FDA To Reduce Review Times for New Treatments by 10%, Commissioner Mark McClellan Says
FDA Commissioner Dr. Mark McClellan yesterday in a speech to the Biotechnology Industry Organization said the agency is moving to reduce by 10% the median review time for new drugs over the next five years, the Wall Street Journal reports. McClellan said that review times for drugs on the standard track could be reduced from the current average of 18 months to 16 months. Further, McClellan said the current six-month review schedule for priority drugs, or medications for conditions that have no known treatments, could be reduced by one month or several weeks. McClellan added that the per-drug approval cost could be reduced by $12.8 million if the agency meets the new target review times (Wall Street Journal, 6/24). McClellan said, "We want to find ways to make the pipeline shorter and less risky, less costly and less burdensome." He added that the reduced approval times would not come at the expense of safety (Todd, Newark Star-Ledger, 6/24). McClellan's remarks reflect the FDA's ongoing efforts to ensure more "predictable and efficient" drug reviews, according to the Journal. The new target times are part of the agency's agreement with the White House Office of Management and Budget to a new performance benchmark in exchange for receiving millions of dollars in user fees from drug companies, the Journal reports (Wall Street Journal, 6/24).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.