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Issues
BPTF establishes sound working relationships with regulators, allied industries and the public and serves as a reliable source for the development and implementation of balanced regulations and industry guidance resources. BPTF undertakes this advocacy on behalf of its member companies to achieve a safe, high quality drug supply chain for consumers.
The Challenge of Drug Safety
About 80 percent of active pharmaceutical ingredients are imported into the U.S. There have been several instances of human deaths and illnesses associated with imported contaminated or counterfeit drug ingredients. Lack of Food and Drug Administration (FDA) oversight, authorization, resources and management has led to significant risks to our nation’s drug supply.
Drug Supply Chain Safety
In recent years there has been much concern over consumer food and drug safety, especially for products entering the U.S. market from foreign producers. The BPTF consistently advocates for an appropriate level of resources for the FDA in order to conduct more good manufacturing practices inspections of foreign and domestic drug ingredient manufacturers.
Generic Drug User Fee Amendments (GDUFA)
In order to improve the safety of drugs entering the U.S., the BPTF is a key stakeholder in negotiations with FDA to create and implement the Generic Drug User Fee program, designed to provide sufficient resources to improve drug safety and level the playing field between foreign and domestic manufacturing facilities inspected by the agency.
BPTF’s primary goal in negotiations with FDA is to establish reasonable fees based on resources required by the agency to complete specific functions, such as application reviews and facility inspections. In addition, BPTF serves as a watchdog, holding the FDA accountable for achievement of negotiated goals and commitments under GDUFA.
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