GPhA requests prompt action on user fee proposals

April 6, 2012 6:25 AM

The Generic Pharmaceutical Association (GPhA) last week, reiterated its call for Congress to act without delay on the historic user fee proposals recently negotiated by industry and the Food and Drug Administration (FDA) for both generic drugs and biosimilar products.

“The generic industry has stepped up to do our part to help ensure U.S. drug safety, establish a more level playing field among all participants in the U.S. pharmaceutical supply chain and significantly reduce the time needed to commercialize a generic drug,” said David Gaugh, GPhA Vice President for Regulatory Sciences in testimony before the Senate Committee on Health, Education, Labor and Pensions. “The [user fee] programs will help assure 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.”

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.

The Generic Drug User Fee Act (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.

“It is vital that the agreements be approved in a timely manner so that patients, the FDA, and generic manufacturers can begin to see their many benefits,” Gaugh said. “Nothing is more important to our industry than ensuring patients have access to the lifesaving generic medications they require, and these historic agreements provide a critical step toward accomplishing this goal.”


Source:  GPhA press release

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