GPhA hails Senate passage of historic user fee proposals

May 29, 2012 8:27 AM

Generic Pharmaceutical Association last week commended the U.S. Senate for its passage of the historic user fee proposals recently negotiated by industry and the FDA for both generic drugs and biosimilar products.

“The Senate’s vote is another critical step in ensuring patients will have access to the lifesaving generic medications they require for years to come,” said Ralph G. Neas, President and CEO of GPhA. “The Generic Drug User Fee Act will expedite the availability of low-cost, high-quality generic drugs to Americans and further safeguard the quality and accessibility of our nation’s drug supply. We urge the House to continue the remarkable bipartisan cooperation shown throughout this process and approve the legislation in a timely manner so that patients, the FDA, and generic manufacturers can begin to see its many benefits.”

The proposed user fee programs were developed last year through collaboration among GPhA, the FDA and other stakeholders. The programs are designed to 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. Most importantly, the programs will make certain that all Americans receive timely access to safe, effective and affordable generic drugs.

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 hire the scientific resources needed to provide timely approval of generic medicines. The new fees also will provide increased funding for generic manufacturer facility inspections, which are required before new generics can be approved.

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

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