Source:
New York TimesSenate Approves Tighter Policing of Drug Makers By ROBERT PEAR
Published: May 10, 2007
WASHINGTON, May 9 — By a vote of 93 to 1, the Senate passed a bill on Wednesday that would give the Food and Drug Administration new power to police drug safety, order changes in drug labels, regulate advertising and restrict the use and distribution of medicines found to pose serious risks to consumers.
The bill calls for a fundamental change in the philosophy and operations of the drug agency, requiring it to focus on the entire life cycle of a drug — not just the years before its approval — as well as the experience of patients who later take it.
Under the bill, the government would establish a surveillance system to track the adverse effects of prescription drugs. Scientists would analyze data on tens of millions of patients, looking for signals that particular drugs pose serious risks.
In passing the measure, the Senate sent a clear signal that it wanted stronger action by the agency to protect public health. Senators said the bill responded to a widespread loss of confidence in the ability of the agency to protect consumers against the dangers of drugs like Vioxx, a popular painkiller withdrawn from the market in 2004.
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