A long time ago. The thing that bothers me is we, like some other countries, we follow the law of this country. We go to t embassy, we filed paperwork, we wait years and years and years. Nobdy calls us until you become an american citizen and you challenge the system. The system was to work, they must control every country how much, how many people they can get asylum. We will break away at this point for a house hearing on infant formula supply chains and last years nationwide shortage, fda food safety and nutrition director susan mayne here testifying before the House Oversight subcommittee on health care. Live coverage on cspan 3. First oversight hearing last years infant formula crisis, and during that hearing we heard from former Deputy Commissioner in charge of the office of food policy and response, franky yiannis. Mr. Dianas testimony highlighted many internal failures within the fda that led to the classic to carry out one of the most Critical Missions which is food safety. His testimony also raised questions of why key facts about the crisis were emitted when commissioner caliph and dr. Susan mayne testified before the energy and Commerce Committee last february. In the socalled independent salman report. Todays hearing will continue the long and overdue oversight of the food and drug administrations response to the infant baby formula crisis. We hope to get answers on why the fda has not been fully forthcoming with congress and really the public. Todays hearing will examine why it took more than four months for inspectors to arrive at the facility plant in sturgis, michigan, after babies starting getting sick. We will determine why it took so long for the Biden Administration to secure the baby formula supply, after a recall left its shelves bare. Why was the fda prepared for the crisis . Why did they only inspect three of 23 infant formula manufacturing facilities in 2020 . Three of 23. Why did they fail to investigate whistleblower warnings . Did the fda follow regulatory protocols . Did the fda respond quickly enough . Was the fda socalled independent review truly independent or was it a coverup . Today, i will get answers to these questions to better understand exactly what happened so it doesnt happen again. American families must be confident that the fda has the ability to prevent a crisis like this from ever happening again. In our previous hearings, we learned a lot about how the crisis happened and how it couldve been handled better. From fda officials. Heres what we know so far, to lay it out. The fda ignored habits employees, 38page disclosure detailing concerns at easter just plant. The policies and lax approach to oversight elected unprepared to address the supply Chain Shortages after the sturgis facility was actually shut down. The fda had failed to prioritize food safety. The fda has not taken the action needed to prevent a similar crisis from happening again. The American People paid the fda 6. 7 billion dollars last year. 6. 7. In next years budget, the fda wants over 10 more, totaling 7. 2 billion. I think the American People have a right to know that if you only took a look at three out of 23 and you were paid fully, now we are at a crisis, we dont really have answers to the crisis, yet you want more money. Listen, we all want everyone to be safe and we all want to make sure we are safe, but i think we all also want to make sure our money is going to do good work. So i think the American People deserve to know that if we are going to have these agencies and we are going to spend a lot of money on these agencies, these agencies need to make sure they are doing their job. As opposed to throwing money at the problem. After a field inspectors should have been doing their jobs but they werent, and there were not serious consequences. I have yet to hear what the consequence for the fdas other than, give me more money. They didnt do their job, they sat at home, they still got their paychecks. They want more money, which may help, but what is going to change . Now its time for the current fda leadership to really be held responsible in business there. , stockholders are held responsible, people get fired, and they lose money they lose profits, there is a consequence to the actions. I have yet to hear who is responsible at the fda and what is the consequence for their failure. I think we deserve that, especially for over 6 million worth of money. Here, we will discuss what failures within the fda led to the crisis. We will discuss ways if the fda can improve its internal controls to get ahead of potential disruptions and prevent future supply chains. We will discuss why the fda admitted key facts from the public. We owe it to parents, caregivers, and infants, to get to the bottom of what really happened to fix it. We cant fix a problem that we first cant admit exists. As i said the last, hearing the families of these babies that died from contaminated formula deserve answers on how this tragedy was allowed to occur in the first place and what we can do to prevent it from happening again. Thank you doctor, mayne, for being here today, congratulations on your upcoming miss porter for her opening statement. Thank you very much, madam chairwoman. Today, we are having the second part of our subcommittees hearing series on the 2022 infant formula shortage. So far, the chairwoman and i agree on something really important. And infant formula shortage could repeat itself. Thats a deadly serious problem. Lets think back to a year ago today. 43 of formula products were out of stock across the country. Bacterial contamination abbott, which killed nine babies, made hundreds of others fall ill, prompted a recall that shocked our formula supply chain. That this repression of course interrupted our economy, but more critically threatening the health, nutrition, and lives of our kids, and the American Peoples confidence in government. Today we are saying, on a bipartisan basis, and that it could happen again. We have a duty to do something meaningful about it. And this hearing is called responsibility for the infant formula shortage. As i said last time, there is a lot of blame to go around. Its clear that with todays witness election and that republicans want to blame the fda. I will level with you, i think some of that blame is well placed. Weve had two subsequent input formula recalls in 2023 already, and we are still seeing that the fda can make further improvements on its internal processes, intervene and issue sooner, and follow through with more inspections to prevent further contamination. Other lawmakers will blame manufacturers for their negligence and failure to produce of Safe Products. That is true, to. Still others will blame washington for allowing just three manufacturers to have monopolistic control over 90 of the Formula Market and for failing to invest the resources and authorities in the fda that it needs to produce the results we demand. I think those folks are correct, to. The thing about this issue though is it doesnt come down to the fault of one person or one agency, one company, or one political party. We cant fire or attack someone and expect formula contaminations and shortages to just go away. Thats why today i propose we go beyond the title of this hearing, we need to move beyond just assigning responsibility and toward delivering solutions that can prevent a shortage from happening again. I want to thank the chairwoman for her work with me on that. We need to use these hearings to identify what are worthy proposals, worthy innovations, and we need to transform them into legislation. If we dont do that, we are failing to solve the future problems. We risk just blaming and shaming rather than preventing and problem solving. If we Work Together though we can address the efficiencies and inefficiencies that risk the supply of safe and healthy infant formula. We have an fda expert before as you can help us with that. Look, doctor mayne can handle what we will throw at her. We should ask hard questions. We should push her on areas where we think the fda can and should do better. We should also use in doctor maynes knowledge to figure out what congress should be doing better. Right now, the fda is reorganizing its Human Foods Program to reduce fragmentation and approve coordination. But thats not going to solve all the fundamental issues. Even with the best structure, leadership, and resources, and the fda is only as well equipped and as accountable as Congress Makes it to be. While we hold the fda and others responsible, what can congress be doing to help . First, we have to provide the fda with resources to increase its inspection and food safety capacity. You cant expect an agency to do better when you are taking away the funding for the personnel and technology needed to make it happen. Thats why i think the 22 cut to the fda that republicans have voted for would make this problem worse. Lets not go down the path, that path. We expect the fda to do better. We need to set it up for success and then hold it accountable to deliver on a better outcome. Whether we reach bipartisan consensus on proper funding or not, there are some no cost reforms we should be able to agree on. We need better processes for reporting and tracking contamination, whether that is making nationally notify will disease or making sure all contaminations and critical food factories are promptly and properly reported. If we use dr. Mayne as a resource, we can find solutions we all agree on to save kids and stop shortages. Lets come out of this hearing with next steps, not just complaints about missteps. I yield back. Thank, you miss porter. Now im pleased to introduce our witness, who is here to discuss the fdas response to the 2022 infant formula, baby formula shortage. Dr. Susan mayne it is the director of the center for food safety and applied nutrition at the food and drug administration. Shes been in this role since in january of 2015. A doctor mayne has received a b. A. In chemistry from the university of colorado. Shes also earned a ph. D. In Nutritional Sciences with minors in biochemistry and toxicology from cornell university. Pursuant to rule nine g, the witness will please stand and raise her right hand. Do you solemnly swear or affirm that the testimony you are about to give is the truth, the whole truth, and nothing but the truth, so help you god . Thank you. Let the record show the witness answered in the affirmative. Now we appreciate you being here today. I really do look forward to your testimony. Let me remind the witness that weve read her written statements. It will appear in full in the hearing record. Please limit your oral statements to five minutes. As a reminder, please press the button and the microphone in front of you so that it is on and members can hear you. When you begin to speak, the light in front of you will turn green. After four minutes, that light will be yellow. When the red light comes, on your five minutes has expired. We would ask you please wrap up. For this, i. E. Recognize your opening statement, miss mayne. Chairwoman mcclain, chair comer, ranking more members chair and thank you for inviting me to testify on the safety and supply of infant formula in the united states. As a parent myself, i know nothing is more important than the health and safety of our children, and last years infant formula recall in shortage put a strain on parents and caregivers across the u. S. When we saw the egregious conditions of abbots sturgis facility, we knew a recall could stress an already unstable marketplace. But we had to put our Children Safety first. Fda takes in the situation extremely seriously and has applied many Lessons Learned resulting in greater confidence in infant formula safety. One of the most important lessons we learned is that the agency must do all it can to ensure that no infant formula facility ever has the level of in sanitary conditions and that were present at abbots sturgis in 2022. We have made progress and are using the full extent of our authorities to address the Lessons Learned. Preventing another shortage in the future will require a continued hold of increased industry accountability and cooperation, and help from congress. Today, i would like to talk about the future of infant formula safety and our vision for modern regulatory approach. First, the ultimate responsibility to produce Safe Products is on infant formula manufacturers. We need industry to comply with our requirements and to adopt enhanced food Safety Measures to deliver the safest possible infant formula. Two months ago, we issued a call to action to industry to take specific steps to improve food Safety Practices for the protection of infants. Second, we worked diligently to increase the supply formula on the u. S. Market. And the institute rate for formula is near 90 , which is higher than prerecall levels and exceeds sales week after week. Market consolidation is a serious concern and contributed significantly to shortages, there are currently only three domestic producers of infant formulas, which means international conflict, or Natural Disaster could impact formula supply. Our temporary exercise of Safe Products to enter the u. S. Market, doubling the number of firms producing formula for the u. S. Almost all the manufacturers participating under the Enforcement Discretion policy are taking the necessary steps to stay in the u. S. Market. Federal Agency Partners also have an Important Role in helping to address market consolidation. We will continue to work with him to encourage a stronger, diversified, and more resilient u. S. Infant Formula Market. Third, fda and industry should be able to address product contamination in or near realtime. Our inspections are currently a snapshot in time. More realtime oversight can transform infant formula regulation by ensuring first promptly investigate investigation and destroy adulterated product before it reaches consumers. To do this, we need modern authorities, including explicit authority to require industry to notify us when formula tests positive for corona bachter. Even if the product has not left the facility, and the ability to obtain records remotely from all food manufacturers. Fourth, we continue to advance the science around corona backed, are a very common pathogen in the environment, but one about which we have limited information. Corona bachter infections should be a local state and federal Public Health partners can reliably collect information on all cases and we can rock. We are intent on delivering an empowered unified Human Foods Program and a worldclass field force that will deliver modern, integrated oversight. As part of this will be creating an office of critical foods as required by the food and drug omnibus reform act. We are also actively hiring for specialized infant formula inspection staff that will execute a modern preventive approach to infant formula expect inspections. In the early days of covid, in 2020, and well before the abbott recall in infant formula shortage, we recognized the critical need to better resource our infant formula program. We are grateful for the resources we have received but our Human Foods Programs are still in dire need of additional investments and updates to meet current as well as future challenges. As we emerge from the Public Health emergency, the Food Industry still has fragile supply chains. Preventing shortages will take continued Cooperation Among all the players and additional authorities and resources to modernize our programs. We look forward to working with you all to make this a reality. I welcome any questions you may have. Thank, you doctor mayne. I now recognize mr. Grothman. Thank you. And dr. Mayne, are you familiar with the fdas internal agency review, led by dr. Sullivan . Yes i am. We were interviewed by dr. Solomon in course of the review. I was interviewed by the same group of folks who were interviewing all the people who participated in the interviews, that information was consolidated and put together for dr. Solomon. Why dont you think you were interviewed . Im sorry . Why dont you think he interviewed you . He didnt interview any of the individuals. There were a large number of people who were interviewed and it was consistently done across all the interviewees. Apart from dr. Solomon, did anyone else in the f. D. A or hhs author the report . Im sorry . And apart from dr. Solomon, did anyone at fda or hhs author the report . No, not to my knowledge. Okay. Principal Deputy CommissionerJanet Woodcocks who owned the report. I believe she was one of the individuals who called for the report so we would look internally at our processes and see what changes could be made expeditiously in the spirit of Continuous Improvement. Okay. Was she involved in the report . Other than asking that the report be executed, not to my knowledge. Okay. We received testimony before the subcommittee that implies that she was involved in it. I will give you another chance to answer. The doctor woodcock influence the solomon report in anyway . She asked that the report be conducted. People were interviewed. The data was compiled, produced in her report. She asked about the report be conducted along with commissioner caliph. Okay. Comptroller general jean stated in april, 2023, House Oversight hearing, that the fda is not, quote, not doing enough to improve its Food Security and food safety. Food safety has been on the most highrisk list since 2007. Doctor mayne, do you think the fda is doing enough to ensure food safety . We can always do more to ensure food safety.