title: Problems associated with direct-to-consumer advertising (DTCA) of restricted, implantable medical devices: should the current regulatory approach be changed?
abstract: Advertising and promotion of Food and Drug Administration (FDA)-approved medical products has been one of the most controversial and bitterly litigated areas in food and drug law in the U.S. for more than a decade. Hundreds of newspaper articles and dozens of law review articles have been written on the subject of the risks and benefits of direct to consumer advertising (DTCA) of medical products, but until very recently virtually all of this literature and commentary has focused exclusively on prescription and over-the-counter drugs. Even when FDA has sponsored public hearings to address the issue of DTCA of all medical products, as it did in 2005, review of the content of the speakers' presentations reveals that almost all of the subject matter, nearly all of the data, and the majority of comments concerned DTCA of drugs. Not a single law review article has ever been devoted exclusively to the subject of advertising and promotion of medical devices to consumers--until now.
authors.affiliation: Health Law & Policy Group, University of Houston Law Center, Houston, TX, USA.
authors.forename: Bruce
authors.initials: B
authors.lastname: Patsner
mesh_terms: D000329:Advertising / Q000331:legislation & jurisprudence* / Q000592:standards; D003256:Community Participation / Q000331:legislation & jurisprudence*; D018795:Device Approval / Q000331:legislation & jurisprudence*; D054855:Drug-Eluting Stents; D004869:Equipment Safety; D033161:Government Regulation; D006801:Humans; D008389:Marketing of Health Services / Q000331:legislation & jurisprudence*; D056687:Off-Label Use; D010353:Patient Education as Topic; D010358:Patient Participation / Q000331:legislation & jurisprudence*; D010819:Physician's Role; D019736:Prostheses and Implants; D012380:Role; D014481:United States; D014486:United States Food and Drug Administration