Warning letters for direct-to-consumer advertising: a five-year retrospective analysis

Soundarya Rai, Garima Bansal, Akash Chimegave, Sandeep Maharaj, Manthan D. Janodia

Research output: Contribution to specialist publicationArticle


Background: Direct-to-consumer pharmaceutical advertising (DTCPA) is a ‘grey area’ that the Food and Drugs Administration (FDA) in the United States (US) regulates through the Centre for Drug Evaluation and Research (CDER). One of the purposes of DTCPA is to educate and empower patients via popular media such as television, radio, internet and other modes of communication. In order to protect public health, the FDA keeps a close watch on advertisements by pharmaceutical companies through its Office of Prescription Drug Promotion (OPDP). The OPDP is empowered to issue Warning Letters or Untitled Letters to pharmaceutical companies when promotional content violates advertisement regulations and guidelines issued by the FDA. The objective of the study reported here was to analyse and assess the Warning Letters issued by OPDP, and to identify variables leading to Warning Letters being issued to pharmaceutical companies. Methods: Data were collected from the Office of Prescription Drug Promotion (OPDP) available from the public FDA database. Analysis of Warning Letters issued to pharmaceutical companies for DTCPA was carried out from 1 January, 2015, to 31 December, 2019. Results: During the five-year study period, of 42 letters issued by OPDP, 13 were Warning Letters, and 29 were Untitled Letters. Most of the Warning Letters were issued to pharmaceutical companies for medicines to treat chronic conditions; of these, 39.1% of violations were related to misleading risk and claim presentation, and 38% used webpages for DTCPA. Conclusion: A total of 42 Warning Letters were issued by the OPDP during 2015-2019, with a total of 70 violations listed. Most violations were listed for misleading claims, minimisation of risk and false or misleading risk information, while websites and webpages were the most frequently listed medium of communication for the violations. Fair balance in pharmaceutical product promotion remains a challenge for the FDA.

Original languageEnglish
Specialist publicationRegulatory Rapporteur
Publication statusPublished - 2023

All Science Journal Classification (ASJC) codes

  • Pharmacy
  • Pharmacology, Toxicology and Pharmaceutics (miscellaneous)


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