SOCMA’s Bulk Pharmaceuticals Task Force Hails Senate Passage of FDA User Fee Bill
Urges the House to Follow Suit
FOR IMMEDIATE RELEASE
May 25, 2012
Senior Manager, Public Relations & Media
Washington, DC – The Bulk Pharmaceuticals Task Force (BPTF), an affiliate of the Society of Chemical Manufacturers and Affiliates (SOCMA), today commended the Senate for approving the Food and Drug Administration Safety and Innovation Act (S. 3187), bringing the nation one step closer to a safer drug supply chain. The legislation, approved 96-1 yesterday, reauthorizes FDA user fee programs and creates a new user fee program for generic drugs.
The Generic Drug User Fee Act (GDUFA), which is included in S. 3187, levels the playing field for domestic pharmaceutical producers by requiring that all foreign and domestic drug production facilities be inspected, a key step in improving the drug supply chain.
“Our goal when we negotiated this legislation with FDA last year was to hold all players contributing to the U.S. generic drug system to the same inspection standards and enhance the agency’s ability to identify and track registration and contributors involved in each drug product sold in the U.S.,” said BPTF Chair Patty Benson, Quality Assurance Director of SAFC. “We are pleased that the Senate has recognized this need and passed this crucial piece of legislation with overwhelming bipartisan support.”
The House Energy and Commerce Committee passed similar legislation, the Food and Drug Administration Reform Act of 2012 (H.R. 5651), earlier this month.
“We urge the House to follow the Senate’s example and swiftly pass the bill with the same bipartisan support,” added Benson.
The generic drug industry will pay approximately $1.5 billion over five years in return for faster and more predictable review of generic drug applications, according to the terms of GDUFA. This will help reduce drug shortages and bring drugs to market faster. The legislation also allows the FDA to perform inspections on a risk basis, focusing on the facilities posing the greatest risk to drug safety.
BPTF is an industry trade group for manufacturers of active pharmaceutical ingredients, with the primary objective of seeking clarification of current regulatory requirements.
The Bulk Pharmaceuticals Task Force (BPTF), an affiliate organization of SOCMA, is an industry trade organization for manufacturers of active pharmaceutical ingredients (APIs), their intermediates and excipients.
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