Drug makers claim FDA approval process takes too long

Posted Jun 30th 2008 5:35PM by Douglas McIntyre
Filed under: Products and Services, Industry, Consumer Experience

Drug companies have never liked the FDA. Why should a government agency tell them whether their drugs are safe or effective? The FDA approval process can be a long one, and often new treatments are turned down.

According to The Wall Street Journal, the head of Schering-Plough (NYSE:SGP) believes that an "intensifying focus on safety and a diminished tolerance for side effects at the Food and Drug Administration have dramatically lowered the odds that the drugs would make it to market -- at least not without a lot of extra time and money."

Perhaps if pharmaceutical companies had a better track record for safety, the process would not to be so long. It is not that long ago that the FDA discovered that anti-depressants could lead to suicidal thoughts. More recently the agency warned that anemia treatments including Aranesp, Epogen and Procrit increased the risk of strokes and heart attacks.

Drug company earnings may be hurt by a long FDA approval process, but, without the current system there would likely be an increase in deceased patients.

Douglas A. McIntyre is an editor at 247wallst.com.

Tags: Aranesp, Epogen, FDA, inthenews, Procrit, SGP