FDA becomes more cautious to avoid defective drugs

With the still very relevant recalls of FDA approved drugs, such as Vioxx, it seems that the administration will be employing a more rigorous approval plan for new medications. While an FDA spokesperson says there has been no systematic change in the process, there has been a noticeable decline in the approval rate of medications. The administration has approved only 61 percent of applications through mid-August, down from a pace of 73 percent at the same time last year.

Chris Milne, associate director of the Tufts Center for the Study of Drug Development, says that while it is still unclear whether the more cautious scrutiny will effect approvals in the long run, it is clear that the FDA is requiring new medications to safer and more effective that their predecessors.

Of particular concern is what is referred to as off-label use of currently approved drugs. This tends to increase the likelihood of side effects as more individuals are taking the drug and many doing so for ailments that the medication was not originally approved for. The FDA is very intersted in conducting more research on drugs whith high levels of off-label perscription. Analyst Steve Brozak says that he sees the FDA adopting a policy to avoid criticism in all circumstances, forcing drug manufacturers to meet an extremely high standard for approval in an effort to curtail recent spells with defective drugs.

A report has been recently published citing that the administration is at its lowest rate in over a decade in the approval of “new molecular entities,” drugs made from new chemical combinations rather than variations of existing compounds. The FDA has only approved seven thus far this year, when averaging 12 over the first seven months of past years. The cost of shepherding a drug is estimated to be just under a billion dollars and takes almost 15 years and that will probably continue to increase as it has in the past. However, the FDA has realized that the cost here is one that could have grave repercussions, as we have seen in recent years, if the means of approval are not held to the highest standards.