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 Product and Drug Substance 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 Bulk Pharmaceuticals Task Force (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.
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 (GDUFA) 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. More importantly, BPTF serves as a watchdog, holding the FDA accountable for achievement of negotiated goals and commitments under GDUFA.