Bill proposes risk plan for all approvals

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Proposed drug safety legislation would require each new drug and biologic approved by the FDA to have a Risk Evaluation and Mitigation Strategy (REMS).

Senate Health, Education, Labor and Pensions Committee chairman Mike Enzi (R-WY) and ranking Democrat Edward Kennedy (MA) released details of their draft legislation: the Enhancing Drug Safety and Innovation Act of 2006.

Under the proposal, drug sponsors and the FDA would review the REMS at least annually for three years, as well as in applications for a new indication, when the sponsor suggests changes, or when the FDA requests a review. Sponsors would propose a REMS and the FDA would approve it after “structured negotiations.”

Enzi and Kennedy said the REMS is intended to be an integrated, flexible mechanism to acquire and adapt to new safety information about a drug. At a minimum, REMS would have to contain the FDA-approved professional labeling; 15-day, quarterly and annual reports of adverse events; a surveillance plan to assess known serious risks and to identify unexpected serious risks; and a timetable for periodic REMS assessment.

Increased drug user fees would be used to review REMS proposals and assessments and for FDA's general drug safety surveillance, according to the summary.

The legislation also calls for the creation of a clinical trials registry and a clinical trials results database to be maintained by the National Institutes of Health.

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