The US Food and Drug Administration (FDA) today announced a new program aimed at speeding up the approval process for generic drugs.
FDA predicts that the program, aptly called GIVE the Generic Initiative for Value and Efficiency, would give a gift to generic companies by helping the FDA approve generic drugs more quickly. FDA approved 682 generic drugs in fiscal year 2007, 30 pct more than it did the prior year, although an increasing number of generic applications are submitted each year.
Under the program, FDA will immediately review applications for generic drugs that face no blocking patents or exclusivity provisions. The FDA said this change will let these generic drugs reach consumers more quickly. In plain English, GIVE aims to increase the number and variety of generic drug products available to drive down the costs of drugs.
The program will focus staff efforts on program goals and provide background and impetus for development of additional review efficiencies. Additional changes anticipated include, but are not limited to:
- A continued focused hiring plan, using currently available resources, to address critical review staff needs.
- Using the Office of Pharmaceutical Science to augment review capability in microbiology (critical need area).
- Identification of supplements for low-risk manufacturing changes that may qualify for a less intense level of review.
- Base risk decisions on manufacturer’s product and process understanding and the robustness of their internal quality system to control their processes.
- Enhanced use of electronic programs for handling submissions and internal documents.
- Supplement reduction for low-risk products.
- Consideration of additional changes to application procedures to increase the availability of more lower-cost generic alternatives to the public.
FDA said it would increase its current review staff of 215, increase the use of electronic submissions, and use other resources from within FDA to review applications.
A generic drug is identical, or bioequivalent to, a brand name drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use. Drug companies must submit an abbreviated new drug application (ANDA) for approval to market a generic product.
The Drug Price Competition and Patent Term Restoration Act of 1984, more commonly known as the Hatch-Waxman Act, made ANDAs possible by creating a compromise wherein generic drug companies gained greater access to the market for prescription drugs, and innovator companies gained restoration of patent life of their products lost during FDA’s approval process.
