Congressman Frank Pallone, Jr. (D-NJ), Senior Democrat on the House Energy and Commerce Health Subcommittee Thursday joined with House Energy and Commerce leadership to introduce the "Generic Drug and Biosimilar User Fee Act of 2012." The bill establishes two critically important programs at the U.S. Food and Drug Administration (FDA) that will help speed the delivery of low-cost drugs and other medicines to patients.
Generic drugs have provided more than $824 billion in savings to the nation's health care system in the last decade, but there is still a significant backlog of generic applications at the FDA. The bill authorizes the Generic Drug User Fee Agreement which was recently reached by the FDA and generic drug manufacturers. It will expedite review of generic drug applications so these drug products can be brought to market faster and into the hands of consumers.
"Generic drugs save lives at lower cost, but unfortunately the median time for a generic drug approval has doubled to 32 months," said Pallone. "This bipartisan legislation will go a long way to giving the FDA the resources it needs to review these drug applications in a timely and effective manner."
The bill also authorizes the Biosimilars User Fee Agreement, another new FDA program that resulted from a provision in the Affordable Care Act. It will provide funding for the review and approval of new promising medicines, also known as follow-on biologics or biosimilars, to patients. Biologics are medicines made by a biologic process rather than a chemical process.
"Bringing generic and biosimiliar drugs to market faster should be a priority. I look forward to moving this bipartisan legislation through Congress so we can achieve lower health care costs."