U.S. Legislative Response to Heparin Crisis Begins to Take Shape
This article was originally published in The Gold Sheet
The broad outlines of the timing and scope of a U.S. legislative response to the global pharmaceutical supply chain crisis are taking shape.
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COMPETES Act also includes enhanced penalties for drug makers who falsify or destroy records, power for the FDA to recall harmful drugs, funding for drug manufacturing technology and additional supply chain flexibility efforts.
The user fee legislation Congress approved June 26 makes quality risk management a GMP requirement, further pressuring pharmaceutical manufacturers to make sure they are protecting their global supply chains. The bill directs FDA to inspect based on risk rather than time or location, and to rely on trusted foreign inspectorates, while adding new user fees for generic drugs that will boost funding for further expansion of the agency’s inspectorate.
FDA is continuing to draft a regulation for strengthening supply chain controls that he had announced in June 2010, Brian Hasselbalch of the agency’s center for drugs told a Parenteral Drug Association conference last month.