After months of thoughtful deliberation, the Bulk Pharmaceutical Task Force (BPTF) of the Society of Chemical Manufacturers and Affiliates (SOCMA) announced it has concluded its work with the Food and Drug Administration (FDA) and agreed to a proposal for a “generic drug user fee program” (GDUFA) designed to level the playing field between foreign and domestic manufacturing facilities inspected by the agency. The Generic Pharmaceutical Association (GPhA) and the European Fine Chemicals Group (EFCG) also participated in the talks, and BPTF worked with the latter to present a common voice for Active Pharmaceutical Ingredient (API) manufacturers.

BPTF, an industry trade group for manufacturers of APIs, has been in talks with the FDA since February, working to hammer out a nearly $300 million deal that would result in greater scrutiny of drug manufacturing in high-risk regions of the globe. Together with the GPhA and the EFCG, BPTF has ratified the FDA proposal, which includes a long-standing goal of conducting risk-based inspections of all foreign and domestic generic drug manufacturers and obtaining timely approvals for generic drugs.

“We welcome the ratification of this much-anticipated agreement and thank the FDA for their leadership on this important public safety issue,” said BPTF chair Patty Benson, quality assurance director at SAFC. “U.S. manufacturers are in an unfair situation seeing strong FDA oversight and enforcement, where some foreign sites have little or no oversight. This agreement will lead to parity and will go a long way in preventing deaths and illness associated with contaminated or counterfeit drugs.”

BPTF continues to support the concept of using a “risk-based approach” applied equally to foreign and domestic firms when considering how best to prioritize the needs and allocate resources, such as determining inspection frequency. Domestic manufacturing facilities are currently inspected every two years as mandated by Congress, but many foreign drug manufacturing facilities have never been inspected.

The ratified agreement, along with proposed legislative language, is currently pending within the Department of Health and Human Services, and will be provided to the Office of Management and Budget for review thereafter. FDA anticipates providing a generic drug user fee package to Congress in January, which could lead to legislative changes (including fees) to better protect public safety and health.

The lack of parity, potential funding/resource issues for the FDA and globalization of APIs continue to pose significant risks to U.S. consumers. BPTF believes this could be a significant step toward a safer drug supply.

For information on BPTF, or topics relating to current good manufacturing practices of APIs, visit www.socma.com/bptf.