Do Slower Drug Approval Times Signal A ‘Cautious’ FDA?

Drug makers and industry analysts say that the FDA is "signal[ing] a "new caution" by initiating a "slowdown" in approving new drug applications. The Bloomberg News/Omaha World-Herald reports that the "median review time for drugs that are the first of their kind" increased last year for the first time in seven years, and this year the agency has approved only nine new drugs, compared to 16 at this point in 2000. Recently, Eli Lilly announced that the FDA will take three additional months to review the company's drug Xigris, "which trials suggest may be the first effective treatment for sepsis, an often fatal overreaction to infection." Other drugs that have been delayed by the agency include Schering-Plough's allergy medication Clarinex and Aventis SA's antibiotic Ketek. While new funding from Congress helped to shorten the FDA's median review time for new drugs from almost two years in 1990 to less than a year in 1999, analysts say that last year's withdrawals of Pfizer's diabetes drug Rezulin and GlaxoSmithKline's irritable bowel syndrome drug Lotronex, as well as the criticism of the agency's review process that accompanied them, have led the agency to proceed with greater caution. "For most of the FDA's history, you can make a strong case that the FDA has been very attentive to public opinion in the pace at which it approves new drugs," Greg Conko, a regulatory expert at the Competitive Enterprise Institute, said. In addition to the delays, the FDA last week turned down the approval of Novartis AG's irritable bowel syndrome drug Zelnorm, which analysts said had the "potential to generate peak sales" of up to $1 billion a year. "The FDA is very, very cautious these days," Joerg Reinhardt, Novartis' head of development, said.

John Jenkins, director of the FDA's pulmonary, metabolic and endocrinology drugs division, said that there is no "systematic" slowdown in approval times. He attributed the increased delays to the agency designating approvals for "priority review" at a lower rate in 2000 than in 1999 -- priority reviews average six months, while standard reviews average 10 to 12 months. Jenkins also said that a "backlog of applications from previous years" increased the average standard review time last year. Bloomberg/World-Herald reports that the lack of an FDA commissioner -- President Bush has not yet appointed someone to replace former Commissioner Jane Henney, who resigned in January -- may also be hindering the review process. "A headless FDA causes a bit of relaxation among the troops, which may in fact be resulting in a slight slowing of some approvals," Carl Feldbaum, president of the Biotechnology Industry Organization, said (Bloomberg/Omaha World-Herald, 6/25).