The Generic Pharmaceutical Association (GPhA) applauded the U.S. House of Representatives for giving final approval to the historic user fee proposals recently negotiated by industry and the Food and Drug Administration (FDA) for generic drugs and biosimilar products.
“GPhA 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,” said Ralph G. Neas, President and CEO of GPhA. “The historic user fee legislation – the most important pharmaceutical legislation since the 1984 Hatch-Waxman Act – will provide FDA with additional resources and ensure all participants in the U.S. generic drug system, whether U.S.-based or foreign, comply with our country’s strict quality standards. Very importantly, the programs will make certain that all Americans receive timely access to safe, effective and affordable generic drugs. We now urge the Senate to quickly give final approval to the user fee legislation so that consumers, the FDA, and generic manufacturers can begin to see its many benefits.”
Specifically, GDUFA calls for the generic drug industry to pay $299 million annually in user fees for the next five years, beginning October 1, 2012. 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 for preventing abuse of the FDA’s citizen petition process. These actions will greatly improve the safety of drug supply and expedite consumer access generic drugs.
Though the final legislation did not address some additional areas that would further increase access to generic medicines – such as the Senate-passed language with respect to restricted access drugs and the proposed model for increasing drug supply chain security – GPhA is encouraged by the progress made on these important issues and remains committed to working with Congress to advance them in the future.
The user fee programs are part of GPhA’s multi-pronged effort to ensure patients have access to lifesaving generic medicines. In combination with the Accelerated Recovery Initiative (ARI) – the generic industry’s unprecedented multi-stakeholder initiative designed to accelerate the recovery of certain critical drugs in short supply to patients in need – the generic industry has stepped up to provide private sector leadership at its best and private-public sector partnerships that will work.
Source: GPhA press release