BOSTON – A study published this week in the New England Journal of Medicine found that prescription drugs approved by the U.S. Food and Drug Administration shortly before the deadline for deciding on new drug applications are more likely to have safety issues than drugs that are scrutinized longer.
The Prescription Drug User Fee Act allows the FDA to collect fees from drugmakers. But it also comes with performance targets for the agency, which has been under pressure for years to speed up the process of vetting new drugs so they can be made available to the public.
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Since January 1993, the FDA has operated under self-imposed deadlines, and it currently promises to reach a decision on 90 percent of new drugs within 10 months, and within six months for “priority” drugs. That schedule has sharply reduced review times over the years.
The new study – led by Daniel Carpenter, a professor of government at Harvard University – researchers found that of the 313 drugs the FDA approved between 1993 and 2004, 97 were approved within two months of the deadline.
Those 97 drugs had a 14-percent rate of severe safety problems, compared with 3 percent for the other 216 drugs.
In addition, drugs approved near the deadline were more than four times as likely to be withdrawn because of safety issues, require a “black-box” warning or be voluntarily taken off the market, the study found. Of the 21 drugs that have been withdrawn or given black-box warnings since 1993, 14 were approved within two months of the deadline.
In an interview with the Wall Street Journal, Carpenter said it’s impossible to make a direct connection between the deadlines and specific safety problems, but he suggested that tying user fees to these deadlines was a good idea. “Congress would be much better off relying less upon these deadlines and relying more on a big increase in full-time employees,” he told the newspaper.
