The Generic Pharmaceutical Association (GPhA) yesterday commended President Barack Obama for signing into law the historic user fee legislation recently negotiated by industry and the Food and Drug Administration (FDA) for generic drugs and biosimilar products.
“Today’s enactment of the Food and Drug Administration Safety and Innovation Act is a remarkable achievement for patients, industry and the FDA,” 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.”
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 are expected to reduce the average review time for most generic drug applications by nearly two years — from more than 30 months today to 10 months by the end of the program’s fifth year — and will provide increased funding for generic manufacturer facility inspections, which are required before new generics can be approved.
The three key aims of GDUFA are:
- Safety — Ensuring that industry participants, foreign or domestic, who participate in the U.S. generic drug system are held to the same high-quality standards and are inspected by FDA biennially, using a risk-based approach.
- Access — Expediting the availability of low-cost, high-quality generic drugs by bringing greater predictability to the review times for Abbreviated New Drug Applications (ANDAs) and by ensuring more timeliness in the drug review process.
- Transparency — Enhancing FDA’s ability to protect Americans in the complex global supply environment by requiring the identification of facilities involved in the manufacture of generic drugs and associated active pharmaceutical ingredients, and improving FDA’s communications and feedback with industry in order to expedite product access.
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