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10 May 2007

FDA to be overhauled

The US Senate voted overwhelmingly Wednesday to give the US Food and Drug Administration sweeping new powers to protect consumers from dangerous medicines.

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In what's being described as the "most comprehensive drug safety overhaul in more than a decade," the US Senate voted overwhelmingly Wednesday to give the US Food and Drug Administration sweeping new powers to protect consumers from dangerous medicines.

The vote, 93 to 1, would give the FDA broad authority to oversee drug safety, order changes in drug labels, and limit the use and distribution of medicines found to pose serious health risks to consumers, The New York Times reported.

The FDA's traditional role has been to ensure the safety of drugs and medical devices prior to authorising their use. The new bill, which is likely to be approved by the House of Representatives and signed by President Bush, calls for a fundamental change in the philosophy and operations of the agency, the Times said. The FDA would now be charged with monitoring and overseeing the entire life cycle of a drug - from the pre-approval review through to patients' experiences with a medicine, the newspaper said.

Taken a beating
The FDA's image has taken a beating in recent 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 from the National Academy of Sciences, the newspaper said.

"This legislation will make a major difference for families in America, ensuring the safety of our prescription drug system," said Sen. Edward M. Kennedy, (D-Mass.), the chief sponsor of the bill. "We will also have safer food for families and for pets," Kennedy added, referring to the series of high-profile food contamination problems that first surfaced last fall.

Sen. Michael B. Enzi, (R-Wyoming), said the bill was the "most comprehensive drug safety overhaul in more than a decade." – (HealthDayNews)

Read more:
Research Centre
FDA regaining independence?

May 2007

 
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