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FDA Continues To Stall New Safety Measures After Vioxx Scandal

In 2004, the US Food & Drug Administration came under fire after the prescription pain drug Vioxx was pulled from the shelves after it was linked with heart attacks and stroke despite being approved just five years before.

Today, the Government Accountability Office (GAO) has released a report that says the FDA has not done what it promised to increase prescription drug safety and to prevent the same mistakes from happening again in the future. In 2006, a number of changes were outlined in order to improve how drugs already on the market are monitored by the agency. However, three years later, not all steps have been taken to prevent another dangerous drug episode.

Currently, most of the power in the FDA belongs to the scientists who test drugs for the market – scientists who may be reluctant to recall the same drugs that they approved a few years before. The proposed changes would spread the responsibility and make certain that when deadly drug side effects are seen, action is taken quickly. Right now, the GOA says that the FDA’s post-market drug surveillance program is still lacking. It also asks that the FDA give them a formal timetable in which the recommended changes take place.

The GOA did note that some important changes have been made since the Vioxx scandal put a spotlight on the problems with the FDA’s post-market drug vigilance. Since 2006, the FDA has revamped their computer adverse effect reporting system, gathered reports from government agencies on drug safety, and developed a system to resolve internal conflicts about drug safety.

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