Just days after the Senate overwhelming approved legislation to better protect the nation’s drug supply, the House of Representatives followed suit, passing the Food and Drug Administration Reform Act of 2012 (H.R. 5651) in a 387-5 vote. The Bulk Pharmaceuticals Task Force (BPTF), an affiliate of the Society of Chemical Manufacturers and Affiliates (SOCMA), welcomed the vote and urged House and Senate conferees to quickly agree on a final bill for the president’s signature.
H.R. 5651 includes authorization of the Generic Drug User Fee Act (GDUFA), legislation that would improve the drug supply chain by requiring inspection of all foreign and domestic drug production facilities. BPTF, a key industry stakeholder, has advocated since 2006 for increased resources for the FDA to conduct more inspections of foreign drug ingredient manufacturers, and they worked with other industry groups last year to negotiate the terms included in GDUFA.
“With today’s vote, the U.S. will make significant strides in ensuring that our drug supply is less susceptible to sub-par drugs from facilities with lax quality compliance standards,” said BPTF chair Patty Benson, quality assurance director of SAFC. “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.”
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.