October 20, 2005

FDA: Long-term studies before approving Meds?

FDA officials are considering requiring drug manufacturers to conduct longer-term studies of psychiatric medications, such as antidepressants, antipsychotics and other treatments for long-term psychiatric conditions, the Wall Street Journal reports.

FDA now requires short-term clinical studies that typically last three months to be completed prior to approval, and drug companies sometimes conduct long-term research, which can take two to three years, after drugs reach the market.

Documents posted on the FDA Web site state that the agency has been asking for "longer-term efficacy data" on antidepressants for the past six months, the Journal reports. Thomas Laughren, acting director of FDA's division of psychiatry products, said the agency has been considering such a requirement for a long time, prompted in part by the limited data that were available during last year's debate over increased suicide risks in teenagers taking antidepressants.

Some manufacturers and researchers said that requiring longer-term studies before approval will hinder the drug development process.

"If you require that chronic studies be done prior to filing a new drug application, you have potential to delay the approval of new drugs significantly. That has implication for patients," David Michelson, executive director for neuroscience medical research at Eli Lilly, said. The change likely would not increase costs for the industry by too much, Michelson added. An FDA advisory committee will meet Oct. 25 to discuss the change and decide how to design the long-term trials. Representatives from drug companies intend to testify at the meeting


Post a comment

Please enter this code to enable your comment -
Remember Me?
(you may use HTML tags for style)
* indicates required