GPhA: Congress Should Move Ahead on User Fees
The Generic Pharmaceutical Association (GPhA) is urging Congress to move forward to proposal for generic drugs and biosimilar products, according to a PharmTech report.
Under the Generic Drug User Fee Act (GDUFA), the industry will pay $299 million per year in user fees for the next five years beginning 1 October 2012. The money will supplement what Congress appropriates to the US Food and Drug Administration (FDA) and allow for more scientific resources needed to provide timely generic drug approval.
In a statement, GPhA said the new fees will provide increased funding for generic-drug manufacturer facility inspections.
"The [user-fee] programs will help assure that American consumers continue to receive the significant cost savings from generics that, over the past dozen years, have provided more than $1 trillion in savings to the nation's healthcare system," David Gaugh, GPhA vice president for regulatory sciences, said in the report.
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PharmTech - GPhA Urges Congress to Move Ahead on Generic-Drug and Biosimilar User Fees