The Bulk Pharmaceuticals Task Force (BPTF), an affiliate of the Society of Chemical Manufacturers and Affiliates (SOCMA), has welcomed House Energy and Commerce Committee approval of the Food and Drug Administration Reform Act of 2012, which will ensure continuation of various FDA programs and authorize new ones, including one that will help safeguard the nation’s drug supply and result in greater scrutiny of drug manufacturing in high-risk regions of the world.
The FDA Reform Act of 2012 (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 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.
“We are pleased to see this legislation that BPTF and other industry groups worked so hard to bring about make it through the House Energy and Commerce Committee with bipartisan support,” said BPTF chair Patty Benson, quality assurance director of SAFC. “BPTF strongly supports the goals negotiated in this legislation, and we believe this will help level the playing field for domestic pharmaceutical producers by requiring that foreign producers meet the same safety standards.”
Under the terms of GDUFA, 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, which would help reduce drug shortages and bring drugs to market faster. The legislation would allow the FDA to perform inspections on a risk basis, focusing on the facilities posing the greatest risk to drug safety.
This House committee approval follows Senate Health, Education, Labor and Pensions Committee approval of similar legislation, the Food and Drug Administration Safety and Innovation Act (S. 2516), last month. BPTF looks forward to swift bipartisan approval on the House and Senate floors on both bills.
For more information, visit www.socma.com.