Online but unlawful sales of unapproved and misbranded prescription drugs: Internet pharmacy compliance with Food and Drug Administration warning letters

• Published date: 01 July 2023
• Author: Yam B. Limbu,Bruce A. Huhmann
• Date: 01 July 2023
• DOI: http://doi.org/10.1111/joca.12515

RESEARCH ARTICLE

Online but unlawful sales of unapproved and

misbranded prescription drugs: Internet

pharmacy compliance with Food and Drug

Administration warning letters

Yam B. Limbu

1

| Bruce A. Huhmann

2

1

Department of Marketing, Feliciano

School of Business, Montclair State

University, Montclair, New Jersey, USA

2

Department of Marketing, School of

Business, Virginia Commonwealth

University, Richmond, Virginia, USA

Correspondence

Bruce A. Huhmann, Department of

Marketing, School of Business, Virginia

Commonwealth University, 301 West

Main Street, Box 844000, Richmond, VA

23284-4000, USA.

Email: bahuhmann@vcu.edu

Abstract

Consumers increasingly use online pharmacies. How-

ever, illicit online pharmacies endanger consumer wel-

fare with unapproved and counterfeit drugs. By linking

Food and Drug Administration (FDA) warning letter

content with observations of the 1108 websites cited in

those letters, we identify factors associated with FDA-

requested compliance and active/inactive website sta-

tus. One in five online pharmacies failed to comply

with FDA recommendations. Findings support the

cost/benefit, social norm, and instrumental theories of

compliance. Compliance declines with cost (e.g., when

the FDA requests changes to more drug categories).

Organized crime's social norms encourage law break-

ing; thus, illicit pharmacies comply less than other

online pharmacies. Instrumental theory suggests per-

ceived severity and certainty of penalties influences

compliance. In support, when political will and atten-

tion focused on the opioid crisis, the FDA cited primar-

ily opioid-related violations and these opioid-related

letters increased compliance and website closures.

Finally, we recommend improved consumer protection

Received: 12 July 2022 Revised: 31 December 2022 Accepted: 29 January 2023

DOI: 10.1111/joca.12515

This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits

use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or

adaptations are made.

© 2023 The Authors. Journal of Consumer Affairs published by Wiley Periodicals LLC on behalf of American Council on Consumer

Interests.

J Consum Aff. 2023;57:1015–1038. wileyonlinelibrary.com/journal/joca 1015

efforts to address internet pharmaceutical distribution

challenges.

KEYWORDS

compliance theory, consumer protection regulation, Food and

Drug Administration policy, illicit online pharmacies, warning

letters

1|INTRODUCTION

Dispensing medications online poses regulatory challenges for consumer protection agencies

and regulators who monitor violations of consumer health and safety laws and policies. Online

pharmacies (also known as internet pharmacies, cyber pharmacies, or e-pharmacies) are any

entities that sell or dispense pharmaceutical drugs or other government-regulated medical treat-

ments through the internet or electronic media (e.g., websites, social media, or mobile apps).

Online pharmacies have experienced explosive growth due to the convenience, accessibility,

and cost-savings that they provide to consumers. Online pharmacies are now a large healthcare

resource for consumers with a global market valued at US$68 billion in 2021 and forecast to

reach US$206 billion annually by 2028, with a compound annual growth rate (CAGR) of 16.8%

(Global Market Insights, 2022). In the United States (U.S.), the US$52 billion online pharmacy

market is forecast to reach revenues of over US$146 billion by 2026, with a CAGR of approxi-

mately 19% (Arizton, 2021). A survey by Alliance for Safe Online Pharmacies (2020) found that

35% of American consumers have purchased medication from an online pharmacy for them-

selves or someone in their care. The COVID-19 pandemic has fueled further growth in online

prescribing and dispensing of medications.

Monitoring and investigating online pharmacies is difficult for consumer protection agen-

cies as many of these websites do not disclose their actual locations and the vast majority of

their website domain names are registered anonymously. U.S. pharmacies are typically regu-

lated at the state level, but the U.S. Food and Drug Administration (FDA) has gotten more

involved in regulating online pharmacies because their sales cross state lines and the FDA has

extraterritorial jurisdiction over imported drugs. Despite increased regulatory oversight by the

FDA, many online pharmacies have continued to violate industry standards, prompting the

FDA to issue warning letters to them. However, very little is known about the factors that influ-

ence their compliance with FDA recommendations or the status of their pharmacy websites fol-

lowing warning letter issuance. It is important to understand the nature and content of FDA

warning letters and observe pharmacy websites to document the determinants of more effective

consumer protection efforts through the use of regulatory warning letters. The present study

represents the first effort in addressing this issue.

Compliance with FDA warning letters is needed to effectively protect consumer welfare.

Therefore, the purpose of the current study is to identify the aspects of warning letters related

to greater compliance with FDA recommendations. This study combines a content analysis of

FDA warning letters issued to online pharmacies with a careful assessment to confirm their

compliance and the status of cited websites after receiving warning letters. Results test hypothe-

ses based on cost/benefit, social norm, and instrumental theories of compliance and provide

practical implications for consumer protection agencies and regulators, legitimate online

1016 LIMBU and HUHMANN