Robert F. Kennedy Jr. has called the Food and Drug Administration a “corrupt system” that is waging “war on public health.” He has pledged to eliminate “entire departments” at the agency charged with ensuring the safety of the foods Americans eat and the medicines we take, warning the more than 18,000 people who work there to “pack your bags.”
President-elect Donald Trumphas nominated Kennedy to lead the U.S. Department of Health and Human Services. If he is confirmed by the Senate, Kennedy will have the opportunity to “go wild” on health, foods and medicines, as Trump put it during the campaign.
Remaking the FDA may not be as straightforward — or as desirable — as it seems from the outside, says Dr. Robert Califf. He’s in a position to know: his second stint as the agency’s commissioner comes to an end Monday.
Food and Drug Administration Commissioner Robert Califf testifies during a Senate hearing on Capitol Hill.
(Jose Luis Magana / Associated Press)
Califf’s career has spanned academia, large health systems, the biotech industry, Silicon Valley and the highest echelons of the federal government. His colleagues at the FDA “work just as hard and are at least as smart” as people he’s worked with anywhere else, he said. Public criticism comes with the territory, but things look different when you’re on the inside trying to ensure access to infant formula, make tobacco products less addictive and help consumers understand what’s in their groceries.
Califf spoke to a group of reporters last week on his last day in the FDA’s White Oak campus in Silver Spring, Md. Here’s his advice to those who will take over public health roles in the incoming Trump administration. His comments have been edited for length and clarity.
What do you wish people understood about your job?
This is a job that has a lot of bosses and a lot of constraints. When you’re in the commissioner’s office at FDA, you report to the executive branch. But Congress also thinks it’s your boss. It’s not unheard of for FDA to want to do something and get a message from an important appropriator that, “If you do this, we’re going to cut your budget somewhere else.”
It’s really interesting to me that people think the FDA can just declare this and that. It usually can’t. It usually has to go through a systematic approach. The minute you step beyond the legal boundaries of what the rule book says, you’re going to end up in court. That will get reined in fairly quickly.
How do you expect the new administration to change the FDA?
I have no idea. Right now we have rhetoric, and the rhetoric is contradictory. We just have to wait and see.
Some of the people who have been nominated to positions have been very critical, implying that there are nefarious motives of people working in public heath agencies. It feels a lot different when you have to make the decision and be accountable for it as opposed to criticizing the decision.
I have a copy of [President Theodore] Roosevelt’s “Man in the Arena” speech above my desk at home to remind myself every day that you get all this criticism from people who are not actually doing the work. It’s better to be in the arena trying to do the best that you can do.
Kennedy says he wants to get rid of certain departments within FDA. Are there areas you’re most worried about?
I’m worried about every part of the FDA. I don’t think you’ll find people at FDA doing work that no one cares about.
If you look at the food side of the FDA and the inspectorate, it’s massively underfunded. If you cut that — especially if you’re also saying we need to radically change the food system — that would be a problem.
Kennedy wants to see big changes in the food and health industries. Is that realistic?
Slogans are easy, and they sound really tough, but it’s a little different when you get into the to-and-fro. The lobbies that have very much created this food system are powerful. Maybe they can be overcome. There’s a possibility that things could be done for public health that couldn’t be done before.
The other part of this is if you really want to change the food system, you’d better have a 10- or 20-year plan. If you pronounced today, “No ultra-processed foods in SNAP or other federally assisted programs,” the farming industry would crash. I’m not saying that’s a reason to keep it the way it is. What I am saying is you’d better have a very carefully thought-out plan which sustains the economy, not just a bunch of slogans.
Trump said he would investigate claims about vaccines and autism. How should the FDA respond?
Anyone that investigates this will find that the risks and benefits are already delineated. There are dozens of studies that show no relationship between vaccination and autism. It wouldn’t be where I would spend my time, but if he wanted to do it, I think he’ll find that things are already well-documented.
That doesn’t mean that post-market surveillance couldn’t be better. It’s not a great way to have things that every time a question needs to be answered for public health, you need to get permission from every state and territory.
But I don’t think people are going to find any surprises. It’s all out there. For there to be any kind of conspiracy, it would take a whole lot of people outside of government deciding to work together. I’ve lived in America my whole life. It’s hard to get anybody to work together on things.
You’ve called misinformation a leading cause of death. Is it getting better or worse?
We’re losing the battle on misinformation. I’m not talking specifically about FDA. I’m talking about all of us.
To me it’s very clear that a lot of people died who would not have died had they just gotten a free COVID vaccine, and had they not been misled or been made to feel doubtful by people peddling incorrect information.
Often people who are experts in one area have opinions about another area, then when someone disagrees they call it misinformation. It’s a lot easier to put out a slogan or to make something up than it is to worry about whether you’ve got it right and take the time and effort to go to sources and get the right information.
We’re losing the battle right now because of this intersection of social media and cultural changes that have happened. It threatens a lot of the basis for public health. We’ve got to create networks of people who are dedicated to the truth.
What advice do you have for the new health leadership?
Change doesn’t come so easily in government. If we move at least five people, it has to get a congressional review. This makes it really hard.
When possible, use evidence for decision-making. I’ve heard a lot of tweets and short social media things saying, “We’re going to do this, we’re going to do that.” Let’s see the evidence about what an effective treatment is, and then if it’s good, go with it.
Those are my two main pieces of advice.