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FDA Panel Rejects Requiring Longer-Term Studies for Psychiatric Drugs

Kaiser Network

October 26, 2005

An FDA advisory committee on Tuesday voted 12-0 to recommend against a requirement that pharmaceutical companies conduct longer-term efficacy studies on some psychiatric medications before the drugs reach the market, the Wall Street Journal reports. The committee voted against the requirement for treatments for major depressive disorder but did not vote on other conditions. According to the committee, FDA officials should consider each condition separately before they implement a "one-size-fits-all" requirement for psychiatric medications. FDA officials have considered whether to implement the requirement for antidepressants, antipsychotics and other treatments for psychiatric conditions. FDA currently requires pharmaceutical companies to conduct short-term studies on psychiatric medications prior to approval, and companies in some cases conduct longer-term studies after the treatments reach the market (Corbett Dooren, Wall Street Journal, 10/26). 

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Thomas Laughren, acting FDA director of psychiatry products, said the agency likely will follow the recommendations of the committee (Groppe, Indianapolis Star, 10/26). Laughren said, "In fairness, these trials generally are done. The issue here is whether or not it's acceptable for the clinical community to wait two or three or four years for those results" (Wall Street Journal, 10/26). Pharmaceutical company officials, academic researchers and patient advocates argued against requiring longer-term efficacy studies on psychiatric medications because such research would delay approval of new treatments, increase costs, provide a small amount of new information and might not apply to all patients. "I believe the public interest is not served by this requirement, and it would cause a lot more harm and confusion than benefit," Harvard University researcher Gary Sachs said. Sachs added that, although longer-term efficacy studies on psychiatric medications are valuable, public research institutes should conduct them because of their complex design and requirements (Vedantam, Washington Post, 10/26).