The question members of a Senate subcommittee wanted answered by FDA officials involved how to make food safety a priority at the agency. The FDA commissioner said much of the answer would come out when a “top to bottom” review of the agency has been completed.
During a hearing Wednesday, members of the Senate Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies most of the questions from senators came in the context of knowing that the Food and Drug Administration could use some more money. Most of the senators said that goes without saying. FDA Commissioner Robert Califf agreed. The lion’s share of the agency’s funding goes to the so-called drug side of the FDA.
But those on the Senate panel wanted to know what besides money is needed.
“Is food safety a priority at the FDA?” asked subcommittee chair Sen. Tammy Baldwin in her opening remarks. “The easy answer is funding, but that is not the only answer.”
The FDA commissioner assured the senator that food safety is a priority for him and said he anticipates a future where food safety is better. He also said the agency has good staff but they need more resources. More staff is also needed and is one of his priorities.
Commissioner Califf pointed to the review of the agency that he announced on Tuesday, which will be done by the Reagan Udall Foundation, an external entity with ties to the FDA. He said he expects the review will identify multiple issues in addition to funding.
Throughout the hearing with the FDA panel one question was glaringly absent — would the FDA be better served if the position of deputy commissioner was reintroduced. The senators did not bring up the question, neither did the four administrators from the FDA.
Following the first panel senators turned their attention to consumer and industry leaders. Brian Ronholm, Director for Food Policy at Consumer Reports, and Sarah Gallo, Vice President for Product Policy at the Consumer Brands Association were in the witness chairs.
Both Ronholm and Gallo opened their testimony with a call for the deputy commissioner post to be reinstated. They said without it the FDA has been working in a fragmented manner without a clear chain of command.
Currently the FDA has two food safety administrators who report directly to the commissioner: Frank Yiannas, Deputy Commissioner for Food Policy and Response and Susan, T. Mayne, Director for the Center for Food Safety and Applied Nutrition (CFSAN).
When the agency had a deputy commissioner, most recently in the Obama Administration, the CFSAN director and leaders of all other food programs reported to that position.
“The success of the food program requires a single voice,” said Ronholm. “We are not going to algorithem our way out of the problem.”
Gallo had a similar view. She said a key component to safer food is for the FDA to speak with one voice. Without that it is “hard to connect the dots.”
“The FDA can do it right now,” Gallo said, reminding the senators that creating a deputy commissioner position does not take an act of Congress.
Ronholm said without a deputy commissioner the “food side” of the FDA gets pushed out of the agency’s attention because there are multiple people reporting to the commissioner, creating fragmentation and diluting communication about food safety.
Other questions and answers
In fast paced exchanges with the four FDA administrators the senators on the subcommittee explored a number of topics related to food safety. Here are some of the highlights.
Sen. Jerry Moran, R-KS, asked Commissioner Califf about whether the FDA still has people working from home, which was started at the beginning of the COVID pandemic. The commissioner said about half of the agency staff continues to work from home, but said none of the people who had jobs requiring them to be in the office were ever working from home. He cited lab staff and inspectors as examples. Moran said he wanted to see more people back in their FDA offices saying “you can’t have a team effort without a team there.”
Sen. Baldwin asked FDA’s Yiannas what is needed to make food safety a priority at the agency. He said three things are crucial: 1. Food safety needs to be a culture, not just a priority; 2. There needs to be movement every day toward more modernization; and 3. Very high performance expectations need to be in place.
Sen. Moran asked Califf when the “top to bottom” review would begin. The commissioner said as soon as final arrangements could be made, with a final report planned for 60 business days after the review is completed.
Editor’s note: The Reagan-Udall Foundation for the Food and Drug Administration is a private nonprofit (501c3) organization, created to support the mission of the U.S. Food and Drug Administration to help equip FDA staff with the highest caliber, regulatory science and technology in order to enhance the safety and effectiveness of FDA regulated products.
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