The U.S. Food and Drug Administration continues to sweat under the spotlight as a commentary in the prestigious New England Journal of Medicine accuses the agency of seeming “timid and toothless."The article, by Dr. Susan Okie, a contributing editor to the journal, appears in the March 17 issue of the publication.The FDA and the drugs it approves have been under scrutiny for months. Two episodes have drawn particular attention to the agency. In September, the makers of the painkiller Vioxx removed the drug from the market following the revelation it had negative effects on the heart. And there has also been criticism of the FDA’s slowness in acknowledging studies linking adolescent use of antidepressants to an increased risk of suicidality.These controversies, Okie wrote, “have raised questions about the agency’s ability to fulfill one of its fundamental missions -- to ensure that the benefits of prescription drugs outweigh their risks."But, according to the article, the FDA’s problems go beyond this to include questions of post-marketing drug safety monitoring, lack of leadership, pressure to approve new drugs quickly and dubious ties to industry.It hasn’t always been this way, she said. “Earlier, it functioned as a pretty effective regulatory agency,” Okie said. “It had a much more watchdog posture vis-a-vis the pharmaceutical industry.”
