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FOR IMMEDIATE RELEASE |
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On August 18, 2003, FDA will implement a final rule that will help speed the approval of generic drugs and should result in billions of dollars in health care savings for consumers. The final rule, published in June, will limit the number of automatic 30-month stays that may delay generic drug availability. A maximum of one 30-month-stay will be permitted 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. The Final Rule will prevent innovator drug companies from submitting certain new patent claims that are unlikely to represent substantial new innovation in order to extend their marketing protection, thus delaying the approval of a generic equivalent.
The final rule balances innovator 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:
Although these changes should enable generic drugs to reach the market sooner, FDA 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.
FDA is pleased that the generic legislation passed by both the House and the Senate, and included in the Medicare legislation, S.1 and H.R.1, complements our Final Rule. FDA will continue to work with Congress on these generic approval issues during the process of completing discussions on these two bills, with the goal of enacting this important legislation as soon as possible.
Enactment of this legislation may affect the implementation of some provisions included in the Final Rule relating to the operation of the thirty-month stay.. FDA will work closely with Congress to minimize changes may result from implementing the final rule and final generics legislation, so that, when Congress does act, product developers are not subject to multiple “regimes” of regulation of generic drug competition.
FDA shares with Congress the goal of providing safe, effective and affordable medications for the American consumer. While Congress continues to work, implementing FDA’s final rule is an important and timely step toward that goal.
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