Supply Chain Confidentiality Doesn’t Stand “Sunshine Test,” Califf Says In Comments On Drug Shortages
US FDA commissioner takes aim at supplier confidentiality in remarks at ISPE annual meeting. But while greater transparency would help avert individual shortages, better economics for generic drugs are needed to solve the problem, he said.
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The stakes on Capitol Hill rose another notch as tornado hit supplies of sterile injectable drugs at North Carolina plant. Workers escaped serious injury by gathering in designated shelters; patients may need effective legislation to escape serious injury from drug shortages.
US FDA’s attempt to address drug shortage and supply chain weaknesses in the upcoming reauthorization of pandemic preparedness legislation looks unlikely as both chambers of Congress have now thrown wrenches in the plan.
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.