Transparency Looms Large In US FDA’s Next-Pandemic Legislative Agenda
Agency’s proposals for pandemic preparedness reauthorization would build on CARES Act provisions to gain greater visibility into global pharmaceutical supply chains, while also seeking deeper understanding of manufacturing quality management activities. Also included in FY 2024 budget request: long-sought drug destruction and drug recall authorities.
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US FDA Gets Wanted Pathogen Program, Manufacturers Get Longer BARDA Contracts In Competing Pandemic Prep Bills
Key House and Senate committees advanced reauthorizations of the Pandemic All-Hazards Preparedness Act. It is unclear whether new perks for the FDA and drug makers will survive as the two chambers reconcile a myriad of differences between their plans.
Energy and Commerce Republicans held off Democrats’ efforts to add drug shortage legislation back into the subcommittee-cleared pandemic preparedness bill 13 July. FDA-focused solutions have failed, GOP members said.
Commissioner also talks drug shortages, difficulty getting key agency and industry priorities done in new pandemic legislation, and how legal challenges to FDA authority could impact pharma companies desire to develop new medicines.