GPhA Commends House Approval of Historic User Fee Proposals

Published Online: Wednesday, June 6, 2012
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Washington, D.C. (May 30, 2012) — The Generic Pharmaceutical Association (GPhA) today applauded the U.S. House of Representatives for approving the historic user fee proposals recently negotiated by industry and the Food and Drug Administration (FDA) for generic drugs and biosimilar products.

“Today’s vote moves American consumers one step closer to receiving faster access to low-cost, high-quality generic medicines,” said Ralph G. Neas, President and CEO of GPhA. “With this historic legislation now approved by both the House and the Senate, we urge Congress to quickly present President Obama with a unified measure 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 inspection parity of both foreign and domestic manufacturing sites. Most importantly, the programs will make certain that all Americans receive timely access to safe, effective and affordable generic drugs.

Specifically, 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.

As the user fee legislation moves into a conference committee, GPhA urges Congress to address additional areas that would further increase access to safe and effective generic medicines. For example, GPhA supports the Senate-passed language with respect to restricted access drugs. This language will greatly improve the safety of our nation’s drug supply and expedite consumer access to generic versions of these products. Additionally, GPhA supports the House-passed language addressing the unintended consequences of the 30-month forfeiture provision in the Medicare Modernization Act (MMA) of 2003.

Finally, GPhA supports the framework included in the Senate legislation for increasing drug supply chain security, and urges Congress to continue working to include a complete system in the final bill. The model proposed by Senator Bennet and Senator Burr is supported by the Pharmaceutical Distribution Security Alliance (PDSA) — a multi-stakeholder initiative whose membership, including GPhA, spans the U.S. pharmaceutical distribution system — and would increase patient access to safe medicines while improving the security of our country’s drug distribution system.

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.

GPhA represents the manufacturers and distributors of finished generic pharmaceuticals, manufacturers and distributors of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry. Generic pharmaceuticals fill 80 percent of the prescriptions dispensed in the U.S. but consume just 27 percent of the total drug spending. Additional information is available at

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