US FDA And Congress: Criticism Of Leadership Ramping Up, But Bipartisan Truce Holds For Now
Senate Finance Committee’s hearing on FDA’s overseas inspection program suggests that agency’s status as a rare focus for bipartisan support amid the Trump Presidency is getting more tenuous – but still holding for the time being.
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FDA should have all coronavirus vaccines evaluated by Vaccines and Related Biological Products Advisory Committee before approval, Democratic senators and representatives say; House subcommittee also wants FDA to require 30,000 participants in Phase III trials.
Commissioner Stephen Hahn was largely spared any direct criticism during a very long House hearing on COVID-19 response activities. That is a promising sign for the agency.
Headlines about potential carcinogens in the drug supply have been a chronic, low-level challenge for the US FDA’s reputation in recent years. A recent Congressional hearing shows how much tinder is now laid for a potential flare up into a full-on crisis in confidence in the agency.