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FDA Generic Drugs Final Rule and Initiative

On June 12, 2003, the Food and Drug Administration (FDA) announced new regulations and review procedures to streamline the process for making safe, effective generic drugs available to consumers. The new rule will limit a drug company to only one 30-month "stay" of a generic drug's entry into the market for resolution of a patent challenge. The FDA is also implementing changes in its review procedures intended to help improve the speed and reduce the cost of determining that a new generic drug is safe and effective, and therefore can be made available to patients.

The changes in the regulations alone will save consumers an estimated $35 billion over 10 years by making generic alternatives to certain more costly brand-name drugs available more quickly, by avoiding time-consuming legal delays. The improvements in the efficiency of review procedures, which will require changes by both FDA and generic manufacturers to improve the review process, are expected to save consumers billions more by generally reducing the time for approving new generic drugs.

For additional information see:

HHS Press Release

Fact Sheet on Final Rule

Questions and Answers about FDA's Generic Drugs Final Rule

Fact Sheet on FDA's Generic Drugs Initiative

White Paper on FDA's Generic Drugs Initiative

Final Rule

Generic Drugs Radio Spot (WMA 560 KB)

Transcript of Generic Drugs Radio Spot

Transcript of Generic Drugs Stakeholder Call (PDF 32.4 KB)

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FDA's Current Generic Drugs Activities

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