U.S. Congress rethinking drug-approval policy
Washington Post likens Congress’ suggestion to “chasing the horses after they are out of the barn”
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A July 5, 2007 article in the Washington Post asked questions about the long-term effects of the Prescription Drug User Fee Act of 1992, a piece of legislation originally aimed at getting innovative and highly beneficial drugs to market more rapidly. Fifteen years later, the result may be drugs raced through clinical trials and into the market, where consumers are now suffering. The Post cited three drugs in particular: Vioxx, Ketek and Avandia.
In the decade after 1993, the average approval time for standard drugs went from 22 months to 14, and “priority” drugs decreased from 13 months to six. But now, in the middle of 2007, the U.S. Congress is rethinking the 1992 act. Among the options facing the legislature is increasing the fees and devoting them to “post-market surveillance.”
The Post equated post-market surveillance to someone trying to chase horses once they leave the barn.
“I am deeply disappointed in the way things are headed,” Jerry Avorn, a Harvard Medical School physician, said. “This is our last chance to get it right before five more years go by.”
Source: David Brown, “Congress Seeks to Balance Drug Safety, Quick Approval,” Washington Post, July 5, 2007.

