GPhA applauds Senate HELP Committee for favorably reporting user fee proposals

April 27, 2012 2:58 PM

Generic Pharmaceutical Association (GPhA) commended the Senate Committee on Health, Education, Labor and Pensions for favorably reporting the historic user fee proposals recently negotiated by industry and the Food and Drug Administration (FDA) for both generic drugs and biosimilar products.

“The Committee’s vote marks a vital step in enacting these historic agreements into law and ensuring that American consumers continue to receive the significant cost savings from generics that, over the past dozen years, have provided more than $1 trillion in savings to the nation’s health care system,” said Ralph G. Neas, President and CEO of GPhA. “We commend Chairman Harkin and Ranking Member Enzi for their tireless work on behalf of this critical legislation. The Generic Drug User Fee Act will expedite access to low-cost, high-quality generic drugs for Americans and further safeguard the quality and accessibility of our nation’s drug supply.”

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 USA’s 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.

“We urge the Senate to approve the full Food and Drug Administration Safety and Innovation Act in a timely manner so that patients, the FDA, and generic manufacturers can begin to see its many benefits,” Neas said. “Nothing is more important to our industry than ensuring patients have access to the lifesaving generic medications they require, and this historic legislation provides a critical step toward accomplishing this goal.”


Source: GPhA press release

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