U.S. regulators and lawmakers recently helped advance what one generic drug industry leader coined “the most important pharmaceutical legislation since the 1984 Hatch-Waxman Act”: a plan that could help employers get a better handle on rising health care costs.
The House of Representatives has approved historic user fee proposals negotiated by the pharmaceutical industry and the Food and Drug Administration for generic drugs and biosimilar products.
Ralph G. Neas, president and CEO of the Generic Pharmaceutical Association, says his organization “fully supports the Food and Drug Administration Safety and Innovation Act and applauds both the House and Senate for the remarkable effort and bipartisan cooperation they have shown throughout this process.”
Specifically, the Generic Drug User Fee Act calls for the generic drug industry to pay $299 million annually in user fees for the next five years, beginning Oct. 1. This funding is supplemental to what Congress appropriates to FDA each year and will enable the FDA’s Office of Generic Drugs to provide timely approval of generic medicines, and increase funding for generic manufacturer facility inspections, which are required before new generics can be approved.
GPhA also commends Congress for addressing in the user fee legislation the unintended consequences of the 30-month forfeiture provision in the Medicare Modernization Act (MMA) of 2003 and preventing abuse of the FDA’s citizen petition process. These actions will greatly improve the safety of our nation’s drug supply and expedite consumer access generic drugs.
The user fee programs are part of GPhA’s multi-pronged effort to ensure patients have access to generics. Currently, generics fill 80% of the prescriptions dispensed in the United States but account for just 27% of the nation’s total drug spending.
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