Pallone pushes bill to speed approval of generic drugs

Rep. Frank J. Pallone Jr., senior Democrat on the House Energy and Commerce Health Subcommittee,visited Ohm Laboratories Inc., a wholly owned subsidiary of Ranbaxy Pharmaceuticals Inc., on Monday to highlight the Generic Drug and Biosimilar User Fee Act of 2012.The bipartisan bill introduced by Pallone would establish two programs at the Food and Drug Administration to help speed the delivery of low-cost drugs and other medicines to patients.Pallone joined New Brunswick Mayor Jim Cahill and representatives of New Jersey Citizen Action, Ranbaxy Pharmaceuticals and Horizon Blue Cross Blue Shield New Jersey to promote the bill and the benefits it would provide in both patient care and health care savings.“Generic drugs save lives at lower cost, and bringing generic and biosimilar drugs to market faster must be a priority,” Pallone said. “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.”Generic drugs, advocates say, have provided more than $824 billion in savings to the nation’s health care system in the past decade, but there is a backlog of generic drug applications at the FDA.The bill would authorize an agreement between generic drug manufacturers and the FDA that would expedite review of generic drug applications.Ranbaxy Pharmaceuticals is an international pharmaceutical company, headquartered in Princeton. With this legislation, companies such as Ranbaxy would be able to deliver more low-cost drugs to patients and create jobs in New Jersey.The bill also would authorize 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 biological process, rather than a chemical process.“This legislation would help lower health-care costs for millions of Americans and support local generic drug manufacturers,” Pallone said, “and I look forward to moving it through Congress.