Medical advertising laws & regulations
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Comments of Sidney M. Wolfe, MD Larry D. Sasich, Pharm. D., MPH Public Citizen Health Research Group Allison M. Zieve David C. Vladeck Public Citizen Litigation Group Washington DC Public Citizen submits these comments to address some of the issues raised in comments submitted in response to the FDA Notice dated May 16, 2002 and to discuss the broader issues concerning the critical importance of rapidly diminishing FDA enforcement of drug advertising laws and regulations. We begin with a brief discussion of the nature of advertising and FDA enforcement actions with regard to advertising. We then address promotion of products for unapproved uses, including promotion of products never approved for any use. ADVERTISING OVERVIEW Of course, the purpose of advertising and promotion is to sell products. And maximizing the positive aspects of drugs and medical devices and minimizing the negative in advertisements is the best way to convey to the public and to health professionals that the benefits outweigh the risks, even if the balance is exaggerated. More : accessmylibrary.com |