FDA Hasn’t Learned Its Lesson From Vioxx Fiasco

Three years since major changes were recommended for how the Food and Drug Administration monitors drug safety after the Vioxx painkiller scandal, the federal agency has yet to implement most of the suggested improvements, according to Congressional investigators.

Vioxx, the blockbuster pain drug that was FDA approved in 1999, was later pulled from the market in 2004 after it was associated with increased risks of heart attack and stroke. The Vioxx situation raised a red flag at the FDA, which was criticized by many for allowing a dangerous drug to remain on the market and injure or kill thousands of patients.

Officials from the Government Accountability Office say while the FDA has made some changes to its drug-monitoring duties since Vioxx, the agency still depends largely on scientists who approve new drugs and not enough on researchers who monitor drugs for potentially dangerous side effects once a new drug hits 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,” according to the GAO report obtained by The Associated Press.

The fact that the FDA has not learned its lesson from the Vioxx mess means millions more drug users may still be at risk of death or devastating injuries from dangerous drugs that are FDA approved and allowed to remain on the market for years.

Changes in FDA Supervision Not Yet Implemented

The GAO, the Institute of Medicine and other experts have for years said the FDA’s Office of Surveillance and Epidemiology should be given the same authority on drug safety as the agency’s Office of New Drugs. However, years after Vioxx and the recommendations issued in 2006, government investigators say FDA leaders still have not transferred key responsibilities to surveillance officials, according to the AP report.

The GAO’s report calls on 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 GAO report to be released Wednesday.

The FDA said 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, the AP reports.

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