More than three years have passed and the Food and Drug Administration still hasn’t restructured its staff to better monitor drug safety as recommended by experts after the Vioxx scandal. Congressional investigators say the FDA has yet to follow through on changes suggested in 2006 to help the agency detect problems with drugs taken by millions of Americans. Those recommendations came after the dangerous episode involving Vioxx. As all America now knows, the FDA approved Vioxx in 1999, only to pull it from the market in 2004 after linking it to heart attack and stroke.
Agency officials have made some changes to drug oversight, according to a Government Accountability Office report, but the FDA continues to give the bulk of its decision-making power to scientists who approve new drugs, rather than those who monitor the side effects of drugs on the market. “It is not yet clear if or when FDA’s decision-making process will be substantially improved as a result of its efforts,” said the GAO report.
Within the FDA bureaucracy, scientists tasked with reviewing new drug applications have traditionally had the most say over questions of safety, even after drugs are approved. But outside experts say leaving such key decisions to the scientists who first cleared the drugs could lead to inadequate safety actions, putting prescription drug users at risk. Dr. Diana Zuckerman of the National Research Center for Women and Families in Washington says: “There’s this desire on the part of the people who first approved the drug to say, ‘We predicted everything and it’s fine.” Dr. Zuckerman and others say such decisions should be made with equal input from the FDA’s office for monitoring reports of side effects collected from across the country.
The GAO, the Institute of Medicine and other experts have long recommended that the so-called Office of Surveillance and Epidemiology be given equal authority on drug safety with the agency’s Office of New Drugs. But GAO investigators report that FDA leaders still have not transferred key responsibilities to surveillance officials. It’s time for the FDA to establish independence for its post-market surveillance. In 2006, the GAO made some specific recommendations to the FDA.
The GAO report requires the FDA to set a timetable for transferring new responsibilities to the surveillance office. Despite a formal memo between the offices designed to put them on equal footing, the new drug office still retains nearly all the power over regulatory decisions, according to the report. In its response to the report, the FDA says major decisions about drug safety are delegated to the new drugs division because that is “where staff with the broadest expertise and experience” on product safety issues reside.
The FDA claims that it intends to give the surveillance office more responsibilities, but only after its nearly 200 employees gain the experience and resources needed to take on those tasks. The Office of New Drugs has more than 900 employees. According to the GAO, the number of surveillance staffers would have to double in coming years to accommodate the additional work being assigned to the unit.
Source: Associated Press
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