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
References
Nov 20, 2004·Medical Care·Julie M DonohueRichard G Frank
Mar 15, 2005·Journal of Health Communication·Erica D BrownfieldRuth M Parker
Mar 15, 2005·Journal of Health Communication·Kimberly A KaphingstLawren H Daltroy
Apr 28, 2005·JAMA : the Journal of the American Medical Association·Matthew F Hollon
Aug 4, 2005·Quality & Safety in Health Care·S GilbodyI Watt
May 9, 2006·The American Journal of Cardiology·Sunil V RaoUNKNOWN American College of Cardiology National Cardiovascular Data Registry
Nov 14, 2006·The Milbank Quarterly·Julie Donohue
Aug 19, 2007·The New England Journal of Medicine·Julie M DonohueMeredith B Rosenthal
Oct 31, 2007·Health Communication·Wendy MaciasLiza Stavchansky Lewis
Apr 19, 2008·The New England Journal of Medicine·Aaron S Kesselheim, Jerry Avorn
Aug 19, 2011·American Journal of Law & Medicine·Aaron S Kesselheim
Aug 23, 2011·PloS One·Deborah KorensteinJoseph S Ross
Mar 21, 2012·Annual Review of Public Health·Barbara Mintzes
Apr 12, 2012·Health Affairs·Joshua N MirkinElena B Elkin
Aug 30, 2013·The New England Journal of Medicine·Joseph S Ross, Aaron S Kesselheim
Sep 14, 2013·Journal of General Internal Medicine·Adrienne E Faerber, David H Kreling
Dec 30, 2014·SAGE Open Medicine·Kathleen A McManusRebecca Dillingham
Dec 18, 2015·International Journal of Health Policy and Management·Hyosun Kim
Feb 3, 2016·JAMA Internal Medicine·Amy Kapczynski
Feb 20, 2016·Journal of Medical Internet Research·Crystal Adams
Nov 8, 2016·JAMA Internal Medicine·Jeanie Kim, Amy Kapczynski
Mar 23, 2017·JAMA : the Journal of the American Medical Association·J Bradley LaytonSherry L Emery
May 4, 2017·BMJ : British Medical Journal·Tyler Greenway, Joseph S Ross
Jul 24, 2018·Bone & Joint Research·M ShabestariI K Haugen
Nov 1, 2017·Nature Human Behaviour·Niro Sivanathan, Hemant Kakkar
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
Jul 15, 2020·Journal of General Internal Medicine·Cole WayantMatt Vassar
Apr 8, 2020·Patient Preference and Adherence·Maram AlShammariYazed AlRuthia
Jan 24, 2021·Journal of General Internal Medicine·Jessica R CataldiAllison Kempe
Apr 6, 2021·JAMA Network Open·Ariel R GreenNancy Schoenborn