FDA panel says approval for new depression drugs needs to be faster

Oct 26 2005

According to a Food and Drug Administration (FDA) advisory panel, drug makers seeking U.S. approval of new drugs to treat major depression should not be required to first provide data on how well they work long-term.

It seems that the FDA is considering calling for preliminary data on how well psychiatric drugs work long term before it approves them.

The agency usually follows the advice of its advisory panels.

But though the panel agreed long-term data could help doctors treat patients, it voted unanimously against new requirements, aligning themselves with patients and industry representatives who are concerned about the slow delivery of new medicines.

Panel chairman Dr. Wayne Goodman, head of psychiatry at the University of Florida's College of Medicine, agrees that more data is needed on long-term efficacy but feels a long-term requirement is the wrong approach as it would hurt consumers rather than help them.

Antidepressants have been closely scrutinised during the past few years, especially concerning their use among children and teenagers, and concern as to how the public would react to their decision amid such safety concerns, prompted the panel to take a second unanimous vote to support joint efforts between the industry and government agencies to study how the drugs work over time in order to help doctors.

FDA officials say they have recently begun to take a closer look at their approval requirements.

Dr. Thomas Laughren, acting director for the FDA's psychiatry products division, says the agency usually requires the collection of long-term efficacy data after it grants conditional approval, and most companies provide it, but there are sometimes delays.

Laughren says the agency already asks for long-term safety data prior to making its decision.

She says the process is already quite slow.

According to Susan Vogel-Scibilia of the National Alliance for the Mentally Ill, demanding more data would have the affect of slowing an already encumbered process.

She says the process is already quite slow.

Panelists said they understood the difficulties the FDA faced in getting long-term data after a drug is on the market, but suggested the agency consider other ways to ensure compliance other than making it a pre-approval requirement.