Improving Safety Lags at FDA



Three years after the Vioxx scandal put the FDA’s problems front and center, congressional investigators have reported the agency has done little to improve safety. Suggestions made in 2006 following the agency debacle in which an approved drug in 1999 was linked to heart attacks and strokes five years later, have made very little headway.

For example, the FDA was asked to restructure its staff to better monitor drug safety. However, this hasn’t happened. Rather than giving decision-making power to scientists who focus on and monitor the side effects of drugs on the market, the FDA’s primary decision-making is still with scientists who okay new drugs. Outside experts have stated these decisions of safety should not be left to the scientists who first approved the drugs because it could lead to safety actions that are inadequate and hurt prescription drug takers.

The Government Accountability Office, the Institute of Medicine and others have recommended for years that the Office of Surveillance and Epidemiology be given the same amount of authority when it comes to drug safety as the FDA’s Office of New Drugs. However, leaders at the agency have not transferred any power over.

Congressional investigators say the FDA has made some improvement and continues to work on the following areas:

  • Developing a system to help resolve disagreements on drug safety between staff
  • Overhaul the agency computer system that tracks and sorts reports of drug side effects
  • Gathering further reports about drug safety issues from different federal agencies and private medical systems

One thing they might consider is the surveillance office has 200 employees. The New Drug Office has 900. The GAO states the number of staffers in the surveillance office will need to double in the near future to keep up with the work the FDA says is coming its way.

If you’re an out of work drug scientist, you may want to figure out if working for the FDA’s surveillance office is something you can do.