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FDA calls on physicians to report misleading drug ads

The Food and Drug Administration wants physicians' help monitoring deceptive or misleading pharmaceutical advertising or promotional efforts. The agency's Division of Drug Marketing, Advertising and Communications in May unveiled the Bad Ad Program, an initiative aimed at getting doctors, pharmacists, nurse practitioners and physician assistants to report drugmaker violations of marketing rules. "The Bad Ad Program will help health care providers recognize misleading prescription drug promotion and provide them with an easy way to report this activity to the agency," said Thomas Abrams, director of the FDA's drug marketing division. The agency's staff tracks what drugmakers say in advertisements, pamphlets and medical meetings, but has little ability to monitor what detailers or company-sponsored speakers say in private when promoting pharmaceuticals. The FDA said reportable marketing violations include when detailers or company-sponsored speakers: * Omit information about risks. * Overstate drugs' effectiveness. * Compare drugs in misleading ways. * Promote unapproved uses. Pharmaceutical Research and Manufacturers of America Senior Vice President Ken Johnson said he views the initiative as "another step to help educate -- and receive feedback from -- health care providers about prescription drug advertising and promotion." He said drug advertising and promotion "can provide great value to patient care and the U.S. health care system," and drugmakers already devote a lot of time and effort to ensuring that their communications are accurate and legal. However, the FDA initiative comes on the heels of a series of big-money payouts by drugmakers for off-label promotions. In April, AstraZeneca plc said it struck a $520 million settlement with the federal government over allegations that it illegally marketed the atypical antipsychotic Seroquel, though the company admitted no wrongdoing. Pfizer Inc. paid a record-breaking $2.3 billion in criminal fines and lawsuit settlements in September 2009 in connection to its promotion of the COX-2 inhibitor Bextra. Pfizer admitted to limited misstatements but denied the bulk of the allegations. At this article's deadline, the FDA said it planned to distribute educational materials about the Bad Ad Program at May and June meetings of the American Psychiatric Assn., American Urological Assn., American Academy of Physician Assistants, American Society of Clinical Oncology, Endocrine Society, and American Academy of Nurse Practitioners. More information about the program is available at the FDA website ( Physicians and other health professionals can report potential drug promotion violations by calling 877-RX-DDMAC or by e-mail ( The full and original article can be found here:
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