Grothman Demands Answers on Baby Formula Crisis
Washington, March 28, 2023 | Kyle Amato (202-225-2476)
(Washington, D.C.) – During today’s House Oversight Committee’s Subcommittee on Health Care and Financial Services hearing, Congressman Grothman questioned former U.S. Food and Drug Administration (FDA) officials on the failures within the Department that led to the nationwide shortage of baby formula.
The bulk of Grothman’s questioning focused on Mr. Frank Yiannis, a renowned food safety expert who served as FDA Deputy Commissioner for Food Policy and Response from 2018 – 2023. Grothman pressed Mr. Yiannis on the root causes of the shortage and how the FDA can prevent a crisis of this magnitude in the future.
· Mr. Frank Yiannis, M.P.H
o Former Deputy Commissioner of the Office of Food Policy and Response, U.S. Food and Drug Administration, 2018 – 2023
· Mr. Peter Lurie, M.D., M.P.H
o President and Executive Director, Center for Science in the Public InterestClick here to view Grothman’s remarks.
Excerpt of Grothman’s questioning
Congressman Grothman: “Currently, what is the structure of the FDA and its food programs?”
Mr. Frank Yiannis: “Currently, the food program is what I call a very distributed and decentralized organization. You have the office of Food Policy and Response within the Commissioner’s office, an office that I led of about 40 people, you have the largest office involving food, The Center for Food Safety and Nutrition, which to this day is led by Dr. Susan Mayne, who recently announced her retirement. You have the field force—"
Grothman: “Would you therefore describe the current structure as decentralized?”
Grothman: “Okay, do you think that is a problem, it being so decentralized, if we have a crisis like we had last year?”
Yiannis: “I do, I think the decentralized and distributed nature of the organization caused information silos, not allowing critical data and information to flow to those who needed it quickly and those who needed it most.”
Grothman: “Did you elevate your concern before the crisis?”
Yiannis: “Yes, sir.”
Grothman: “Okay, but nothing was done about your concern, or...?”
Yiannis: “In the time that I was at the FDA, which was a little bit over four years, I had six different bosses, whether permanent or acting commissioners, it's been a rotating seat and every person that I had reported to has known my concerns.”
Grothman: “Okay, the FDA Commissioner Califf released a restructuring plan for the program, in your opinion, does the restructuring plan do enough to resolve the human foods programs organizational issues?”
Yiannis: “While I do believe Doctor Califf’s plan is well-intentioned, I don't think it will completely solve the issues at hand – I know we are limited on time – number one it's been referred to as a new foods program vision, a vision and strategy are very different than an organizational structure, it's a reorg, you need a strategy first and a structure to support that strategy, that's number one. Number two, I’ll disagree with my colleague here, the proposal doesn't even go so far as previous Deputy Commissioners once had. At one time Previous Deputy Commissioners had oversight over Siftsand, over CVM [Center for Veterinary Medicine], but not ORA [Office of Regulatory Affairs]. This new reorg doesn't even go as far as to what previous Deputy Commissioners had.”
Grothman: “That's shocking. In your opinion, does the FDA, because when I think about the FDA I think of drugs and medical devices, do you think the current culture at the FDA is such that, by focusing on drugs and medical devices, they do that to the detriment of the Food and Safety program?”
Yiannis: “I think the drug program, being as big as it is, the fact that it's supported by user fees, does hinder the foods program and the overall agencies focus on the foods program. As I mentioned, it's a very decentralized organization, something I had not experienced in the private sector, and as such, there are many multiple microcultures within the broader organization and it hinders our ability to create one FDA culture.”
Grothman: “Okay, and do you feel therefore as far as the head of the FDA, because they are focusing on the drugs and all the money that flows there, do they kind of consider food a little bit of an afterthought?”
Yiannis: “My experience and decisions that have been made, including financial ones on supply chain monitoring, food has taken a backseat to drugs.”
Grothman: “Okay, is it appropriate for the FDA to inspect foods in the way they inspect drugs and medical devices?”
Yiannis: “The approach would be slightly different, it's a different food with different risk factors, but we should be inspecting food facilities, for sure.”
Grothman: “In December, the Reagan-Udall Foundation for the FDA conducted an operational evaluation of the FDA’s Human Foods program. Are you familiar with this report?”
Yiannis: “I am.”
Grothman: “Okay, can you get into that a little bit?”
Yiannis: “Sure, the Commissioner and the Principal [Deputy Commissioner], selected the Reagan-Udall because of the close associations with them. I do think they attempted to create a fairly independent report, they provided a series of options for restructuring with the Commissioner having the latitude to choose those different options. One of the things are really liked in their report is that they emphasized culture, you can't fix FDA or strengthen FDA by just doing a reorg, you also have to address cultural issues.”
Grothman: “Okay, and do you think to a certain extent that it would be addressed if we separated the human foods and drugs division? That could force maybe a stronger culture?”
Yiannis: “I think that could be a factor that could contribute to a stronger one food program structure, there are other ways to do it as well.”
Grothman: “Okay, thank you.”
U.S. Rep. Glenn Grothman (R-Glenbeulah) is serving his fifth term representing Wisconsin’s 6th Congressional District in the U.S. House of Representatives.