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Former FDA chief on the case for a more independent agency

Dr. Stephen Hahn speaks at a White House briefing at a lectern while flanked by two men
Dr. Stephen Hahn, then FDA commissioner, speaks at a White House briefing in August 2020 attended by then-President Trump and then-Health and Human Services Secretary Alex Azar.
(White House)

Dr. Stephen Hahn had been Food and Drug Administration commissioner for just seven weeks when the outbreak of the then-novel coronavirus was declared a public health emergency.

A political newcomer, Hahn was plunged into a period of unprecedented turmoil at the FDA, which was responsible for reviewing and authorizing tests, drugs and vaccines to fight the pandemic. His boss, then-President Trump, pressured and even threatened FDA regulators to speed up the process.

But last fall, Hahn openly defied the White House by publishing strict testing guidelines for experimental COVID-19 vaccines. Those requirements effectively closed the door on Trump’s goal of delivering a vaccine before election day.

Now an executive with biotech venture firm Flagship Pioneering, Hahn spoke about the importance of shielding the FDA from political influence. The conversation has been edited for clarity and length.

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What is the FDA commissioner’s role in managing outside pressure?

The creed by which FDA lives is “science and data.” But it’s a matter of fact that in Washington we’re in a political world. So I thought of the commissioner’s job as setting the agency’s direction and priorities and to help shape decisions around those priorities. But also to protect the agency from outside political forces.

The FDA is being urged to hasten full approval for the COVID-19 vaccines. It should let the process play out.

We’ve certainly had many of them in the last couple of years — not just in the U.S. — but across the globe. But I really did see my role as doing the absolute best I could to make sure that decisions were made independently by the scientific experts at the agency.

Now, everybody reads the papers, everybody understands the pressures of an election year. So you can’t 100% protect, but you want your folks to be able to do the job they’re there for which is to protect and promote American health based upon science and data. One thing I feel very proud about is that every decision the agency made was based upon the best data available and that the career scientists made those decisions.

What could be done to better protect the FDA?

I believe we should take a very hard look at putting in place a structure for an independent FDA.

Now, let me give one caveat: I do not believe that any federal agency is above oversight. But because the FDA has such an important role, because its decisions are life and death ones for Americans, and because it’s considered the gold standard around the world, I believe there has to be some mechanism in place for independent, scientific decision-making.

I’m sure there are different ways to do that.

How might that work?

You can imagine a situation where the agency has political appointees as its head but — like the Federal Reserve — there’s an independent board that provides oversight. So I think there are ways of doing it.

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I believe last year really taught us a lesson about the importance of scientific independence. Sometimes that’s really difficult in a fast-moving public health emergency coupled with a political environment such as it was.


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