FDA Panel Opposes Long-Term Efficacy Studies for Psychiatric Drugs

An FDA advisory committee on Tuesday voted 12-0 to recommend against a requirement that pharmaceutical companies conduct long-term efficacy studies on some psychiatric medications before approval, 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 (Corbett Dooren, Wall Street Journal, 10/26).

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 long-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.

Harvard University researcher Gary Sachs said, "I believe the public interest is not served by this requirement, and it would cause a lot more harm and confusion than benefit." Sachs added that, although long-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).