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Commentary

Benefits of a Brisk FDA
Boston Herald, 10-22-06

The Herald notes that economic research suggests that legislative efforts in the early 1990s to speed up drug reviews at the FDA has saved lives, even after accounting for additional safety risks that may accrue to the faster marketing of new drugs.

For years analysts noted that FDA bureaucrats get roasted in cases like Vioxx but are never criticized for holding up approval of drugs that could benefit sick people. The 1992 law was an attempt to speed decisions and seems to have succeded. The median approval time in 1997–2002 was 12 months vs. 27 months in 1979–1986.

A new paper from the National Bureau of Economic Research (by Tomas J. Philipson of the University of Chicago, Ernst R. Bendt of MIT, Adrian Gottschalk of Biogen Idec Inc. and Matthew Strobeck of Westfield Capital) concludes that the benefits of faster decisions have far outweighed the costs of letting unsafe drugs on the market.

In studying 662 drugs approved from 1979 to 2002, the researchers made very conservative assumptions: that withdrawn drugs gave no benefit to anyone receiving them, that without the 1992 legislation the FDA would never have approved the withdrawn drugs and that all who died after receiving them would have lived out their life expectancies.

They concluded that the withdrawn drugs cost patients 56,000 years of life at most, but approved drugs had added 180,000 to 310,000 years of life. In other words, the benefits of faster approvals are roughly three to five times the costs.

The authors believe their techniques should be more widely used. "Despite the agency's strict adherence to evidence–based evaluation of products overseen, there is less evidence of its own safety and efficacy," they wrote. "Put differently, no product application would pass the FDA approval process with the quality and type of evidence that currently exists for evaluating the FDA policies themselves." Good idea. And the 1992 law should be renewed when it comes up again in 2008.



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