Do Quick Approvals Mean Risky Drugs?
Posted on: Friday, 27 June 2008, 06:01 CDT
By Dickinson, James G
THE FDA SAYS it has found at least two fundamental problems with data in a Harvard study, found in the New England Journal of Medicine, that showed drugs approved close to their Prescription Drug User Fee Act (PDUFA) deadline are more likely to have post- market safety problems than other drugs. The study, from researchers at Harvard Medical School and Brigham and Women's Hospital, noted that their findings "are not consistent with" FDA analyses in 2005 that "showed no increase in problems after the user-fee system was introduced." Using "dynamic Cox proportional-hazards models of review times for all new molecular entities approved between 1950 and 2005" and "exact logistic regression" to determine the effect of deadlines, the authors concluded that the deadlines "have appreciably changed the approval decision of the FDA. Once medications are in clinical use, the discovery of safety problems is more likely for drugs approved immediately before a deadline than for those approved at other times."
A study found PDUFA deadlines coincide with drug safety issues
If a safety problem is not detected during the initial preapproval evaluation, the authors wrote, "it may not be fully defined or included as a prominent warning for years afterward, as occurred with the risks of potentially fatal drug-drug interactions with mibefradil (Posicor, Roche) and terfenadine (Seldane, Hoechst Marion Roussel), myocardial infarction or stroke with rofecoxib (Vioxx), hepatotoxicity with troglitazone(Rezulin, Warner-Lambert), and rhabdomyolysis with cerivastatin (Baycol, Mayer AG)."
The authors suggested that appropriations-funded staff increases are an effective a way of accelerating regulatory processes as user fees. "A plausible hypothesis is that relying more on staffing and less on deadlines could result in the same degree of review efficiency."
"We don't think their conclusions hold up," FDA associate commissioner for public affairs Julie Zawisza said in an email. "It's also important to note that nearly all drugs are approved near their PDUFA date, not just drugs in which subsequent safety problems have emerged."
-James G. Dickinson
Copyright Haymarket Media, Inc. Jun 2008
(c) 2008 Medical Marketing and Media. Provided by ProQuest Information and Learning. All rights Reserved.
Source: Medical Marketing and Media
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