FDA Commissioner McClellan Calls For Faster Drug Review, Increased Efficiency
Speeding market entry of safe medicines, hastening marketing of generic drugs, updating drug manufacturing standards, retaining FDA scientists and decreasing medical errors top new FDA Administrator Mark McClellan's "tentative agenda," Dow Jones Business News reports. McClellan, who was confirmed by the Senate last month as FDA head but has not yet officially taken over, was speaking yesterday at a Schwab Markets Washington Research Group conference in Washington, D.C. (Middleton, Dow Jones Business News, 11/6). Recently, pharmaceutical companies have decreased production of new drugs and have said that the FDA drug review process has delayed the launch of products on the U.S. market (Reuters News, 11/6). In fiscal year 2002, the FDA accepted 21 new product applications, down from 44 in 1997 (Dow Jones Business News, 11/6). "There are I'm sure a number of reasons responsible for the decline in (new drug) applications in recent years, and one of the things we can do to help address that is to make sure our approval process is working as efficiently as possible," McClellan said (Reuters News, 11/6). After Congress approved application fees for new drugs in 1992, the FDA was able to reduce drug review time from two years to 12 months because the fees allowed the agency to hire more staff members. However, by 2000, the average drug review time increased to about 15 months. McClellan said that the time increase might be because fewer drug companies are submitting applications, meaning that the agency did not collect as much in application fees and was unable to operate at the quicker pace. McClellan also said yesterday that the FDA would work with the pharmaceutical industry to implement a bar code system on prescription drugs to decrease medical errors and urged that a prescription drug benefit be added to Medicare (Dow Jones Business News, 11/6).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.