Advice to RFK Jr. on how FDA can improve Americans' health


Robert F. Kennedy Jr. has called the Food and Drug Administration a “corrupt system.” “War on Public Health.” He has promised to cut “entire departments” in the agency tasked with ensuring security of the food Americans eat and the medicines we take, and warns the more than 18,000 people who work there to “pack your bags.”

President-elect Donald Trump has named Kennedy to head the U.S. Department of Health and Human Services. If it is him confirmed by the SenateKennedy will have the opportunity to go wild like Trump on health, food and medicine Say it during the campaign.

Redesigning the FDA may not be as easy – or as desirable – as it seems from the outside, says Dr. Robert Califf. He can know: His second term as commissioner of the agency ends on Monday.

Food and Drug Administration Commissioner Robert Califf testifies during a Senate hearing on Capitol Hill.

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, major 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 the people he has worked with elsewhere, he said. Public criticism comes with the territorybut things look different when you try inside Ensuring access to infant formula, make tobacco products less addictive And Help consumers understand this what's in their food.

Califf spoke to a group of reporters last week on his final day at the FDA's White Oak campus in Silver Spring, Maryland. Here's his advice to those who will take on public health roles in the new Trump administration. His comments have been edited for length and clarity.

What do you want people to understand about your job?

This is a job with many bosses and many restrictions. If you are in the FDA Commissioner's Office, you report to the Executive Branch. But Congress also thinks it's your boss. It's not uncommon for the FDA to want to do something and get a message from a key appropriator: “If you do this, we'll cut your budget somewhere else.”

What's really interesting to me is that people think the FDA can just declare this and that. Normally this is not possible. A systematic approach usually needs to be taken. As soon as you exceed the legal limits of the rules, you will end up in court. This will be contained pretty quickly.

How do you think the new administration will change the FDA?

I have no idea. Right now we have rhetoric, and the rhetoric is contradictory. We'll just have to wait and see.

Some of the people nominated for positions were very critical and suggested that there were ulterior motives in working in public health agencies. It feels completely different when you have to make the decision and take responsibility for it instead of criticizing the decision.

I have a copy of (President Theodore) Roosevelt “Man in the Arena” speech. over my desk at home to remind myself every day that you get all this criticism from people who aren't actually doing the work. It's better to be in the arena and try to do the best you can do.

Kennedy says he wants to eliminate certain departments within the FDA. Are there any areas that cause you the most concern?

I worry about every part of the FDA. I don't think there are people at the FDA doing work that no one cares about.

If you look at the FDA and regulatory food side, it is massively underfunded. If you cut that – especially if you also say we need to radically change the food system – that would be a problem.

Kennedy wants to see big changes in the food and healthcare industries. Is that realistic?

slogans are simple and sound really hard, but when you get into the back and forth it's a little different. The lobbies that created this food system are powerful. Maybe they can be overcome. There is a possibility that things could be done for public health that were not possible before.

The other part of this is that if you really want to change the food system, you better have a 10 or 20 year plan. If you said today, “No highly processed foods in.” SNAP or other government-sponsored programs,” the agricultural industry would collapse. I'm not saying that's a reason to leave it as it is. What I'm saying is that you'd better have a very carefully thought out plan that supports the economy, not just a few slogans.

Trump said he would investigate claims about vaccinations and autism. How should the FDA respond?

Anyone who studies this will find that the risks and benefits are already delineated. There are Dozens of studies this show no relationship between Vaccination and autism. I wouldn't spend my time doing it, but if he wanted to do it, I think he would find that things are already well documented.

That doesn't mean that's the case Post-market surveillance couldn't be better. It's not a good way to structure things so that you have to get permission from every state and territory every time a question needs to be answered to protect public health.

But I don't think people will get any surprises. It's all out there. For there to be any kind of conspiracy, many people outside the government would have to decide to cooperate. I have lived in America my whole life. It's hard to get someone to collaborate on things.

They have cited misinformation as a leading cause of death. Will it get better or worse?

We're losing this Fighting misinformation. I'm not talking about the FDA specifically. I'm talking about all of us.

For me that is very clear many people died WHO wouldn't have died they just had receive a free COVID vaccineand would they not have been misled or doubted by people spreading false information?

Often, experts in one field have an opinion about another field, and when someone has a different opinion, it is called misinformation. It's much easier to formulate a slogan or come up with something than to worry about whether you did it right and take the time and effort to research sources and get the right information.

Because of this intersection between social media and cultural shifts, we are currently losing the battle. It threatens many foundations of public health. We need to create networks of people committed to the truth.

What advice do you have for new healthcare leadership?

Change doesn't come easily in government. If we move at least five people, it will have to be reviewed by Congress. That makes it really difficult.

If possible, use evidence to make decisions. I've heard a lot of tweets and short social media posts saying, “We're doing this, we're doing that.” Let's look at the evidence about what an effective treatment is, and then if it's good, we'll do it with her.

Those are my two most important pieces of advice.



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