FOR IMMEDIATE RELEASE
PR & Communications Department
Washington, DC – In a major victory for the American people, President Obama today signed the Food and Drug Administration's user fee bill into law, making it possible for the federal government to speed approval of lifesaving medicines, reduce drug shortages and improve the quality and availability of drugs in the U.S.
The Bulk Pharmaceuticals Task Force (BPTF), an affiliate of the Society of Chemical Manufacturers and Affiliates (SOCMA), hailed the signing of the bill, calling it a turning point in the fight to eliminate contaminated or counterfeit drug products from consumer shelves.
“For too long, the U.S. drug supply has been susceptible to sub-par quality drugs due to the lack of FDA enforcement of basic drug quality inspections of foreign facilities,” said BPTF Chair Patty Benson, Quality Assurance Director of SAFC. “By signing this bipartisan, bicameral bill into law, the president has demonstrated his commitment to improving the quality of drugs entering the U.S. and encouraging domestic job production by eliminating the economic advantage of foreign manufacturing facilities.”
The legislation includes authorization of the Generic Drug User Fee Act (GDUFA), which would improve the drug supply chain by requiring inspection of all foreign and domestic drug production facilities. BPTF, an industry trade group for manufacturers of active pharmaceutical ingredients, has long advocated for increased resources for the FDA to conduct more inspections of foreign drug ingredient manufacturers. As the leading chemical industry organization advancing drug safety, BPTF is a key industry stakeholder that worked with other industry groups last year to negotiate the terms included in GDUFA.
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.
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.