October 25, 2005

FDA May Scrap Proposal for Long Term Psych Drug Testing

The Wall Street Journal reported today that Federal regulators will "likely scrap a plan to require drug makers to submit longer-term studies on how well proposed psychiatric drugs work as a condition of approval, following a unanimous vote against the idea by a panel of outside medical experts."

The Journal stated that "The pharmaceutical industry argued against requiring long-term efficacy studies before a drug is approved, saying it would delay the already lengthy process of developing new treatments. Representatives from several drug companies, including Merck & Co., Pfizer Inc. and GlaxoSmithKline PLC, testified against the FDA proposal"

Dr. Laughren (of the FDA) said the issue is that "many patients need to be on medication long-term and there is little guidance for clinicians on how to use drugs for the first few years they are on the market" however, these trials are typically done after a few years anyway.

Source: Wall Street Journal, FDA May Scrap Plan to Require
Longer Psychiatric Drug Tests


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