Three years after the Vioxx safety debacle, the FDA has yet to improve its drug safety oversight, according to Government Accountability Office findings. Vioxx was pulled from the market in 2004 after the drug was linked to an increased risk of heart attack and stroke. Two years later, the GAO, Institute of Medicine and other experts made recommendations to the FDA in order to prevent another Vioxx-like catastrophe.
Currently, the FDA's Office of New Drugs has the most influence over whether a drug gets approved. But it's impossible for those scientists to know the long-term effects of the drugs they allow to market. That's where critics want the FDA's Office of Surveillance and Epidemiology to step in. They say that office should be given equal responsibility in approving new drugs. There is a formal agreement between the two offices regarding shared responsibility for new approvals, but substantially all decisions are still made by the Office of New Drugs, as FDA leaders haven't granted certain necessary approval responsibilities to the Office of Surveillance and Epidemiology.
The FDA says it will transfer more drug approval responsibilities to the surveillance office as soon as its 200 staffers have enough experience and resources to handle the increased responsibility. It would also have to double its staff to handle the additional workload. The Office of New Drugs boasts 900 highly-experienced employees.
The GAO report wasn't all bad, however. It noted that the FDA has made some strides in its drug safety monitoring effort. Those included a better computer tracking system for drug side effect reports and a more vigilant system for gathering drug safety issues from outside the agency.
- take a look at the AP report