Topic > Regulatory Changes in Direct-to-Consumer Marketing of...

Direct-to-consumer (DTC) marketing of pharmaceutical products has grown from strength to strength over the past decade. The American public sees prescription drug advertisements for a wide range of medical conditions, including high cholesterol, depression, allergies, and erectile dysfunction. The Federal Food and Drug Administration (FDA) regulates the content of these advertisements. Critics have also argued that the ads gain undeserved public trust, are misleading and promote unnecessary use of prescription drugs for common problems associated with aging. Proponents counter that DTC ads help eliminate stigmas associated with certain medical conditions, give patients an active role in managing their healthcare, and encourage doctor/patient relationships. There have been calls for a ban on DTC pharmaceutical advertising, but the practice is protected by a company's free speech rights. Regulatory changes, particularly requiring the FDA to pre-approve marketing campaigns before they are released to the public, could be one way to appease naysayers while protecting drugmakers' rights to advertise to the average American consumer . The FDA was given the authority to approve the marketing of pharmaceutical products in the United States as a result of the Federal Food, Drug, and Cosmetic Act, passed in 1938 (FDA par 2). In the 1960s, the agency issued final regulations for prescription drug advertising, which stipulated that these advertisements must not be false or misleading, present a "fair balance" of information describing both the risks and benefits of a drug, include “material” facts to the advertised uses of the product, and include a “brief summary” that mentions each risk described in the product… half of the document… in the twentieth century.” American Journal of Public Health. May 2010. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2853635/. Network. April 8, 2014. Ventola, C. Lee. “Is direct-to-consumer advertising therapeutic or toxic?” Pharmacy and therapy. October 2011. www.ncbi.nlm.nih.gov/pmc/articles/PMC3278148/#b5-ptj3610669. Network. April 5, 2014.Almasi, EA. “What are the public health effects of direct-to-consumer drug advertising?”.PLoS Med. March 2006 http://www.ncbi.nlm.nih.gov/pubmed/1656304. Network. April 5, 2014.Lyles, Adam. “Direct Marketing of Pharmaceutical Products to Consumers.” Annual Review of Public Health, Volume 23. 2002. Print.Auton, Frank. “Opinion: The Case of Advertising Pharmaceutical Products Directly to Consumers.” Pharmaceutical chemistry of the future. July 2009. http://www.ncbi.nlm.nih.gov/pubmed?term=Auton%20F%5BAuthor%5D&cauthor=true&cauthor_uid=21426028. Network. April 20 2014.