backIn 2022, the U.S. Food and Drug Administration (FDA or the Agency) issued a total of nine enforcement letters targeting advertising and promotion violations for prescription drugs and devices. A summary of the noteworthy trends and issues spotted in these letters is outlined below.
NOTABLE PRESCRIPTION DRUG ENFORCEMENT TRENDS IN 2022
Of the nine total advertising and promotion letters in 2022, four were issued by FDA’s Office of Prescription Drug Promotion (OPDP). Of these four, one was a Warning Letter and three were Untitled Letters. The OPDP letters mark the lowest number seen since 2010, continuing the more than decade-long decline in volume of enforcement letters.
• Most Commonly Cited Violations: Of the four letters, one cited misbranding of an investigational new drug, while the remaining three letters all cited violations of false or misleading risk presentation and false or misleading benefit presentation.
- Misbranding of an Investigational Drug (Pre-approval Promotion) – In its only Warning Letter of the year, OPDP continued its focus on and enforcement against misbranding and pre-approval promotion of investigational drugs. See Leronlimab Warning Letter. In this instance, FDA had previously cautioned in a public statement that CytoDyn’s data on leronlimab, an investigational drug, did not support the clinical benefit of the drug for the treatment COVID-19. Yet, four months later, the company’s CEO was featured in a video interview mischaracterizing clinical data and making claims that promoted leronlimab as safe and effective for COVID-19, thus prompting OPDP’s Warning Letter.
- False or Misleading Risk Presentations – The following summarizes the range of OPDP objections for false or misleading risk presentations:
- Lack of fair balance – Lack of fair balance was cited in across a variety of promotional materials, including print pieces, websites, and social media posts. In particular, OPDP routinely flags when promotional materials fail to present information relating to risks with a prominence and readability reasonably comparable with the presentation of benefits. See e.g., Roszet Untitled Letter. In two letters, a lack of fair balance was exacerbated by the simultaneous presentation of risk and benefit information in video formats, creating competing and distracting sets of information that limited viewer comprehension. See, e.g., Duobrii and Trulicity Untitled Letters. Notably, this issue has come up in recent years in the context of direct-to-consumer television ads and social media or website videos, signaling OPDP’s increasing focus on fair balance in video formats.
- Omission of material risk information – Two letters challenged promotional materials for failing to disclose important risks associated with the use of the advertised product. For example, a social media post for Trulicity failed to include a warning about increased risks of hypoglycemia when the product is used concomitantly with insulin. See Trulicity Untitled Letter.
- Misleading imagery in patient videos – In the Duobrii Untitled Letter, the failure to include information about serious risks to the fetus and for photosensitivity/sunburn was made worse with imagery showing a female patient of child-bearing age (alongside two young children) and wearing clothing that exposes her shoulders and arms. See e.g., Duobrii Untitled Letter.
- False or Misleading Benefit Presentations – The following summarizes the range of OPDP objections for false or misleading benefit presentations:
- Unsubstantiated efficacy claims – In two letters, OPDP challenged claims based on studies that were not designed to support conclusions about product efficacy. For example, efficacy claims for Roszet were based on retrospective calculations of pooled data from two unrelated studies that did not even evaluate Roszet. Further, study limitations precluded efficacy conclusions due to potential for a Type I error and lack of control for multiplicity testing, among others. See Roszet Untitled Letter; see also Duobrii Untitled Letter (challenging efficacy claims and conclusions based on a post hoc analysis for which there was no prespecified statistical procedure controlling for type 1 error rate).
- Misleading superiority claims – In one letter, OPDP cited as misleading express claims of “superior efficacy” and additional claims made by a patient spokesperson suggesting that the product is clinically superior to other products. In both instances, the Agency noted the lack of available data to support such claims. See Duobrii Untitled Letter.
- Omission of material fact – In two letters, OPDP challenged as misleading product claims that failed to adequately communicate the indication and/or limitations of use associated with the product. See e.g., Trulicity and Roszet Untitled Letters.
NOTABLE DEVICE ENFORCEMENT TRENDS IN 2022
Of the nine total letters issued in 2022, five were related to medical device advertising and promotion violations. These were sent by FDA’s Office of Product Evaluation and Quality (OPEQ), within the Agency’s Center for Devices and Radiological Health (CDRH), usually in conjunction with FDA’s Office of Medical Device and Radiological Health Operations, which coordinates device inspections within the Office of Regulatory Affairs (ORA). In addition to these traditional Warning Letters, CDRH issued an additional four Warning Letters related to the marketing and sale of COVID-19 products, such as diagnostic tests, masks, and gloves, without FDA emergency use authorization, clearance, or approval. This is a substantial decrease compared to the COVID-19-related letters issued in 2021, which tallied at a whopping forty-six and which came on the heels of 21 letters issued in 2020 for COVID-19-related marketing. Worth noting, the number of advertising and promotion letters in 2022 appears to remain relatively consistent with recent years, as there were six in 2020 and five in 2021.
All five of the non-COVID-19 Warning Letters issued in 2022 addressed the promotion of unapproved new devices or unapproved new indications of already marketed devices. Notably, three of the five letters were for aesthetic devices; this continues last year’s trend, where aesthetic devices were overrepresented in the device Warning Letters issued by the Agency. Thus, these devices appear to remain high among FDA’s enforcement priorities. In one letter, FDA expressly noted that the letter was preceded by a non-public “It has come to our attention” letter and other private outreaches to the company, thus serving as a reminder that CDRH continues to relay compliance concerns in ways other than Warning Letters. Digital promotion remains an area rife for scrutiny; all of the device letters expressing concerns about device promotion cited promotional activity that occurred, at least in part, on company websites as well as, in one case, non-company websites owned and controlled by a company executive. Additionally, this is also the first time since 2018 where the number of advertising and promotion Warning Letters related to devices outnumbered those related to prescription drugs.
SUMMARY OF ENFORCEMENT LETTERS
For your reference, we have prepared a chart that lists the nine letters issued to pharmaceutical drug and device manufacturers for promotional violations in 2022, including summaries of the promotional violations alleged in each letter and hyperlinks to each letter and related promotional materials. The chart follows this client alert.
WEBINAR: Year in Review for Drug and Device Advertising and Promotion
Join us on January 24 for a review of key takeaways from the FDA’s 2022 drug and device advertising and promotion enforcement letters and a discussion of other noteworthy developments relevant to drug and medical device marketing. Our experienced panel will discuss:
- Lessons learned from 2022 drug and device advertising and promotion enforcement and trends related to social media, patient videos and online interviews, misleading efficacy claims, presentation of risk information, and pre-approval promotion
- Other relevant developments, including recent device-related Lanham Act litigation, FTC activities related to endorsements and consumer reviews, and OPDP research initiatives
- Predictions for what may be expected in 2023
Click here to RSVP.
