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J Gen Intern Med. 2018 Feb 26. doi: 10.1007/s11606-017-4274-9. [Epub ahead of print]

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

Klara K1, Kim J2,3, Ross JS4,5,6,7.

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Yale School of Medicine, New Haven, CT, USA.
Yale Law School, New Haven, CT, USA.
Collaboration for Research Integrity and Transparency (CRIT) at Yale University, New Haven, CT, USA.
Collaboration for Research Integrity and Transparency (CRIT) at Yale University, New Haven, CT, USA.
Section of General Internal Medicine and the National Clinician Scholars Program, Yale School of Medicine, New Haven, CT, USA.
Department of Health Policy and Management, Yale School of Public Health, New Haven, CT, USA.
Center for Outcomes Research and Evaluation (CORE), Yale-New Haven Hospital, New Haven, CT, USA.



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 pressure reduction. The most commonly advertised drugs were indicated for the treatment of inflammatory conditions (n = 12; 18%), diabetes or diabetic neuropathy (n = 11; 16%), bowel or bladder dysfunction (n = 6; 9%), and infections or allergic reaction (n = 6; 9%). More than three-quarters (n = 51; 76%) advertised drugs to treat chronic conditions.


Few broadcast DTC ads were fully compliant with FDA guidelines. The overall quality of information provided in ads was low, and suggestions of off-label promotion were common for diabetes medications. The impact of current DTC ads and off-label marketing on patient and prescriber decisions merits further scrutiny.


FDA guideline adherence; direct-to-consumer advertising; off-label marketing; off-label promotion; pharmaceutical promotion


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