FDA documents shed light on chaotic COVID decision-making during Trump administration

NTERNAL FDA DOCUMENTS SUGGEST THE NEED FOR CLEARER LINES OF AUTHORITY TO MANAGE EMERGENCY RESPONSE

Internal FDA and White House communications released by FDA in response to a Freedom of Information Act request provide a glimpse into the in-fighting, leaking and chaotic decision-making during some of the most fraught moments of the pandemic during the Trump administration.

The documents feature the controversies over emergency use authorizations (EUAs) for convalescent plasma and hydroxychloroquine, highlighting the role of the White House, celebrities, and disputes within the administration in making decisions that were at the heart of the U.S. response to the pandemic. 

One set of emails demonstrates that then-FDA Commissioner Stephen Hahn first misunderstood the data about the efficacy of convalescent plasma and then misled the public about his role in exaggerating the treatment’s benefits. Other emails show that television personalities promoting hydroxychloroquine had direct access to top FDA and White House officials. In addition, they point to a rift with NIH, with FDA officials believing leaks from NIH were undermining its authority. 

The document dump comes at a time when FDA has moved on from the Trump era but remains in a state of flux, lacking a Senate-confirmed Commissioner and with a number of senior positions being filled on an acting basis.

Oversight over COVID-19 countermeasures and restoring operations that were disrupted by the pandemic is FDA’s main focus. 

Acting FDA Commissioner Janet Woodcock is continuing to devote some of her time to the Biden administration’s initiative to develop COVID-19 countermeasures, she said this week in remarks to the Reagan-Udall Foundation for the FDA.

Rebuilding agency morale is one of her top priorities, Woodcock said.

FDA has drafted and soon will release a lengthy “lessons-learned” report about its COVID-19 experience, Woodcock said.

The emails and memos released this week suggest that some of the lessons should go beyond scientific and regulatory issues, and should include communications and the establishment of clear lines of authority among HHS agencies and between FDA and the White House. They also reinforce the wisdom of nominating a permanent Commissioner who has a firm understanding of medical product development, regulatory issues, as well as knowledge of the political process. An overriding lesson from the Trump administration is the importance of maintaining the agency’s independence from political influences over regulatory decisions. 

The emails reveal that FDA believed NIH had encroached on its regulatory authority, and that  the White House, NIH and HHS had leaked information to the press that interfered with FDA’s oversight of pandemic countermeasures.