Speculating on a Future for FDA Under President Trump

It is difficult to speculate about how the Food and Drug Administration may emerge under the Trump administration, but for some hints we have gathered some information to imagine the road ahead. Please remember that this is a speculative exercise at best and should not be construed as anything more than that.

On his first day of his confirmation hearing before the Senate Health, Education, Labor and Pensions Committee in early April, the FDA commissioner nominee told lawmakers that he supports the Food Safety Modernization Act.

We now know that Scott Gottlieb, a practicing physician and resident fellow at the American Enterprise Institute, is President Trump’s pick to be the 23rd commissioner of the FDA. According to sources, Gottlieb is one of the nation’s foremost voices for “changing the FDA’s culture.” On his first day of his confirmation hearing before the Senate Health, Education, Labor and Pensions Committee in early April, the FDA commissioner nominee told lawmakers that he supports the Food Safety Modernization Act.

At the nominee’s confirmation hearing Senator Pat Roberts, a panel member who serves as Senate Agriculture chairman, told Gottlieb he’s concerned that the FDA has been focusing too much on “agenda-driven” nutrition policies and not enough on implementing FSMA. Gottlieb’s reply is encouraging for the food industry which recently drafted a letter to congressional leaders asking for a fully budgeted plan that assures the safety of our food supply through complete implementation of FSMA, including enough resources for compliance oversight.

“My mandate is going to be to make sure FSMA is implemented in the proper way, and that we’re striking the right balance with respect to that implementation.”

“I think FSMA was a significant advance in terms of giving the agency the authorities it needed and the resources it needed to ensure the food supply is safe,” Gottlieb replied. “My mandate is going to be to make sure FSMA is implemented in the proper way, and that we’re striking the right balance with respect to that implementation.”

In comments made prior to his nomination as the new FDA Commissioner, he also alluded to wanting a functioning FDA that can provide more timely results which also bodes well for FSMA implementation, though his comments pertained to the drug approval process.

“The FDA’s cumbersome (drug) approval process has been a long time in the making, but its effects are by now clear to patients, physicians, and drug makers, Gottlieb wrote in the journal National Affairs in 2012… One would expect that this growing awareness would prompt lawmakers to seek some remedy, and they have — but legislative fixes will succeed only if they are rooted in a proper understanding of the problem.”

Everything Gottlieb has written will now be considered as part of his Senate confirmation, but his record shows that his experience involves drugs and medical devices not food safety. If confirmed (and he is expected to be confirmed), Gottlieb will succeed Robert Califf, who was FDA Commissioner for almost a year and also favored drug and medical device lines.

Taking a Look at Trump’s Personal Habits and his Proposed Budget for Hints of Direction

As an avid tweeter, we do know that the President has referred to FDA as the “food police;” and mentioned in a leaked phone conversation that he may impose stricter food safety standards for trade purposes. President Trump is a self-described germaphobe and that is reflected in his dining habits: he orders his hamburgers and steaks well done! A noted consumer of fast food meals, he explained in a campaign interview last year that a big fast food franchise can be destroyed with one bad hamburger. Clearly, he comprehends some basic economics of foodborne illness, and the impact it can have on consumers, businesses, and trade.

At first glance, it does not appear that any of the $54 billion President Trump wants to shift to defense from domestic programs will be coming from food safety. The “America First” document released by the White House in fact claims the President’s 2018 Budget “Safeguards the Nation’s supply of meat, poultry, and egg products by fully funding the Food Safety and Inspection Service, which employs more than 8,000 in-plant and other frontline personnel who protect public health in approximately 6,400 federally inspected slaughter and processing establishments nationwide.”

The President is asking for $17.9 billion for the U.S. Department of Agriculture for 2018, a cut of 21 percent or $4.7 billion. It would put the emphasis on food safety, nutrition assistance, and rural community support. The Department of Health and Human Services (HHS) would get a $69 billion budget for 2018, but that in turn is a $15.1 billion or 17.9 percent cut from the 2017 annualized budget level.

The budget document is silent on exactly how much is being requested for FDA’s implementation of the Food Safety Modernization Act.

HHS houses the FDA, which regulates the food not covered by FSIS. The budget document is silent on exactly how much is being requested for FDA’s implementation of the Food Safety Modernization Act.

The Trump budget calls upon FDA to double —to $2 billion—the medical product user fees charged for its reviews of drugs and medical devices. There is no mention of user fees for food safety. However, since it controls the overwhelming majority of food inspections in the U.S. FDA is expected to experience an 18 percent budget reduction. This could put food safety in jeopardy because of less emphasis on inspecting imported foods. This leads to fear of more food recalls, foodborne-related outbreaks and illnesses.

While Congress will have the final say, it would be helpful if the Administration could recognize FDA as an “exception” in the final budget. While FDA stakeholders should be concerned, they should not panic. What the President described is a general proposal, to be fleshed out with more details when he sends his budget outline to Congress in mid-March and his complete budget proposal in late April or May.