Implied Claims in Drug Advertising: A Review of Recent Literature and Regulatory Actions

ABSTRACT

Federal agencies and self-regulatory bodies help to ensure prescription and nonprescription drug promotion contains accurate information; however, false or misleading claims may cause people to have inaccurate perceptions of a drug and inhibit their ability to make informed decisions. We conducted a systematic review assessing evidence from 2012–2021 on how consumers and healthcare providers (HCPs) interpret claims made indirectly or through inference (implied or implicit claims) as well as synthesizing prescription and nonprescription drug advertising claims that have been the subject of regulatory actions from 2017–2021. Our search identified 16 studies from the peer-reviewed literature and 26 letters or case reports issued by the Food and Drug Administration (FDA) or National Advertising Division (NAD). Results from peer-reviewed studies suggest that implied claims can result in inferences that may not be warranted by the material facts about the drug. Perceptions of a drug’s efficacy and, to a lesser extent, risk, are influenced by implied and explicitly false claims in prescription drug promotion. Claims related to implied superiority and overstatement of efficacy were the most prevalent claims flagged for review and examined in the literature. These types of claims were also the subject of many of the compliance actions by the FDA and case reports from the NAD. More research is needed to understand how people interpret varying types of implied claims and the impact of such claims on key outcomes. From a policy standpoint, understanding how people interpret implied claims can inform how the FDA approaches these claims in the marketplace.

Disclosure statement

No potential conflict of interest was reported by the authors.

Supplementary data

Supplemental data for this article can be accessed online at https://doi.org/10.1080/10410236.2023.2179717.

Notes

1. The compliance letters and case reports were limited to the past 5 years to focus on more recent actions by regulatory bodies and to reflect current marketing trends. No FTC warning letters fit our inclusion criteria during that time frame so we limited our analysis to FDA and NAD.

2. The BBB National Programs’ National Advertising Division (NAD) and its appellate body, the National Advertising Review Board, are the U.S. advertising industry’s self-regulatory bodies that provide dispute resolution services. The NAD reviews advertising based on challenges from businesses, its own initiative, or complaints from consumers. A team of NAD attorneys reviews the advertising or packaging claims and provides final advertising claim substantiation decisions.

3. Although the authors did not classify the claims as such, the Othman study included comparative claims with unnamed price statements (“most cost effective”), unnamed comparisons of dosing (“better compliance as once daily dosage”), mechanism of action (MoA) claims (“The medicine has the highest ability to activate receptors at the therapeutic dose”), unnamed comparative risk claims (“Less side effects”), and named comparative efficacy claims (“superior than Viagra”).

Additional information

Funding

Funding was provided by the Office of Medical Policy, Office of Prescription Drug Promotion, Center for Drug Evaluation and Research, U.S. Food and Drug Administration. Drs. Aikin and Betts are employed by the funder. Micaela Brewington is now at the University of North Carolina but completed this work while at RTI. This article reflects the view of the authors and should not be construed to represent FDA’s view or policies.