Time For Independent US FDA? COVID Political Pressure Reignites Debate
The political spotlight on the FDA during the coronavirus pandemic has renewed a long-standing debate as to whether it should be made an independent, Cabinet-level federal agency and freed from direct HHS oversight.
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In an interview with the Pink Sheet, Scott Gottlieb agrees with other ex-commissioners that there are benefits to an independent agency, but he thinks political forces would prevent it from ever happening.
Despite strong support from six former agency commissioners, the notion of an FDA that is independent from HHS is likely to remain theoretical, at least for the near term.
Transparency On COVID Vaccine Clinical Holds Needed, Sharfstein Says; US FDA Advisory Cmtes Offer Venue
Former acting Commissioner Josh Sharfstein argues that while agency officials have done a commendable job in overall communication on COVID vaccine development, more information is needed on the clinical holds.