Report Chronicles Hahn’s Politicized Career at FDA
As the transition of power concludes in Washington, DC and CDER director Janet Woodcock assumes temporary control of FDA until a new commissioner is appointed, we are reminded just how important an independent and a free-from-political-interference agency really matters. A Vanity Fair special report examines how former FDA commissioner Stephen Hahn became the most politicized commissioner in recent history and 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.
Americans’ first look at the new commissioner 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 episode emboldened the Trump administration to use its new-found backdoor to FDA to push numerous other products the White House was being bombarded with from outside entities and allies, according to Vanity Fair. “There was President Trump’s ex-wife Marla Maples pushing an eight-minute antibody test on behalf of a North Carolina doctor,” it says. “Jill Kelley, the infamous Tampa socialite best known for a bit part in the sex scandal that felled CIA director General David Petraeus, sought to advance a Covid-19 saliva test. People identifying themselves as friends of current House Republican leader Kevin McCarthy and former Republican Speaker of the House Paul Ryan proposed pet projects. A ventilator company with ties to Ivanka Trump was ‘willing and WANTS to help produce ventilators for adults ASAP but needs FDA-expedited assistance,’ according to an email from a White House special assistant.”
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.
Vanity Fair says that interviews with various insiders and those familiar with FDA’s pandemic response revealed “an agency stumbling through the pandemic, buffeted by mercurial demands from the White House, political sabotage from its parent agency, Health and Human Services, and an inexperienced commissioner unsure of whom to trust... The result was a ‘catastrophic failure of leadership…that has manifested in unforced error after unforced error,’ an HHS official said. The FDA’s actions likely slowed industry testing, sowed public distrust, led to the seesaw approval and revocation of an ineffective remedy, and might have even delayed the approval of a vaccine, in an effort to compensate for the perception that it had been co-opted by Trump.”
Internally, Hahn was facing a backlash from career FDA officials who were concerned that if the agency’s credibility was lost because of real or perceived interference, Americans will not rely on the agency’s Covid-19 vaccine reviews and other product determinations, according to Vanity Fair. “Hahn was forced to take a side. He ultimately joined with the agency’s career officials in their call to fully vet a vaccine, regardless of the political fallout,” it says. “On September 21, the FDA sent the White House’s Office of Management and Budget new vaccine guidance, calling for drug developers to monitor patients enrolled in their clinical trials for roughly two months after their last shot. It would push any vaccine approval beyond the November election.”
HHS secretary Alex Azar now was working behind the scenes to have Hahn fired over the vaccine delay. “Hahn moved his staff out of HHS headquarters and returned to the FDA’s White Oak campus, according to the report. “‘We’re leaving HHS. They’re all evil,’ an official recounted him saying,” it said. “Though Hahn had been ‘subjugated to Trump,’ said someone in frequent contact with the commissioner, ‘he became block and tackle for this to be done right.’”
Last month, the White House staged a vaccine summit to praise the president and Hahn was invited and expected to come, according to Vanity Fair. “But he sidestepped the invitation, sending Keagan Lenihan, his chief of staff, instead,” it says. “The summit’s organizers were livid at Hahn’s absence, one HHS official said. But it appeared that the commissioner had finally learned his lesson: He could either stand next to Trump or stand with his agency.”