the defense production act and allow the importation of additional formulas. i am encouraged that the administration has taken these actions. shortages continue and infants remain at risk. when can new hampshire families expect the shortages to and speared how quickly will they be able to walk into a story be confident they can find formula on a shelf? >> i cannot be exact about this. within two months we should be beyond normal and with a plethora. the shortage will be better and better.
you also see big focuses on the specialty formulas. it is the first thing to come off the line because there was such a dominant country, in that regard it they been able to move their timeline up within a month they will have that specialty formula out. >> does the fda have a plan and a timeline that shows how you get to that .2 months from now? >> this is across hhs. there are many contingencies. there is a committee that has all of the data in hand. if you would like something a little more specific, i am sure that we can produce that. >> i am sure it would be very helpful to get an actual plan. without a plan, without goals, it is hard to know that you will meet them. it is important for the public
to understand when they can have a little bit more peace of mind as they search for formula. let me go to the issue of the specialty formula and the operation fly formula that president biden announced. he announced that we are now using department of defense planes to pick up overseas formula and deliver it to the areas in need. at least two of these flights have arrived carrying several tons of florida. how is the administration prioritizing the distribution of the imported formula to rural areas in other regions. >> each application has to include a distribution plan which is reviewed at the level of hhs to make sure that the most needy places are getting the formula. i can assure you there is hyper awareness of the problems in rural america right now with health in general and access to
care. that is one of the priority areas. >> i would look to follow up on that as well. i just want to turn to thinking through what we need to do once this is over. the fda and other agencies need to take steps to make sure that it never happens again. it made clear the need to build out domestic capacity, manufacture critical goods quickly. what steps should fda and other agencies take to prevent the shortages going forward? for instance, should the administration work to build out extra manufacturing capacity, stockpiled the ingredients needed require manufacturers to reserve a formula or the capacity to make the ones we face right now.
>> we have a number before you right now. those are enumerated. they have not yet decided what we need to do to make a decision on top of this crisis. there has been no stockpile of infant formula. it is something we really need to consider. if we had diversification some federal agency, whether it is fda or some other federal agent the had insight into the supply chains and how they fit together. the likelihood we would need the stockpile would be low. it was resilient to stress. we don't have that now. between stockpiling and having a resilient system, we should be able to prevent this from happening again. >> we certainly need to.
>> thank you very much. thank you for being here today. >> my name gets mispronounced. >> 18,000 staff members. how many of those are back working full time? >> they are all working full time. >> back in the office. >> i am just asking. a lot of people working from home. how many of these employees that you have been relieved of duty because of this? >> 18,000. >> you know, i have been involved in running a lot of successful organizations. firing is not necessarily the
solution to a problem like this. >> people have died from this. people have died from this. >> kids have definitely died but i do not believe there is a direct link that is been proven. >> everyone in your office -- >> we are clear that that is not the case. we are doing the review and putting systems in place. reviewing individual decisions. yesterday, you suggested it may be weeks. where are we at with that? >> as i just reviewed, it will be a gradual improvement up to two months before the shelves are complete again.
>> you are in damage control. what will they do to support public confidence? in the days ahead. >> well, one of the main lessons of the pandemic was shortages. that is the only thing that will restore confidence as having adequate formula on the shelves. we are fully aware of that. we are not letting unsafe products on the market. >> i understand that. how do we get that out to the consumer that by this? >> constant communication. >> do you have a marketing department? is there anything that consists of that? >> we have a very hard-working external relations group and communications group. >> who is your direct person
under you that is overseeing this? the number one person you call every morning, what do we need to deal, where we at? >> the person is handing out the incident managers. the person running the center is susan mayne. we all meet together along with our teams twice a day to review what is happening and make sure we have working orders for the day and for the evening. >> working on this one specific that you directly work with. >> dozens. >> and you meet every day, talk about it two or three times a day? >> yes. if you just take the formula that we discussed, this may be an answer where you have to have whatever specialist, nutritionist and a regulatory network to make sure the end think it's the right formula.
it is a lot of people. >> thank you, madam chair. >> senator smith. >> welcome. the minnesota department of health was the first to link the foodborne illness to the powdered infant formula manufactured at the abbott nutrition facility in sturgis michigan in september 2021. in forming the cdc and fda about that in september. a minnesota baby survived but was hospitalized for 32 days. the fda did not initiate an inspection of the facility until january 21 which led to the voluntary recall and the shortage. my question is how they coordinate with local health departments and foodborne illnesses.
the minnesota department of health, is that the standard process? what can you tell us about what is that link between state health departments in the fda is and what it should be? >> it is really important. there is an investigation lodged and it's very intensive. you have to get to the site, you have to get the cultures, if they are available. often you need to review the medical records. the minnesota health department did a splendid job. the problem is that it was one case and it was positive. found in up to 15% of sponges and kitchens at home. it is a ubiquitous organism that is not necessary. that case was very well
documented. >> wasn't linked to the formulas >> the infant had ingested that formula. it was a matter of concern. >> i also point out it is not a reportable organism. we have banks now what dna sequencing. if we look at the peanut butter case that just occurred, that was all within days. we were able to link the genetics of the peanut butter and the sickness of the people, the genetics that were in the infections in those people. we had the information. i think that we need to do something because it is a well-known, although in frequent cause of contaminant of infant formula. >> are you saying that the length of time that it took firm when that department of health issued, provided this
information and when the fda ended up with the recall happening, is that as long as it should be according to the way the policies work? there is something in that. >> i am trying to give and nuance. the minnesota department of health did its job and what it should have done. you have a direct link that proves that the product actually cause the problem. usually we get a cluster as is happened in peanut butter which happened at the same time and it's easy to make the same case. we had the information we had to wait and see what happens. as i said in my document, it was too long. we are clear about that in my documentation. we have to fix it. >> let me ask you about something else. this is about coordination with usda which is responsible, you
know for purchasing half of the infant formula in the wic program. my understanding is the fda did not communicate with the usda until around the time of the recall. i am wondering if it should be working more closely with the usda sooner and whether you see this as an area that could have improvement. >> let me divide this into two tranches. a lot a communication fda and usda on the general supply chain related to infant formula. it was not about the specific case. even the leaders did not get the information until february 9 about what was going on. that was an escalation error and we have documented that and are fixing that as a systemic quality problem within the fda. as you said, the recall happened right after that. we were in a detailed discussion
with u.s. da. there is a better supply chain, a group of supply chain committees throughout the pandemic. it has been covered by the relevant agencies including usda >> i understand that you have only been at the fda for a short time. i think that you have a unique capacity. because of your industry connection, to be a reformer and diane struck as i listen to you today about how you have been explaining what happens in regards to this supply issue as well as the health issues rather than taking the posture of a reformer which i think is what we definitely need. you have a unique capacity to be that reformer. i believe that this is infant formula crisis as a system. a broader systemic with the food safety in the division at fda.
i urge you to adopt that reforming posture as we move forward. >> as we discussed in the hearing, i do consider myself to be a reformer care. i know that i've gotten multiple phone calls. i sell the problems on the food side of the fda. it is been massively underfunded. what i gam appearing to be may be defensive about is i do not think that it is the appropriate approach in the organization. have a carefully thought out plan going forward. the decisions that were made with working with people to understand what is going done. if you take these employees and castlegate in them in an
organization that is already under stress, i don't think that's a way to fix an organization. it is been involved in many such organizations. if i am not a reformer, i don't know. i was not planning to come back. >> senator marshall. >> i appreciate it. welcome. it takes a lot of guts to come here and face the situation. we appreciate you being here in person. we both know that no matter what happens in the or, delivery room or the er, we are responsible for it despite what the people dead. we feel that sense of responsibility and i'm sure that you do, too. i want to start just by reading a couple of statements. this is stacy from newton kansas. i have a five -month-old
grandson and another on the way. the shelves are empty and newton kansas and the surrounding areas. please help. they should be top priority. and from wichita. this is unacceptable in america. how we let this get to this point? no parent should be worried about this. the empty shelves is what i expect to find in cuba not which wichita, kansas. >> to the point person was for the formula shortage. she had no idea who the point person was. may god help the babies. the shelves and stores are empty. how are we supposed to feed our babies. i believe they need to step in and get answers to the public and get this resolved. katie from manhattan. no room for bureaucracy. lisa from seneca. i am an expectant mother due in
june. i'm terrified i will not be able to find formula for my newborn. we already have to worry about gas prices inflation. i don't need anything else to worry about. >> what would you suggest i tell these moms, grandmom's? >> well, first of all, we are physicians and a physician in a hospital or healthcare system is captain of the ship and takes accountability. that is why i am here. we are sorry we are in the situation and we are working night and day to try to fix it at this point. we know that there will be further inconvenience. beyond inconvenience in terms of desperation that parents feel. they all should should contact us because we are dedicated what we care about an individual case to fix it and make sure that everyone does get access to the formula that they need. >> thank you.
i do want to submit for the record a letter that they sent to you. i think that it was signed by 21 senators so we will submit this for the record. >> without objection. >> next i just want to point out from an action standpoint, what has the fda, what has the white house done to correct this problem? we are breaking of a shipment of 78 million pounds or ounces of formula. that is probably enough formula to feed the babies in kansas for three or four days. >> how much of the problem could have been solved if people were working from home in the fda? if they would have been examining what was going on in the laboratory or possibly over to europe and certified some of
the manufacturing lands in europe that abbott has. we were all expected to work, people had vaccinations. there was every reason i think to go in there sooner. i think the follow-up question is the fda still working from home, our people engage now? >> you are not just a doctor, you are an ob/gyn dr.. that has special responsibilities. i know. but it is also the case in most of the jobs that fda, people are working 100% of the time or more and i just remind you that i come from, and my last job, one of the most successful companies on the face of the earth are people working from home are more productive than ever. i really do not agree with the contention that the work from home policies at fda had
anything to do with the outcome here. i am also not saying that the outcome was a good outcome. i do not want to be misinterpreted. i think the right solution going forward will be a hybrid arrangement. most of the industry is going to if you have jobs with the lab that require you to be there, you've got to be there. you can do that from home just demonstrate that you are doing the work. >> a quick comment. i think that this is a great opportunity for us to encourage breast-feeding. mom's thinking about weaning their babies today, tomorrow, next week, this is one more reason to try to breast-feed a little more a little extra. by the way, it's healthier for your families. >> i am totally in support. i forgot what i was going to say
we do have a history on the importation front. very tragic outcomes with formula. imported formula not that many years ago. that's the reason we have to be careful in making sure that we are reviewing these documents. >> thank you. i want to thank the ranking member for holding this important hearing. commissioner caleb for joining to share your insight and answer these tough questions. thank you for being here. i, like many come from rural parts of america. that is where my question begins in rural regions of new mexico, picking up the formula needed to feed our infants is not as easy as going a few blocks to the closest grocery store. they have to be able to have infant formula. when essentials are not
available, it is not merely an inconvenience but a crisis living in rural communities. on april 12 they released a statement saying that the agency is compiling data on dates of national and regional levels to help understand whether the right amount of infant formula is available in the right locations. if not, where it should go. my question is this. is this equipped to track the availability of formula in rural and tribal communities, some of which don't have access to broadband. >> thank you, senator. it is good to see you back. looking good, too. what i would say is that the system is better than anything we've had before. we have no funding. we took money from other things. i want to emphasize again means
that other things are not getting done. we built a system that does give us some data, but not the data that we would really like to have down to the level of the individual location. soon there will be broadband in every community thanks to the good work you all did to get the bills passed. but we don't have that now. we are following at the granular level now that we can. as i made the point, it has very detailed data about where the products are going. we have no right to compel the industry to give it to us and no right to demand an increase in production until the president put in place a defense production act. the answer would be, yes. we have a system. it is nowhere near what we need. >> i hope that everyone listening to that and the staff that we have here, making sure the tools are in place. incorporating rural communities
as well. we have work to do there as well, sir. >> i've written a number of academic rural health. life expectancy in rural america we need to pay attention. >> we need and appreciate that reminder. preventing wildfires in our state history. homes, cars and livelihood. they are struggling to source a formula they need to meet the nutritional needs of children. how is it taking it into account as they revise on the distribution of formula? >> thank you for that question. having lived in san francisco the last few years, it is hard to appreciate unless you see the size of these fires that we are
now experiencing. part of what we do, it involves, it is an all of government effort. they are constantly getting reports of where the shortages are and directing product to those shortages. any area experiencing a shortage where people cannot get around, please get in contact to make sure that they are aware of it. >> that is a good reminder to reach out to the secretary as well. i reminded them that this fire was started by the u.s. government. it was a controlled burn started by the forest service. we just want to make sure that there is a tension on this one. the other questions that i have, i will submit them into the record. i'm hoping we can do more non-english legislation.
in most areas across the federal government we are still failing in that area. especially with educating families to earn their trust back. these are safe products, this is how you can get them and this is how you do it. >> that is a good example, by the way. the labeling issues that we import. a lot of logistics that have to be coordinated. thank you. >> i yield back. thank you, chairman. >> there has been some discussion about whether the abbott plant was not close soon enough where it was closed prematurely or closed too long. there is no definitive evidence that the children died, the bacteria came from the formula? >> that is correct. i think that it is important. as the investigation went on, the unopened samples from the household did not have any of the bacteria.
the corona bacteria can come from that but it can also come from the home environment. when they do their investigation i know they go back to the plant and take swabs everywhere. do they also take swabs in the home area? >> i would have to check to see if that happens every time. if there is a suspicion. >> we want to prevent it from happening again. it would be nobody's fault. it matched the strain. it does not match the bacteria that killed the children. on the issue of formula, how is european formula different than american formula? why do we prohibit it from coming into the u.s.?
>> we never prohibit it from coming into the u.s. there are 30 nutrients that need to be in a specified label and a specified amount. we just need to make sure that they are correct. they have plans in europe and mexico that have been importing all along. >> are we waiving any of the requirements to fix a shortage? >> we are not waiving the labeling requirements at our time consumed and right. >> when you say we don't prohibit it, you are right, it's not law, but there are a lot of restrictions that deal effectively prohibit it. do you think maybe it would be a good idea to maybe permanently get rid of some of these requirements that are keeping european or japanese formula out of our market?
>> i disagree that that is what is keeping them out of the market. we will continue to look at the labeling. mixing up the formula can be devastating to an infant. >> i think that they have the same concerns. getting back to the same questions of whether we trust international standards on things and whether we don't. i think that it is part of it. how much consider there is an outbreak of iron deficient in europe. i would say that they could be honest expert differences on what formula should hold the would you agree?
>> yes, doctor paul. i am a huge advocate of global coordination for the reason that you gave. we are all human beings. where the requirement is good, we should take that into account it makes it possible to do this, but we are not there yet having more competition. if you do have a problem i'm not sure if it should be shut down for so long. i think that there is nothing wrong with the european formula. there's probably nothing wrong with the japanese or new zealand. there does need to be more coordination. i think that right now it is completely safe and people ought to get the choice of where they buy it from. and the united stas
fine in the previous administration. canadian and mexican formula. those are economic barriers to it. we have to look at the whole picture. i think probably too long since there is no proof that they were actually related to abbott. i think that the overreaction in some ways to the link and not really following the science has led to a lot of this. the economic barriers of tariffs , but also zealous regulatory environment as far as what goes into it. nobody wants dangerous formula but nobody also believes that the european union is, you know, delivering millions of babies in europe. i think that there does need to be more international acceptance of things. i think that you are doing some of that and i commend you for doing it but you are evading your own regulations right now.
these regulations don't make any sense. i think that we should buy legislation address the needs of formula and see if there is a dispute. i bet we could bring in a whole panel of scientists that agree it is just as good or better. it would be a dispute and there are probably hundreds of papers written back and forth on what it should be. another reason why we should not have anyone dispensing what truth is because truth is debatable and people look back and forth and actually have opinions as to what the truth is. i think that we need to be more open minded as far this goes but i do commend you to get out to get more formula in. inappropriately of time that abbott was closed down given that the evidence does not say that the bacteria came from the plant. >> madam chair, can i make two quick points on that. those that argue that on shoring is a solution to all of our problems with our supply chains, this is a classic example of why
that is not the case. the industry could not produce what people needed. on the abbott plan, now that abbott is taking into account their own failings, i think that they would agree completely with us. they are not ready to open. they have known for three months that we would go through this court proceeding, gaining control of their quality system. they have been working on it all along. they had to replace the roof, replace the floors. they still are not done. we went over it when the ceo. hundreds of things that they had to fix. you just cannot open a plant with bacteria growing in it. would you going to kitchen next door if there is bacteria all over the place and people coming through with mud on their feet which is essentially what the
inspection showed? i do agree with some of the main points you made, senator. on those two, i wanted to make sure that my feelings were at least known. >> thank you. >> yes. thank you, doctor. it's great to have you back. i appreciate your willingness. not to subject yourself to this, but for your service. i was going to try to catch senator paul before he left. i thought it was unique the first time i heard him make upon like that. getting to an ironclad solution. somehow that got passed over. obviously, the grief that we feel, it is only compounded this week after what is happened and you've all the. these are circumstances and situations we wish we could
repair. trying to go back to the process and see where the mistakes were made. how do you build back a better structure so that we catch, the next time we catch it sooner. or avoided completely. your comment on how to reform an agency made my heart sink because that is exactly what you have to do. you have to look at the culture. now they have been underfunded. shortstaffed. they have got to believe in their future. i think that you understand that or will move forward. back to the supply chain management, we continue to react to supply change interruptions rather than proactively plan ahead which i think is your inclination to intervene and for us to prevent them. does the fda have adequate access to the critical supply chain information that you need? not the current formula
shortage, but to help minimize the risk of similar shortages of other life sustaining products? >> if i could just take 30 seconds to go on about this. i am a huge advocate of free enterprise and of the individual companies making their decisions that are in their interest to work great for america. what is happened is each company has its own supply chain, its own optimization and when someone says if company acts gets in trouble, will we have a supply for that community? on the dark side we just got authority to require that companies notify us on that shortage. we had over 300 last year that we had to help with. if you talk to hospitals and health systems around the country, they are every day dealing with significant shortages. i will refer you to 60 minutes last sunday. yet for food, we have no authority to compel companies to
give us the information. we even have to pay for it very often to get it. it just seems ridiculous. they have information, there is no reason it could not be transferred. there is no reason that the governor could not intervene. >> that is something we might be able to help you with, i suspect this is just a continuation of that thought. at the federal level. supporting platforms forward. analyze supply chain data. >> i really appreciate that question. i have to be careful. i keep saying, i just want to say it over and over. very hard-working people. not people sitting at home, you know, lounging around. these are hard-working people. anyone that has been involved in
the technology industry knows that you have to update your systems. companies have capital budgets. you run companies and you put it in the capital equipment and that is an expense that you take. we are sure we are doing the best that we can with gum and chicken wire to put things together. ultimately, there will be a reckoning in the federal government. i would also point the cms is a group that needs help with then we are doing a lot of work. on the food side we just need fundamental funding and technology to enable us to do our work. imagine an fda inspector armed with the kind of equipment i saw like google, how much more efficient they would be in getting their job done. they are not handing their data into an old computer. >> at some point we did an infrastructure bill that sent those bipartisan and may be one of the next big things we should look at is technological
infrastructure. we are in almost every agency decades behind. i will just lay this out. based on the information you have, maybe i will let you 15 seconds to answer. with the judge's permission. what is the next supply chain crisis for critical food or drugs under the fda? what do you see as the problems? >> we already have one which is contrast media. the opposite of the joint problem that we had here. we had a major manufacturer ge which had its only plant. i don't know all of the details making contrast media in shanghai. when the covid problem had there they shut down. all of a sudden, you know, we have had a number of medical illnesses in congress lately. someone with a heart attack would not be able to get a test. it is just unbelievable.
i could give you a list of dozens where we are precariously , this is just in time, which is very efficient when things work well. very low inventory, that is an efficient way to run a company. when something goes wrong, if it not a critical supply you need for help okay, you don't have tennis shoes for a couple weeks. you make up for it. >> i'm going to interrupt. >> thank you, chair. that is a really important hearing. i watch this hearing all morning, frankly. who should be to blame for what did not happen? the one think that i think americans really are not interested in are watching them point fingers at the other side. the fact of the matter is the average person in this country is not as interested as we are
to figure out how to make a republican responsible for what happened or democrat to be responsible for what happened to the private sector to be responsible for what happened. this seems to be an all hands on deck. or did not do enough of what they should have been doing. from my perspective, the truth of the matter is, it is pretty frustrating for the average person. in our country, sitting at home watching a crime wave that they have not seen in decades looking at the price of gas at the pump and they are scratching their heads and digging into their pockets and coming up short, a . month in and month out. they see the absolute crisis of inflation that is weighing on their shoulders and the inability to meet the needs that they were able to meet just 18 months ago. finally, mothers, fathers, new
kids, they see this shortage of formula that seems to exasperate their situation in such a way that they simply cannot imagine it happening here at home in america. doctor caleb, i hope that we spend less time pointing fingers that he was to blame and taking responsibility on how we can make things better. the senator was talking about the rural aspects of his state. i will speak to the rural aspects of our state. the fact of the matter is we played ball against each other. specifically at home we are looking at the crisis and they want solutions, not really the blame game. i hope that we spend a few minutes on how do we make sure that this does not happen again. before we get there, my hometown
of charleston south carolina, we asked for babies in hospitals due to the shortage. because they have had an allergic reaction to the specialized formula. what can we do to accelerate the path that those families have what they need and how can we ensure that this does not happen again. >> to your first question on what we can do, for the specialty formulas, as i reported, we have groups of fda people, pediatrician specialists and critical care who needs every day and talk about each case and try to get the right formula to the baby. in the case of babbitt which was a major manufacturer of these, for the hyper specialized formulas that had no substitutes, we have allowed on a case-by-case basis the formula
to be sent out after careful weighing of the risk and benefit since they were made in an unsanitary plan. what you are describing, it is right to try a different brand which is considered to be interchangeable. when it comes to particular drugs for example, sometimes what looks like the same thing, what has to happen is trial and error. they are specialists involved every day in helping to navigate these. you have great ones. i know the institution well. i am sorry that infants have to be in the hospital. but for that kind of critically dependent infant, it is probably the best place for them to be until we get things back up and running. >> transitioning to the latter part of the question, how do we ensure that this does not happen again. we are 20% shortage, 30% shortage, how do we look back
and learn lessons that we learn in the future. >> we have very different data. he showed the most extreme estimate. our estimates are nowhere near what he had showed. we had a very specific list. some of which are in consideration and upcoming legislation and we are glad to share with you. the big question i think that will have to be addressed is do we create a stock pile as a backup in case something does not work in the future? i do worry, what happens if we get the plan back up there. positive cultures would be one example. i think that we will have to have a surplus. certainly planning on a surplus within a couple months. the question is should we maintain that surplus as a government activity for the foreseeable future. that is a question that we will
all have to discuss together and make a decision he had. >> thank you. thank you for being here. i am aware of the resource constraints that the agency is under. i want to make sure moving forward that the fda has the resources to keep all of us safe. i am not sure that this crisis is a lack of resources. as was indicated earlier, there was an in-depth review on the politico back on april, the food safety not being a high enough priority, a big enough priority at fda. that is part of why we are here.
so the failure to prioritize food safety has put infants at risk. i know that we are hearing examples of what is happening in our home state. i have heard from the children's hospital in wisconsin, families coming to the er because they could not find specialty formulas for their children and they were babies that were hospitalized in wisconsin because they did not have access and enough formula. this is not the first time that we have experienced a recall for a product made at the sturgis facility. correct? >> i think that that is correct. i am aware of a recall that occurred in 2010 and a citation that was issued to the facility in 2019.
>> yes. i have a chart. i had forgotten the exact date. so i apologize. >> in the past decade, given that history, how many inspections did fda conduct at the sturgis plant? given a poor track record, evidenced by the prior citation and recall? >> a series of inspections. leading up to 2019. most of which did not show any major problems. then we had the most recent inspection september 2021. inadequate handwashing, standing water in the facility and several of their infractions. that is a written citation and then the company's responsibility is using its quality systems to fix it.
>> you are already anticipating my next question. before we jump into the september 2021 inspection, would you agree that there is better oversight as it was warranted based on past performance. but especially because of knowing just how critical this plant is for our nation supply of infant formula. >> yes. >> okay. >> so in september of 2021, fda officials entered the sturgis facility and as you indicate found pooled water and they also discovered that the plant had found in a finished powder formula lot from june of 2020.
according to reports, the inspector did not swab for the bacterium during this september 2021 visit. is that true? >> they sampled the product, but not the environment. i think the way that you asked the question, you are correct. >> talking about powdered infant formula being manufactured in a facility with a leaky roof with cracked spray dryers, puddles on the floor in the same manufacturer knowingly disposed of a contaminated product and yet the fda inspectors did not swab for samples. >> at the time the leaky roof was not known. the intent of your question, you are correct. >> thank you, madam chair.
>> thank you, madam chair. i will have to lines of questioning here. one is about the industry itself. i have been a proponent since i've been here since i come from the realm of full competition, transparency, markets that have hundreds of players in them. i know that is not your bailiwick, so to speak, but do you feel comfortable where you have three companies that control 98% of the supply of baby formula and when it comes from the specialty formula, 75% by one company, abbott. is not a good place to be, and how much of that concentration is due to regulations and the involvement of fda along the way. it is kind of a broad question. >> there is a short answer to the first part of your question. no, i am not comfortable.
it's not good for the country to have such an identified four critical product like that that is used by so many people? i do not think that fda regulation is at the basis of that. anyone who meets a criteria within the u.s. or outside the u.s. that wants to import can bring formula into that market. we do not restrict the market and we have no control over the market. >> i think that the just, i want to be on record, that is not a free market. it is a monopoly, theory nearly. that is not only the case in baby formula manufacturing the it is in our agriculture market, broader healthcare market for sure. something has to be done if we will not have issues like this, even if a company does pretty
well, most of the time. i have a question about the wic program. is there peculiarity that we are on. it can only be gotten from one company or in that particular, which i think is about 50% where baby formula goes, is that something that the fda has directed or in my off base? >> it is run by a department of agriculture. completely outside of the fda. >> let's look at the timetable of when it looked like things were headed in the wrong direction. of course we shut down so much of the supply chain, i think in a misguided way along the way, but there were cues, a year ahead when it went up to eight- 10%. senator scott mentioned that it got up to where it was close to 50% not having the right amount
of inventory on shelves. i think that part of that time when this all occurred including the dustup with abbott, doctor woodcock was in charge. is that correct? >> that is correct. >> having you appointed doctor woodcock to be the troubleshooter on this, is she back in the program or working for the fda? >> i think that that would beg the question when you have somebody there when most of the problem occurred about midway through. at least the abbott issue, how it made sense that she would be back in. >> if we make, we did appoint someone oversee to look back at decisions made there. steve solomon who was not working under doctor woodcock in
this capacity. >> let's get back to the answer itself. first of all, vindicated on the particular's, the merits of the issue. they had no contribution to those sicknesses. correct? >> with all due respect, i would not say with certainty. it is so rare to have four cases of corona factor. >> you have not been able to connect the dots. still in the position where there was culpability. why did it take roughly two months after nine-10 months of the formula shortage say we better be on full alert to actually get to the issue itself and then once you seem to have come up with an idea that there was not a connection, at least in the short run analysis that it took another couple of months and then at that time the
shelves were empty to get abbott back in the business to do what they were doing. >> we saw the lack of quality in the system and the lack of accountability for the problems that were there. the justice department had to negotiate a consent degree which is essentially abbott saying, yes, we had all of these problems, here is exactly what we will do to fix them. four legal reasons i cannot discuss the exact detail. it took a little arm wrestling to get to the point where the justice department got abbott to sign the consent degree. .... .... a home state has beent
hard by the current formula shortage as a reduction of at least half of the available supply of recent reports range las vegas as the metro area facing the worst shortage in the nation so the local community organizations in nevada we have three squares the women and children center of the sierra among so many others. they are doing incredible work to get the formula to those who
needed the most but they are stretched so thin so recent actions by the administration we know they've come too late. i know you have addressed some of that but what i'm concerned about here we talked a little bit about the forward 21 program and that's a pilot program to monitor the report on food supply chain disruption of vulnerabilities so what is the status of that and where are we at and i really want an answer before i go to some other issues is there a national phone number parents who can't find formula who can get help. hhs has a website hhs .gov/formula and each of the
manufacturers for instance an infant using a particular formula you can call the hotline's and if there's not an answer or otherwise there's a number you can call for hhs to get help so that would be the most immediate thing to do if there is a problem. you asked about 214. would you like me to comment on that? >> yes please because that may help us going forward with vulnerabilities and supply chain disruptions. >> funding was asked for that. it wasn't a given so we borrowed from other fda programs. we are not where we need to be. there are 220,000 registered food facilities in the united states, so a system that is used for infant formula does her general applicability to the program has got to be a robust system. the kind i'm used to working within the private sector we are making progress but nowhere near
where we need to be. >> i want to follow up on something the senator asked about the distribution of the formula coming in from military slides. how is it being decided to beyond existing supply chain routes. the areas hardest hit like las vegas and other parts of nevada are they being prioritized? >> right now the specialty formulas are the priorities so they are going wherever babies are that need to specialty formula which could be anywhere. i'm not on the supply chain committee which as i think you know is a governmentwide committee guiding us through the hole pandemic. i would say quite successfully considering the problems we had early on. you wouldn't show up in a
general manager and that's got to be taken into account. i do want to talk about staffing because according to the american academy of pediatrics, fda has 13 staff members to regulate and monitor, and no staff assigned to supply chain issues. it is currently still the case have you reassigned the issues for baby formula 21 forward this formula is essential and children can't wait, like you said. >> other things the public would expect but this is a top priority and you know that there is legislation pending that would fund additional people for this purpose that are desperately needed. we have only nine because the
other four we got to the funding a couple of months ago and it's going to take a little while to identify and hire people. so we've had to bring in other people about from other programs. >> i see that my time is up. >> thank you, senator burr. >> thank you, madam chair. i'm not sure that there is a member of congress that's defended the workforce more than the ones in front of you and in the role of the fda. i was amused to see two doctors use the same data to come to two different conclusions. i was shocked that that would happen. i think it happens every day. but here's some of the real beef.
corrective action paper. >> not in adequate corrective action report. i've been on the other end in almost every industry and usually when something hasn't gone right to the company has a particular perspective. it may be a little oriented towards a company not necessarily about it's always an adjudication back and forth. >> it's my understanding that in every case that we tried to fill a nutritional need that abbott has paid for those products, is that an accurate statement? >> i don't deal with the funding but they've made a good-faith effort to cover the cause. i just don't know the details.
>> so, you said earlier that you are not going to throw the mailroom under the bus. i want to be clear and i think we were yesterday there are two issues here one is that something went wrong in the mailroom and the other is we didn't have an escalation policy because the employees who were dealing with the complaint to escalate it to the relevant leaders including all three of the leaders who should have gotten it so i'm not blaming this on the mailroom. either of those message would
have gotten the reports to the proper people. they didn't receive direct isolated failure in the mailroom. >> that's direct copies of the complaints. >> specifically, fedex sent the package that had five people addressed and there were five packages with two different facilities. the part of the fda is often a different part of maryland. the direct copies didn't get to the people. they were actually sitting in the receiving dock. >> that is one statement out of an entire report because through the other aspects of the procedure. >> let's go to budgets because you've been pretty
across-the-board. you have $718 million in emergency money. $11 million from the infant health and 10 million for inspections. how many have we hired as of today? >> i would be glad to get it to you. >> let me end on this. the budget is $1.1 billion. you stated you are putting things together with gum in a wire. i think it was to senator paul or somebody. i think 1.1 billion is a pretty substantial amount of money. the chair man and i, and i
realize i am over my time so i will be brief, the chair man and i are negotiating an extra round so we are extremely close. the fda is before us in the midst of a large failure as an agency since it was created. with more authority, more money, more accountability. so, i'm going to go home and try to think about this as to whether it is time for us to move forward on finishing our user fee negotiations. it may be that finding all the answers to this question is increasingly more important than expediting something that really doesn't have a finality until the end of this year.
madam chair, i work with you as aggressively as i can but i also want to work with you as aggressively as i can to get the answers to the questions that are unanswered today. >> that will end of the hearing today but let me be clear it may not end our focus on this. i asked for it weeks ago and i will not stop pushing until i see it. this is life or death and it simply shouldn't have taken this long. i'm going to keep pushing to get formula on shelves and keep pushing to get answers for parents in washington state like my constituent about how they can get what they need because he did speak with his pediatrician weeks ago and they couldn't even find a sample can.
let me be clear, asking parents to call hhs is not an answer. parents from the tri-city area or anywhere else shouldn't be trying to figure this out for themselves on facebook. this is a national crisis that involves international supply chains as well as nationwide distributors and retailers and it is unacceptable to leave families fending for themselves. parents like this need one simple place, to find information they need and get help. we need one coordinator managing this multifaceted problem in helping parents and hospitals and pediatricians as state officials and everyone to get what they need to figure this out. this should have happened days, months ago. it should have never gotten so out of control. and understand i am ready to work with you or anyone else to fix this but i will not stop
pushing. you, hhs, president biden, abbott, other formula manufacturers to do everything you can to fix this as soon as possible and make sure that this never happens again. with that, for any senators that wish to ask additional questions, they will be due in ten business days, june 10th at 5 p.m. and the committee stands adjourned.
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