SOCMA’s BPTF Pleased with Outcome of Round Two of Generic Drug User Fee Negotiations


Jenny Gaines,
Director, Marketing and Communications
(202) 721-4123

New plan addresses fee structure, ensures greater accountability and reporting from FDA

WASHINGTON, D.C. – The Bulk Pharmaceuticals Task Force (BPTF), an affiliate of the Society of Chemical Manufacturers and Affiliates (SOCMA), today hailed the successful ending of negotiations for the reauthorization of the Food and Drug Administration’s (FDA’s) Generic Drug User Fee program (GDUFA).

BPTF is a longtime stakeholder in the Generic Drug User Fee program, which is designed to hold all foreign and domestic players contributing to the U.S. generic drug system to the same inspection standards, achieve risk-based inspection frequency parity, expedite the availability of more safe, affordable, high-quality generic drugs and enhance FDA’s ability to identify and track registration of manufacturers of each drug product sold in the U.S.

“We thank the FDA for their leadership in the negotiations, and we are pleased with the agreement we were able to reach on this important public safety issue,” said John DiLoreto, Executive Director of BPTF. “This new plan is not only good for the generic drug industry, but it will also benefit consumers by making safe drugs available faster. We are particularly pleased with the changes made in the new agreement that will benefit small businesses.”

BPTF will continue to work with the FDA and other industry stakeholders to implement the new plan, as it continues to represent the interests of our U.S. API manufacturers in the global market. 

Since 1921 SOCMA has represented a diverse membership of small, medium and large chemical companies located around the world.

About BPTF
SOCMA’s Bulk Pharmaceuticals Task Force (BPTF) is an industry trade organization for manufacturers of active pharmaceutical ingredients (APIs), their intermediates and excipients that market in the U.S.  Created in 2002 as an affiliate organization of SOCMA, its objective is to seek clarification of current regulatory requirements and to interact with governmental agencies on emerging issues that may impact SOCMA members.


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