Helix Exams

Date Submitted: 12/12/07
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Proposal to Give FDA More Muscle Gets Mixed Reviews



Added by Bryan

Description: A U.S. Senate bill that offers up the prospect of enhanced powers for the U.S. Food and Drug Administration in its dealings with the pharmaceutical industry is drawing both praise and criticism from health experts.

Some believe the bill, approved overwhelmingly in a 93-1 vote Wednesday, would help restore consumer confidence to a regulatory system that has been shaken in recent years by drug recalls and reports of serious health risks to consumers. But others say the proposed changes don't go far enough.

Under terms of the Senate bill, the FDA would be able to mandate changes in drug labels, remove from the market drugs considered dangerous to consumer health, and order more studies of drugs already on the market. The agency would also be required to establish a database of all clinical trials of drugs to make safety issues more transparent.

The Senate bill would also enable the FDA to fine companies up to $2 million if they do not comply w

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