Woodcock Asks Congress To Close API Supplier Registration Loopholes

During a House Energy & Commerce health subcommittee hearing on Wednesday (Oct. 30), FDA drug center director Janet Woodcock urged Congress to address loopholes in the agency’s authority that allow some active pharmaceutical ingredient suppliers and foreign finished product manufacturers to bypass facility registration and inspection requirements while still being able to ship and sell finished drug products in the United States. Woodcock raised the issue as lawmakers highlighted myriad issues with the pharmaceutical supply chain, especially drug shortages, manufacturing...