On May 25th, the Bulk Pharmaceuticals Task Force (BPTF), an affiliate of the Society of Chemical Manufacturers and Affiliates (SOCMA), commended the Senate for approving the Food and Drug Administration Safety and Innovation Act (S. 3187) in a 96-1 vote. Closely following that announcement, on May 31st the House of Representatives followed suit by passing the Food and Drug Administration Reform Act of 2012 (H.R. 5651) in a 387-5 vote. S. 3187 was put through in an effort to bring the nation one step closer to a safer drug supply chain by reauthorizing FDA user fee programs and creating a new user fee program for generic drugs. H.R. 5651 includes authorization of the Generic Drug User Fee Act (GDUFA) to improve the drug supply chain by requiring inspection of all foreign and domestic drug production facilities.
SAFC Quality Assurance Director, Patty Benson, who is also a chairperson of the BPTF, spoke on behalf of the association when she said that, “we urge quick action by both House and Senate conferees to agree on a final bill that the president can sign as soon as possible.” If the bill is passed, the generic drug industry would 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. The idea behind the legislation is to help reduce drug shortages, bring drugs to market faster and work to eliminate sub-par drug products that pose a risk to end users.
To learn more about the Bulk Pharmaceutical Task Force, and their goals, read this Q&A with Patty Benson that was a follow up to her presentation from an API suppliers perspective at the ICH Q3D Metal Impurities Workshop. Links to the SOCMA press releases follow: