Salinas, CA Researchers Question FDA Expedited Approval Of Some Drugsby Richard Kuehn on 09/05/12
I've written before on my blog about the Food & Drug Administration's (FDA) new focus on getting promising drugs to market more quickly, which is considered by many to be great news. Now, two drug safety experts, however, are questioning the policy. In an article published today in the Journal of the American Medical Association, Thomas J. Moore and Curt D. Furberg write that the FDA may be compromising prescription drug safety. They state, for instance, that a drug used for Multiple Sclerosis was brought to market but has adverse effects on the heart as well as other bad side effects. Moore has written two books on drug safety and is the director of QuarterWatch, an independent drug-safety publication that evaluates side-effect data which is reported to the FDA. Dr. Furberg is emeritus professor of medicine at Wake Forest University and is also a researcher on clinical studies. Therefore, the paper may carry some weight in the research community. According to the FDA, 35 innovative medicines were approved in fiscal 2011, with 16 receiving shortened review or another form of expedited approval. That's a number that's been exceeded only once in the past decade. There are arguments on both sides of this issue. Some patients, particularly those with terminal diseases, will try any new drug to try and stave off an early departure from the planet, regardless of the side effects. But those who have other options should discuss in depth the pros and cons of taking a drug which has been expedited through the FDA approval process, because this does increase the risk that unknown side effects will be found later.