FDA Drug Safety Monitoring No Better 3 Years Following Vioxx Recall: Report

A new report by the Government Accountability Office (GAO) indicates that the FDA has made little progress in its oversight of post-market drug safety, despite federal recommendations made in 2006. The agency’s drug safety monitoring came under closer scrutiny in the wake of the 2004 recall of the pain medication, Vioxx.

The GAO report found that the FDA has failed to implement changes to better monitor the side effects of drugs after they have been put on the market. While the agency has begun to take steps in the direction of restructuring to address some concerns, the agency has no timeframe for meeting objectives. The GAO report also suggests there may be too much influence being given to scientists who approve new drugs for the market.

According to the GAO, the FDA needs to develop a plan for transferring some regulatory authority from the Office of New Drugs (OND) to the Office of Surveillance and Epidemiology (OSE), which monitors drugs already on the market. The report indicates that even though the OSE’s role has increased since the GAO’s 2006 recommendations, the office still carries significantly less weight than OND in the FDA’s decision-making process.

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Concerns over FDA’s postmarketing surveillance arose after a Vioxx recall was issued for the popular pain medication due to an increased risk of heart attacks and strokes. Following the recall, the GAO and the Institute of Medicine recommended that FDA split authority over determining drug safety equally between the OND and the OSE. The new GAO report says that this has not yet happened.

The FDA says that currently the OND has the more experienced staff, lending it to be the go-to office for drug safety decisions. The FDA has said that it intends to give more power to the OSE once its staff has equivalent experience as those in OND. However, the GAO report says there is no indication of when that would actually happen or how. Currently, the new drugs office has 900 employees, compared to only 200 allocated to OSE.

Senator Charles Grassley, R-Iowa, a frequent critic of the FDA, called for the GAO report. Grassley has said that the agency has had the time it needs and should immediately implement the GAO’s 2006 recommendations.


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