SOCMA: Society of Chemical Manufacturers and Affiliates

June 28, 2012

In a major victory for the American people, President Obama is expected to sign the Food and Drug Administration's user fee bill into law after it was passed this week by the Senate in a 92-4 vote. The bill makes 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.

SOCMA affiliate the Bulk Pharmaceuticals Task Force (BPTF), which is anxiously awaiting the signing of the bill, calls it a turning point in the fight to eliminate contaminated or counterfeit drug products from consumer shelves.

The user fee bill includes authorization of the Generic Drug User Fee Act (GDUFA), legislation that would improve safety of the drug supply chain by requiring inspection of all foreign and domestic drug production facilities. BPTF has long advocated for increased resources for the FDA to conduct more inspections of foreign drug ingredient manufacturers. BPTF worked with other industry groups last year to negotiate the terms included in GDUFA.

For more on the issue, contact BPTF Executive Director John DiLoreto.