The former head of the Food and Drug Administration says there is a strong case for restructuring the agency to shield it from outside pressure.
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.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.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.
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.
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.
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