Abstract
Introduction
In the United States, all pharmaceutical promotional activities must comply with regulatory standards set by the Food and Drug Administration (FDA); failure to comply may lead to receiving an FDA enforcement letter. Letters include details of the specific advertisement in violation, as well as the action that is required by the company to rectify the non-compliant promotion.
Objectives
The aim of this study was to determine trends in enforcement letters from the FDA to parties responsible for pharmaceutical promotion violations from 2005 to 2019.
Methods
A longitudinal trend analysis was conducted of FDA enforcement letters sent to pharmaceutical companies from 2005 to 2019 (n = 318). Publicly available enforcement letters released by the Office of Prescription Drug Promotion were accessed and analysed online through the Center for Drug Evaluation and Research, a part of the FDA. Variables analysed included number of letters by year, violation categories, venues, intended audience, drug age and company revenues. Publicly available revenue was the major source for company revenue information.
Results
The total number of enforcement letters significantly decreased over time. Violations concerning risk information were significantly more prevalent than all other violation categories. Online promotional materials were most frequently cited. Proportionally, larger companies received the majority of letters in earlier years of observation, and smaller companies in later years (2013–2019).
Conclusions
These trends are of value for industry and regulators alike in refining policy to ensure fair, balanced and meaningful information in pharmaceutical promotion. The frequency of violation letters has decreased in recent years; however, smaller companies have increasingly received the majority of letters. Small firms must increase their compliance around informing drug risk potential with balanced safety information across all promotional venues. Specifically, these findings are useful for pharmaceutical companies to direct educational efforts to promotional staff and their advertising agencies, especially regarding online advertising.
Similar content being viewed by others
References
U.S. Food and Drug Administration. About the Center for Drug Evaluation and Research. 2016. https://www.fda.gov/drugs/enforcement-activities-fda/warning-letters-and-notice-violation-letters-pharmaceutical-companies. Accessed 12 Aug 2020.
Kamal KM, Desselle SP, Rane P, Parekh R, Zacker C. Content analysis of FDA warning letters to manufacturers of pharmaceuticals and therapeutic biologicals for promotional violations. Drug Inf J. 2009;43:385–93.
Romanski JA, Capone KC. The Last Two Years: A Summary of 2014-2015 Office of Prescription Drug Promotion (OPDP) Enforcement and Relevant FDA Guidance. Porzio LifeSciences. 2016. https://s3-us-west-2.amazonaws.com/porzio/media/1497/the-last-two-years-a-summary-of-2014-2015-office-of-prescription-drug-promotion-opdp-enforcement-and-relevant-fda-guidance.pdf. Accessed 17 Jan 2020.
Limbu YB, McKinley C, Temperini V. A longitudinal examination of FDA warning and untitled letters issued to pharmaceutical companies for violations in drug promotion standards. J Consum Aff. 2019;53:3–23.
Sandburg B. Rx Promotion Citations by US FDA Plummet; UCLA Webpage Elicits Final Letter Of 2017. Pink Sheet, Pharma Intelligence Informa. 2018. https://pink.pharmaintelligence.informa.com/PS122371/Rx-Promotion-Citations-By-US-FDA-Plummet-UCLA-Webpage-Elicits-Final-Letter-Of-2017. Accessed 17 Jan 2020.
U.S. Food and Drug Administration. About FDA, transparency, number of core initial promotional campaigns completed in a month. https://www.accessdata.fda.gov/scripts/fdatrack/view/track.cfm?program=cder&status=public&id=CDER-RRDS-Number-of-campaign-material-reviews-completed&fy=2016. Accessed 21 Sep 2018.
Schwartz LM, Woloshin S. Medical marketing in the United States, 1997–2016. JAMA. 2019;321:80–96. https://doi.org/10.1001/jama.2018.19320.
Harvard Law Review. United States v. Caronia: Second Circuit Holds that Prohibiting Truthful Off-Label Promotion of FDA-Approved Drugs by Pharmaceutical Representatives Violates First Amendment. Harvard Law Review. 2013;127:795–802. https://harvardlawreview.org/wp-content/uploads/pdfs/vol127_united_states_v_caronia.pdf. Accessed 17 Jan 2020.
Greene JA, Kesselheim AS. Pharmaceutical marketing and the new social media. N Engl J Med. 2010;363:2087–9.
United States (U.S.) Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) Center for Veterinary Medicine (CVM) Center for Devices and Radiological Health (CDRH). Guidance for Industry Internet/Social Media Platforms with Character Space Limitations—Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices, Draft Guidance. U.S. Food and Drug Administration (FDA). 2014a. https://www.fda.gov/downloads/drugs/guidances/ucm401087.pdf. Accessed 17 Jan 2020.
U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) Center for Veterinary Medicine (CVM) Center for Devices and Radiological Health (CDRH). Guidance for Industry Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices, Draft Guidance. U.S. Food and Drug Administration. 2014b. https://www.fda.gov/downloads/drugs/guidances/ucm401079.pdf. Accessed 17 Jan 2020.
Davis JJ. Consumer preferences for the communication of risk information in drug advertising. Health Aff. 2007;26:863–70.
Sullivan HW, Campbell M. Do prescription drug ads tell consumers enough about benefits and side effects? Results from the Health Information National Trends Survey, Fourth Administration. J Health Commun. 2015;20:1391–6.
Betts KR, Boudewyns V, Aikin KJ, Squire C, Dolina S, Hayes JJ, Southwell BG. Serious and actionable risks, plus disclosure: investigating an alternative approach for presenting risk information in prescription drug television advertisements. Res Soc Adm Pharm. 2018;14(10):951–63.
Ziegler MG, Lew P, Singer BC. The accuracy of drug information from pharmaceutical sales representatives. JAMA. 1995;273:1296–8.
Author information
Authors and Affiliations
Corresponding author
Ethics declarations
Funding
None.
Declarations of conflicts of interest
The authors have no conflicts of interest to declare.
Availability of data and material
The data that support the findings of this study are available from the corresponding author upon reasonable request.
Code availability
Codes for this study are available from the corresponding author upon reasonable request.
Ethics approval
Not required—no human subject interaction. Public database only.
Consent to participate
No consent was required; data in public domain.
Consent to publish
All authors provide consent to publish.
Author contributions
KZ contributed to the conception, design and acquisition of data, analysis, interpretation of data, drafted the work, revising manuscript and approved the version to be published. NYS contributed to the acquisition of data, analysis, interpretation of data, revising manuscript and approved the version to be published. AP contributed to the acquisition of data, analysis, interpretation of data, revising manuscript and approved the version to be published. TS contributed to the acquisition of data, revision of work and approved the version to be published. TJW contributed to the supervision, conception, design, interpretation of data, revising manuscript and approved the version to be published.
Supplementary Information
Below is the link to the electronic supplementary material.
Rights and permissions
About this article
Cite this article
Zagrodney, K.A.P., Sheikhan, N.Y., Pinto, A. et al. Drug Advertising Violations: A Longitudinal Trend Analysis of FDA Enforcement Letters from 2005 to 2019. Pharm Med 35, 31–38 (2021). https://doi.org/10.1007/s40290-020-00370-9
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s40290-020-00370-9