Proposal to Give FDA More Muscle Gets Mixed Reviews

Senate bill seeks to improve agency's ability to protect public from dangerous drugs

By Amanda Gardner
HealthDay Reporter

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THURSDAY, May 10 (HealthDay News) -- 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.

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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 with the new system.

One of the biggest changes outlined in the bill would give the FDA the authority to monitor drugs after they have reached the market. In the past, the agency had to negotiate with pharmaceutical companies before labeling changes could be made. It also could only request that a company remove a dangerous drug from the market and generally only had such authority before a drug was approved for use by consumers.

The FDA's image has taken a beating the last few years, starting with the 2004 removal from the market of the arthritis drug Vioxx, which was eventually found to increase the likelihood of heart attack and stroke. Senators said the new bill was an effort to restore Americans' confidence in the FDA's ability to protect consumers. The bill would also meet many recommendations made by the National Academy of Sciences.

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