Direct-to-Consumer Broadcast Advertisements for Pharmaceuticals: Off-Label Promotion and Adherence to FDA Guidelines

Journal of General Internal Medicine
Kristina KlaraJoseph S Ross

Abstract

Direct-to-consumer (DTC) advertisements for prescription drugs in the United States are regulated by the Food and Drug Administration (FDA). Off-label promotion, or the advertisement of a drug for an indication not approved by the FDA, is prohibited. Our objective was to examine the presence of off-label promotion in broadcast DTC ads and to assess their adherence to FDA guidelines mandating fair balance in presentation of risks and benefits and prohibiting misleading advertisement claims. All English-language broadcast DTC ads for prescription drugs that aired in the United States from January 2015 to July 2016 were obtained from AdPharm, an online collection of healthcare advertisements. Ad length was measured and adherence to FDA guidelines was assessed for several categories: key regulatory items, indicators of false or misleading ads, and indicators of fair balance in presentation of risks and benefits. Our sample included 97 unique DTC ads, representing 60 unique drugs and 67 unique drug-indication combinations. No ads described drug risks quantitatively, whereas drug efficacy was presented quantitatively in 25 (26%) ads. Thirteen (13%) ads, all for diabetes medications, suggested off-label uses for weight loss and blood ...Continue Reading

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Citations

Feb 10, 2018·Journal of General Internal Medicine·Natasha Parekh, William H Shrank
Jan 9, 2019·JAMA : the Journal of the American Medical Association·Lisa M Schwartz, Steven Woloshin
Mar 5, 2019·Australian and New Zealand Journal of Public Health·Neda Khalil ZadehJames A Green
Aug 8, 2018·Issues in Mental Health Nursing·Jacquelyn H Flaskerud
May 24, 2019·Journal of Translational Medicine·Salma JamalAbhinav Grover
Feb 26, 2020·Journal of General Internal Medicine·So-Yeon KangGerard F Anderson
Jan 24, 2021·Journal of General Internal Medicine·Jessica R CataldiAllison Kempe

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