McClellan Raises Concerns About Purchase of Prescription Drugs From Canada, Other Nations
FDA Commissioner Dr. Mark McClellan on Monday "stepped up the agency's rhetoric" against legislation and other efforts that would allow the purchase of FDA-approved prescription drugs from Canada and other industrialized nations during a speech at the National Press Club, the Wall Street Journal reports (Wall Street Journal, 10/21). "People's health is put at risk when doctors and pharmacists ... are replaced by storefronts and bogus Internet sites that are there for private profit, not public health," McClellan said. "Until we find solutions that do not force Americans to make choices between safety and affordability, all of us involved in policy cannot rest," he added (Baker, Washington Times, 10/21). McClellan said that lawmakers who support bill that would allow the purchase of prescription drugs from other nations are "out of touch with the realities of keeping our drug supply safe, and the clear and present danger to America's drug supply that their bills would create." He said that the FDA does not "have the resources or authorities" to ensure the safety of imported prescription drugs, which he said could potentially be counterfeit, mishandled or not closely overseen by Canadian or U.S. regulators (Wall Street Journal, 10/21). The speech marks McClellan's "harshest criticism" of such legislation to date, according to the Times (Washington Times, 10/21). During the speech, McClellan also highlighted various anti-counterfeiting efforts that the FDA has planned or wants to pursue, the Journal reports. McClellan said that the agency would like to improve drug pedigrees, or documents that trace which companies handle a drug; introduce "enhanced methods to assure the legitimacy" of Internet drug sites and any storefronts that work with them; and improve monitoring for counterfeit drugs by creating an electronic system. In addition, McClellan said that there should be "a better division of the cost of drug development" between different nations, the Journal reports (Wall Street Journal, 10/21).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.