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FDA Vote Rejecting Studies of Antidepressants Underscores Need for Legislation Requiring Drug Studies

Wednesday, Oct. 26, 2005

FDA Panel Vote Rejecting Long-Term Studies of Antidepressants Underscores Need for Legislation Requiring Drug Studies
Post-Market Studies Wouldn’t Slow Flow of New Drugs to Market

(Washington, D.C.) — An FDA advisory panel’s decision to not require antidepressant makers prove their drugs work long-term before they are sold underscores the need for Congress to give the FDA authority to require drug companies conduct studies of their products once they are on the market.
“If the FDA had the power to require drug companies to study the safety and efficacy of their drugs once they are being used by millions of consumers, we would be able to avoid many of the problems we now face with dangerous drugs on the market,” said Rob Schneider, director of Consumers Union’s prescription drug safety campaign.
“Antidepressants already carry the strongest safety warnings due to their increased risk of suicide in children, yet the FDA has no power to require drug makers to study their long-term effects in those who take them. That just doesn’t make sense,” Schneider said.
An FDA advisory panel voted Tuesday to reject a new FDA policy requiring pre-approval “randomized withdrawal” trials for anti-psychotics and antidepressants, according to Inside Health Policy. These types of trials can prove long-term efficacy of a drug. But the panel echoed industry concern that requiring such pre-approval studies could delay approval of a drug by at least a year. It is expected the FDA will likely take the panel’s advice and not enforce the policy.
In October 2004, the FDA placed a “black box” warning on antidepressants because of increased risk of suicidal behavior in children and teens. Studies dating back to 1998 from the makers of Paxil discovered this link, yet those studies were never made public by the drug maker.
Two bipartisan bills introduced by Sens. Charles Grassley (R-Iowa) and Christopher Dodd (D-CT) would give the FDA effective authority to require post-market studies once safety problems arise with drugs on the market, as well as require drug makers to make public their clinical drug study results. The bills, introduced earlier this year, have yet to receive a hearing.
“Giving the FDA the power to require studies of drugs once they are on the market will do nothing to slow the flow of important, life-saving drugs to consumers. Rather, it will help ensure that the medicines we take each day are as safe as possible,” Schneider said.

Susan Herold, 202-462-6262