BPTF Advocacy

Bulk Pharmaceuticals Task Force (BPTF) advocacy maintains an active role in a continuing dialogue with the Food and Drug Administration (FDA) and other regulatory authorities on issues related to drug safety and quality.

BPTF focuses on key areas of:

The Challenge of Drug Safety

There continues to be much concern over consumer drug safety, especially for products entering the U.S. market from foreign producers. BPTF actively advocates for increased resources for the Food and Drug Administration (FDA) in order to conduct more Good Manufacturing Practices (cGMP) inspections of foreign drug ingredient manufacturers.

To promote drug safety, BPTF reviews FDA policies and comments on drug safety. As a result of this diligence, the organization has improved the alignment between key industry stakeholders and the FDA.

Drug Product and Drug Substance Supply Chain Safety

BPTF continues to work with industry and FDA stakeholders to improve and maintain the safety of supply chains. This will better ensure an API supplier’s manufacturing and lab operations remain reliable, and that they are overseen by a suitable QMS to ensure sustainable quality and safety.

While all manufacturers should be able to maintain these systems on their own, there is no substitute for periodic and random inspections from the agency. Regardless of the location of the producer (foreign or domestic), inspections should be unannounced. In this way, the producers understand that in order to be found acceptable, their QMS must be robust and in continuous operation. This will consequently prevent an API supplier performing short-term fixes in anticipation of an announced inspection that might be three months away.

FDA should remain diligent in its oversight of the industry and upkeep its standards for foreign facility inspections to maintain a level playing field with domestic facilities.

Drug Master File (DMF)

Drug Master Files (DMFs) provide valuable information related to the production of human drugs. Manufacturing processes and facilities must meet current Good Manufacturing Practices (cGMP) and FDA’s review and approval of this information plays a vital role in the approval of new drugs. BPTF members have developed expertise in understanding and submitting DMFs by engaging with FDA on the nuances and critical elements of this information.

Generic Drug User Fee (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 Act (GDUFA). The program is 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 the 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.