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GAO Reports FDA Has More Work to Do On Drug Safety

By Admin on December 22, 2009 | Last updated on March 21, 2019

Three years ago, the Government Accountability Office asked the FDA to make substantial changes in the way it oversees drugs that have already been approved and are available for use by patients. In the wake of the troubles with the FDA approved drug Vioxx and its link to heart attacks and strokes, the FDA had been charged with setting up a new office and system to track drugs currently on the market. As of the GAO's report in November, they are still working on it.

According to the GAO report, the three main areas the FDA had been asked to address were: enhance the process for decisions about the safety of drugs on the market; improve access to data about the safety of those drugs and build its capacity to handle the postmarket drug safety workload. At this point, the GAO continues, "It is not yet clear if or when FDA's decision-making process will be substantially improved as a result of its efforts."

What, if anything, has changed at the FDA? Some changes have been made to the post approval drug oversight, but according to critics, not enough. Most of the oversight power remains with those scientists who approved the drugs in the first place, the New Drug Office. This can lead to inadequate action. "There's this desire on the part of the people who first approved the drug to say, 'We predicted everything and it's fine,'" said Dr. Diana Zuckerman of the National Research Center for Women and Families in Washington.

More say over the safety concerns of these drugs was supposed to have been transferred from the New Drug office staffers to a new office charged with surveillance of drug safety: the Office of Surveillance and Epidemiology. The FDA has responded by saying that the New Drugs division maintains power over the postmarket releases because that is "where staff with the broadest expertise and experience" on product safety issues reside. The Department says it will transfer more responsibility to the surveillance office when its nearly 200 employees gain the experience and resources needed to take on those tasks. The GAO report has requested a timetable from the FDA for the transfer of responsibility to the new office.

Despite the overall lack of progress, some changes have been made. Congressional investigators did note that the FDA has made progress on some of the other issues it was asked to address including: revamping the computer system used to track and sort reports of drug side effects, gathering more reports about possible drug safety issues from federal agencies and private medical systems, and developing a system to resolve drug safety disagreements between staffers.

FDA officials declined to comment beyond the agency's response included in the report.

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