Former FDA Head Hahn Urges FDA Independence
Former Trump administration FDA commissioner Stephen Hahn is urging more independence for the agency to prevent political interference. Hahn will likely be remembered as the most politicized commissioner in recent history and for how he sought to preserve the agency’s science-based gold standard by dismissing further White House meddling as the Covid-19 vaccines were being shepherded toward approval late last year (see earlier story).
Hahn was put in office just weeks before the pandemic raced across the country. Americans’ first look at the new commissioner was when he shared the podium with President Trump 3/19/2020 to discuss an emergency use authorization (EUA) for hydroxychloroquine, touted by Trump as a miracle drug for treating Covid-19. In less than three months, however, FDA revoked the EUA based on “emerging scientific data” that questioned the drug’s effectiveness and safety for Covid patients (see earlier story). The hydroxychloroquine debacle was followed by an EUA for Covid-19 convalescent plasma that Hahn assisted Trump in promoting as another miracle therapy. Hahn had to immediately walk back his interpretation of data that supported the plasma EUA (see earlier story). He was also criticized on the timing of the EUA announcement — on the eve of the Republican National Convention.
Speaking to Associated Press reporter Matthew Perrone, Hahn, now an executive with biotech venture firm Flagship Pioneering, spoke about the importance of shielding FDA from political influence. He said that one of the most important roles for the FDA commissioner is to protect the agency from outside political forces. “I believe we should take a very hard look at putting in place a structure for an independent FDA,” he said. “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.”
Hahn offered the Federal Reserve structure as an example to ensure independence at FDA. In that scenario, the agency still has a political appointee as its head “but like the Federal Reserve there’s an independent board that provides oversight,” he said. “So I think there are ways of doing it. 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.”