New FDA Regulation Will Speed Generic Drug Approvals

August 18, 2003
FDA will implement a final rule today to speed the approval of generic drugs, resulting in billions of dollars in health care savings for consumers. The rule allows only one automatic 30-month stay for each generic application.

The final rule also clarifies the types of drug patents that can be submitted for listing in the Orange Book -- FDA’s source for each drug’s applicable patents. It will prevent drug companies from submitting certain new patent claims in order to extend their marketing protection and delay the approval of a generic equivalent.

The final rule balances drugs companies' need for intellectual property protections and the desire to have equivalent generic drugs approved and marketed -- a balance intended by the 1984 Hatch-Waxman Amendments to the Federal Food, Drug and Cosmetic Act.

FDA has determined that it will only allow submission of patents that claim the:

• drug substance (active ingredient),
• the drug product (formulation and composition),
• and the method of use (injectable, tablet, etc.)

Although these changes should enable generic drugs to reach the market sooner, FDA said it will continue to make the generic drug approval process more efficient with the goal of lowering national health care costs by reducing the cost of bringing safe and effective generic drugs to market.

Legislation now pending in Congress to provide a Medicare prescription drug benefit may have an impact on the new rule. FDA said it would work with Congress to keep the implementation on track.