Plasma Authorization Raises Fears Of Politically-Influenced COVID-19 Vaccine Decisions, Compromised FDA
Executive Summary
US FDA Commissioner Hahn’s credibility is in question following an emergency use authorization for convalescent plasma, leading some former officials to push for new agency leadership. Hahn’s actions, combined with President Trump’s attack on FDA staff as being ‘deep state’ actors, may compromise the public trust in the agency’s work during COVID-19 and beyond, former FDA officials say.
You may also be interested in...
Sliding Scale: Bar For COVID Therapeutics EUAs ‘Can Be Somewhat Variable’ – FDA’s Peter Marks
Marks appeared to use the variable EUA bar to justify what many viewed as early mistakes by FDA during COVID-19, and to emphasize the importance of physician awareness of the strength of evidence used to authorize a drug.
How Can FDA Avoid Political Interference? More Independence, Fewer Appointees, GAO Says
Former agency heads and outside experts suggest structural reforms in interviews with GAO. Report notes FDA had 10 political appointees in 2020 versus 5 in 2016 and 3 in 2022. House Select Subcommittee on the Coronavirus Crisis describes Trump Administration actions against FDA in its final report.
US FDA Commissioner Califf Takes On Misinformation, Starting With ‘Rumor Control’
Agency leader expects to spend about a year developing a strategy to combat misinformation. On 5 August, the agency unveiled what appears to be an early component of the initiative – a web page titled Rumor Control, with facts about the safety and components of COVID-19 vaccines.