ARLINGTON, VA – The Society of Chemical Manufacturers and Affiliates (SOCMA) Bulk Pharmaceuticals Task Force today commends the U.S. Senate on passage of the Food and Drug Administration Reauthorization Act of 2017, which includes the Generic Drug User Fees (GDUFA) program that is designed to improve the quality and availability of drugs throughout the supply chain.
BPTF was a key stakeholder in negotiating the terms of GDUFA with the FDA.
“It was a long negotiation process, but we are pleased to see the bipartisan support in Congress in reauthorizing this important piece of legislation,” said John DiLoreto, BPTF Executive Director. “Approval of GDUFA allows the federal government to continue to work toward bringing generic drugs to consumers faster than ever, and the new fee structure will significantly reduce the costs for active pharmaceutical ingredient (API) manufacturers, which are our members.”
BPTF will continue to work closely with the FDA and other industry stakeholder groups on GDUFA implementation and looks forward to seeing the bill signed into law.
The Bulk Pharmaceuticals Task Force (BPTF), an affiliate of SOCMA, is an industry trade organization for manufacturers of active pharmaceutical ingredients (APIs), their intermediates and excipients.