FDA Commissioner McClellan To Improve Enforcement of Rx Drug Ad Rules
New FDA Commissioner Dr. Mark McClellan yesterday said he plans to increase enforcement of federal regulations against "deceptive" pharmaceutical advertisements, the New York Times reports. McClellan said that the FDA will take "more aggressive" action against pharmaceutical companies that use "misleading" ads to market their products (Pear, New York Times, 12/12). Pharmaceutical companies spend about $2.7 billion per year on direct-to-consumer ads (USA Today, 12/12). Since 1997, the FDA has sent more than 88 letters to pharmaceutical companies concerning their ads. A report issued last week by the General Accounting Office found that several large pharmaceutical companies have "repeatedly disseminated misleading" ads for treatments even after the FDA cited them for violations (New York Times, 12/12). McClellan said, "We do have the authority and we intend to use it. We will not be afraid to go to court when necessary" (Kemper, Los Angeles Times, 12/12). He also said that the FDA will improve enforcement against "misleading claims" about the health benefits of some dietary supplements (New York Times, 12/12). In addition, McClellan said that the FDA must "take a fresh look" at the standards food companies must meet to make claims about their products' health benefits. "There is a lot of information out there that doesn't meet the ... standard but that still may be something I think a reasonable person would want to know," he said (Adams, Wall Street Journal, 12/12).
McClellan also said that he hopes to reduce approval times for new prescription drugs, generic treatments and medical devices. The FDA approval process for a new prescription drug takes more than one year. McClellan said, "We have some great opportunities to do better in drug approval times and in getting products that are safe and effective to market more quickly." In addition, McClellan said that he hopes to negotiate agreements with some hospitals and nursing homes to report adverse prescription drug and medical device events to the FDA "automatically and promptly" (New York Times, 12/12). He also said that he would take steps to address the nation's obesity problem and to help consumers make improved health care decisions (Los Angeles Times, 12/2). Further, McClellan said that he plans to improve the safety of the nation's food supply and approve new treatments and vaccines to address biological, chemical or radiological attacks (Neergaard, AP/Philadelphia Inquirer, 12/12).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.