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A Matter Of Precedent: US FDA Sometimes Labors Under Weight Of Unpopular Or Unfavorable Decisions

 
• By Sue Sutter

As agency observers wonder whether and how political considerations will impact the timing of a COVID-19 vaccine approval or authorization, the Pink Sheet looks at instances through the years where agency staffers found themselves operating under precedents with which they disagreed or that didn’t work out as expected.

The convergence of the COVID-19 pandemic and the 3 November presidential elections has US Food and Drug Administration observers wondering whether the agency might approve or authorize a vaccine before Americans go to the polls, or whether HHS secretary Alex Azar would allow a vaccine to quickly reach the market over the objections of FDA leaders.

All the hand-wringing got us thinking about an instance nearly nine years ago where the HHS secretary overruled FDA scientists’ view of a drug application, an

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