ArticleJournal of general internal medicine2018
Direct-to-Consumer Broadcast Advertisements for Pharmaceuticals: Off-Label Promotion and Adherence to FDA Guidelines.
Article in Journal of general internal medicine, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.
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Who cites it
9 citing papers in PubMed, 34 citations in OpenAlex.
- Content Analysis of Promotional Materials for Prescription Drugs Authorized Under Emergency Use Authorization.Drug safety · 2026Article
- Aligning Medications With What Matters Most: Conversations Between Pharmacists, People With Dementia, and Care Partners.Journal of the American Geriatrics Society · 2025Article
- Misleading Advertising of Health-Related Products in Ecuador during the COVID-19 Pandemic.Diseases (Basel, Switzerland) · 2022Article
- Sodium-glucose co-transporter-2 inhibitors in patients with type 2 diabetes: Barriers and solutions for improving uptake in routine clinical practice.Diabetes, obesity & metabolism · 2022Review
- Use of High-Dose Influenza and Live Attenuated Influenza Vaccines by US Primary Care Physicians.Journal of general internal medicine · 2021Article
- Assessment of Patient-Preferred Language to Achieve Goal-Aligned Deprescribing in Older Adults.JAMA network open · 2021Article
- Off-Label Coverage of High-Cost Drugs by Independent Charity Patient Assistance Programs.Journal of general internal medicine · 2021Article
- The Impact of Direct-to-Consumer Pharmaceutical Advertising on Public Knowledge of Gastroesophageal Reflux Disease: A Study on Over-the-Counter Proton Pump Inhibitors.Patient preference and adherence · 2020Article
- Dangers and Opportunities of Direct-to-Consumer Advertising.Journal of general internal medicine · 2018Article
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Authors and funding
3 authors at 1 institution in 1 country.
Funding
Abstract
backgroundDirect-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.
methodsAll 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.
resultsOur 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.
conclusionsFew 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.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.