Republicans Ratchet Up Attacks On US FDA’s COVID Response

Pair of letters that target research focus and therapeutic review speed is a potential preview of the kind of oversight that the agency may be subject to if the GOP retakes control of the House this fall.

United States Capitol Building at sunset - Washington, DC, USA - Image
• Source: Shutterstock

House Republicans are using the one-year anniversary of President Biden’s inauguration to launch a fresh round of attacks on the US Food and Administration, offering a preview of some of the campaign rhetoric the agency might expect to hear ahead of the midterms in November as well as a taste for the kind of oversight the agency may receive if the GOP retakes the House in the elections.

In separate letters sent on 19 January, Republicans on the Energy & Commerce and the Oversight & Reform committees asked...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from US FDA

US FDA Leadership Changes Become Reality TV

 

Suddenly the leadership changes at the US FDA’s Center for Biologics Evaluation & Research have begun to feel like a soap opera. That is not a recipe for regulatory predictability.

Last Minute Course Shifts, Focus On Unknowns: What Sponsors Should Learn From Prasad’s Interventions

 

The once and current CBER director’s justification for his COVID-19 decision stands as a warning of the uncertainty sponsors, particularly those in the vaccine space, may now face at FDA.

Precigen’s Papzimeous Approval Allows US FDA CBER Director To Emphasize Flexibility

 

Returning FDA biologics center director Vinay Prasad used the Papzimeous approval announcement to reinforce his flexibility on rare disease therapies after several complete response letters and his brief departure from the agency.

A US FDA Move to Revoke Pfizer’s Pediatric COVID-19 Vaccine EUA Could Raise Supply Questions

 

Pfizer still has not submitted a supplemental biologics license application for the youngest population even though people familiar say it has dominated that market. Moderna says it can “step up” supply.

More from Agency Leadership