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Drug Advertising Violations: A Longitudinal Trend Analysis of FDA Enforcement Letters from 2005 to 2019

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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.

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Authors and Affiliations

  1. Institute of Health Policy, Management and Evaluation (IHPME), University of Toronto, Toronto, ON, Canada

    Katherine A. P. Zagrodney & Theodore J. Witek Jr

  2. Dalla Lana School of Public Health, University of Toronto, 155 College Street, Toronto, ON, M5T 3M6, Canada

    Katherine A. P. Zagrodney, Natasha Y. Sheikhan & Theodore J. Witek Jr

  3. Michael G. DeGroote School of Medicine, McMaster University, 1280 Main Street West, Hamilton, ON, L8S 4L8, Canada

    Ashlyn Pinto

  4. University College London, Gower Street, London, WCIE 6BT, UK

    Tania Sheikhan

Authors
  1. Katherine A. P. Zagrodney
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  2. Natasha Y. Sheikhan
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  3. Ashlyn Pinto
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  4. Tania Sheikhan
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  5. Theodore J. Witek Jr
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Corresponding author

Correspondence to Theodore J. Witek Jr.

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Funding

None.

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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.

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No consent was required; data in public domain.

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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.

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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

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  • DOI: https://doi.org/10.1007/s40290-020-00370-9

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