A Matter Of Precedent: US FDA Sometimes Labors Under Weight Of Unpopular Or Unfavorable Decisions
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Plasma Authorization Raises Fears Of Politically-Influenced COVID-19 Vaccine Decisions, Compromised FDA
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.
The US FDA complete response letter for Intercept’s obeticholic acid raised speculation that the agency might be rethinking approvable endpoints for NASH. But analysts generally think OCA’s unspectacular efficacy data is behind the decision.
US FDA's decision to revoke the COVID-19 emergency use authorization for two anti-malarial drugs keeps with commissioner Hahn's stated goal of moving fast to tackle the pandemic, but shifting course as new data comes available. FDA cited new evidence as well as a reanalysis of the data it initially based the EUA on as reasons for pulling the authorization. Meanwhile, HHS Secretary Alex Azar appeared to equate the EUA revocation as opening the doors for broader use of the medicine, potentially undermining FDA's own communication on the drug, in yet another example of political leaders complicating the science and public health response to COVID-19.