FDA and FTC Guidance Documents Target Direct-to-Consumer Medical Product Promotion
Two new FDA and FTC guidance documents are the latest reminder that Direct-to-Consumer (DTC) medical product promotion continues to be a focus of regulatory attention:
- FDA published its final guidance on “Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DTC) Promotional Labeling and Advertisements” (DTC Quantitative Information Guidance) on June 28, 2023. FDA’s recommendations focus on how to convey essential quantitative information as well as formatting and visual considerations.
- FTC finalized its revisions to its “Guides Concerning the Use of Endorsements and Testimonials in Advertising” (Endorsement Guides) on June 29, 2023.1 The revised guides address changes in the ways advertisers reach consumers to promote products and services via patients, healthcare professionals and celebrities, including through social media, and it emphasizes eight key enforcement principles.
These guidance documents, along with other regulatory initiatives by both agencies,2 ongoing research by FDA into consumer safety information comprehension,3 and targeted administrative enforcement actions, appear to signal an increase in scrutiny over DTC medical product promotion, especially in the social media space.
FDA Refines Expectations for DTC Prescription Drug and Biologic Promotion
The final DTC Quantitative Information Guidance, drafted by FDA’s Office of Prescription Drug Promotion (FDA-OPDP) in conjunction with FDA’s Center for Biologics Evaluation and Research and the Center for Veterinary Medicine, makes recommendations for how firms should present the likelihood or magnitude of a drug’s efficacy or risks in branded DTC promotional communications. While the FDA DTC Quantitative Information Guidance is non-binding, it represents one of the most sophisticated statements of FDA-OPDP’s views on the issue of DTC promotion to date. Key recommendations focus on the conveyance of essential information and formatting and visual considerations, and include:
- Provide quantitative information from both the treatment group and the relevant control group when conveying safety or benefit information.
- Present quantitative efficacy or risk probabilities in terms of absolute frequencies (e.g., “1 out of 10 patients”) or percentages (e.g., “10% of patients”), as opposed to in terms of relative frequencies (e.g., “50% reduction in symptoms”).
- Ensure that appropriate consumer-friendly contextual information is conveyed when relative frequency information is conveyed.
- Present quantitative efficacy or risk information in the same numerical format throughout a promotional communication and using the same denominator when presenting absolute frequencies.
- Select visual aid designs that accurately communicate quantitative risk or efficacy information, and do not unduly minimize limitations or safety information.
- Consider the amount of space or time and any other factors of the specific promotional media type (e.g., print, electronic, audiovisual, etc.) when presenting quantitative information.
While FDA-OPDP has identified some of these elements in other guidance documents or in Untitled and Warning Letters, the DTC Quantitative Information Guidance provides clear, practical examples and builds on the results of FDA’s consumer comprehension research. In one of the eight examples provided, FDA-OPDP illustrates its expectations on how to present gradations of symptom relief in a manner consistent with the above recommendations:
In a clinical trial for Drug X, 54% of patients treated with Drug X experienced moderate symptom relief and 19% of patients treated with Drug X experienced complete symptom relief, compared to 28% of patients treated with placebo and 2% of patients treated with placebo, respectively.
The firm is developing a patient booklet for Drug X that contains the following information: In the clinical trial, the majority of patients experienced moderate symptom relief after treatment with Drug X, and 19% of patients experienced complete symptom relief. In patients treated with placebo, less than half of the patients experienced moderate symptom relief and 2% of patients experienced complete symptom relief.To present the information consistently, the firm should include the "majority of patients (54%) and "less than half of patients (28%)" in the proposed patient booklet. Alternatively, the firm could consistently present only the quantitative information throughout the piece (e.g., "...54% of patients treated with Drug X experienced moderate symptom relief...," "...28% of patients treated with Drug X experienced moderate symptom relief...," "...28% of patients treated with placebo experienced moderate symptom relief..."). 4
The attention to material disclosure or omission issues is unsurprising, given FDA-OPDP’s general shift away from “off-label” promotion enforcement efforts following the decision in Amarin Pharma, Inc. v. FDA,5 and FDA-OPDP’s focus on contextual disclosures when assessing whether clinical data used in the promotional context is considered to be “consistent with” a product’s approved labeling for purposes of FDA enforcement discretion.6 For example, in a June 7, 2023 Untitled Letter, FDA-OPDP took issue with qualitative and quantitative safety and efficacy claims on the recipient’s consumer-facing website.7 FDA-OPDP alleged, among other things, that the recipient misrepresented efficacy results from the drug’s pivotal studies by not disclosing information that FDA indicated was necessary for consumers to be able to fully understand the advertised study results, including that at least half of the subjects in one of the studies discontinued treatment prematurely due to adverse reaction, lack of efficacy, or other reasons. Last year, FDA alleged that an Instagram advertisement was false and misleading because it overstated product benefits and understated risk information.8 In particular, FDA noted that the advertisement failed to adequately communicate the drug’s FDA-approved indication and the limitations of use, and that fast-paced visual elements, busy scenes, and a strong fast-moving musical beat allegedly distracted consumers from important safety information relegated to a small window at the end of the advertisement.
Readers should track forthcoming9 FDA DTC guidance, which continues to build on the themes discussed above. As FDA continues to conduct and publish studies — including four recently completed experimental studies on character-space-limited online prescription drug communications (published in December 2022)10 and studies on DTC Advertising Directed at Adolescents and Oncology Indications in Direct-to-Consumer Television Advertising (pending peer review and publication) — we expect more developments and an increase in the scrutiny over relevant industry communications.
FTC Increases Scrutiny of Endorsements and Health Product Claims
FTC continues to be the dominant regulator in the area of consumer endorsements, and in FTC’s June 29 updates to the Endorsement Guides the agency has focused its attention on the life sciences sector. As covered in our past Advisory, FTC’s proposed revisions to the Endorsement Guides in May 2022 proposed amendments to all six sections and reflect heightened scrutiny of endorsements and digital advertising via social media platforms. The new updates to the final Endorsement Guides focus on addressing changes in the ways advertisers reach consumers to promote products and services (the Endorsement Guides had been last revised by FTC in 2009), including promoting products through social media and reviews — a growth area for prescription drug and device company promotion. The revised Enforcement Guides emphasize eight key enforcement principles:
- For compliance purposes, the terms “Endorsement” and “Endorser” are construed broadly.
- Disclose material connections, with consideration of the “significant minority” who may not know the connection exists.
- Remember, endorsers and intermediaries can be held liable too.
- Understand that expert endorsers are subject to higher standards and must have the expertise they are represented as having in an advertisement.
- Use caution when pairing consumer endorsements with images that are not of the consumer.
- Always disclose typical results.
- Avoid consumer review practices that the FTC has identified as misleading (such as modifying consumer reviews in a way that distorts or misrepresents the consumer’s opinion of the product).
- Take into account the target audience.
The Endorsement Guides now include several new or updated examples of health-related endorsements that specifically mention categories of FDA-regulated products, including hearing aids, acne treatments, and cholesterol-lowering drugs. FTC has also reemphasized its jurisdiction over all medical products (even when secondary to FDA) through issuance of FTC’s “Health Products Compliance Guidance,” which covers all health-related claims for a broad range of products, including conventional foods, dietary supplements, drugs, and medical devices,11 and through subsequent issuance of a notice of penalty offenses to over 670 companies, reminding industry of the agency’s claim substantiation expectations for all health-benefit and safety claims.12 Penalty notices have been historically followed by FTC enforcement, and thus FTC’s recent activities signal that FTC is prepared to exercise broad jurisdiction over health-product advertising and that the agency may increase enforcement related to health-related claims for medical products, the use of endorsements through social media, and the use of fake or misleading consumer reviews.13
For more in-depth coverage of FTC’s finalized revisions of the Endorsement Guides, we recommend reviewing our Advisory, “FTC Signals Continued Heightened Scrutiny of Endorsements With Final Rule Adopting Revised Endorsement Guides.
These developments show that FDA-OPDP is looking more closely at how drug companies promote their products to consumers using quantitative information labeling and advertising. FTC is signaling that it is prioritizing review of endorsements, construed broadly, and that drug and device company endorsements are not immune from FTC scrutiny. While regulatory agencies are eager to regulate DTC promotion — particularly social media-based promotion, which has increased substantially year-over-year — we note that this trend exists against a backdrop of judicial skepticism about the extent to which the government should be able to police social media and commercial speech.14 While FDA has not completely retreated from policing the use of endorsements in conventional product labeling and advertising (famously taking action in 2015 against a company for social media posts authored by Kim Kardashian), it has been reluctant to finalize clear policies governing social media.15 For now, FTC’s Endorsement Guides appear to fill a void and indicate that FTC is willing to play a larger role in policing the medical products industry than it perhaps has before. The investment by these agencies in studies and guidance suggests that expanded enforcement against consumer-direct communications deemed misleading or deceptive, particularly where there is a risk of consumer harm, is highly likely.
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© Arnold & Porter Kaye Scholer LLP 2023 All Rights Reserved. This blog post is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.
The Endorsement Guides ar codified at 16 CFR Part 255. At the time of the publication of this Advisory, FTC’s finalized revisions do not yet appear in the Guides Concerning the Use of Endorsements and Testimonials in Advertising as codified at 16 CFR Part 255, nor has the applicable final rule been published yet in the Federal Register.
Two other recent initiatives worth watching in the DTC marketing space are FDA’s recent proposed rule regarding communication of core product information in patient medication guides (Federal Register announcement available here) and FTC’s recent proposed rule on use of consumer reviews and testimonials (proposed Federal Register notice available here).
See, e.g., H. Sullivan et al., “Communicating Benefit and Risk Information in Direct-to-Consumer Print Advertisements: A Randomized Study,” Ther. Innov. Regul. Sci. 2015 Jul;49(4):493-502; H. Sullivan et al., “Presenting Quantitative Information About Placebo Rates to Patients,” JAMA Intern Med. 2013;173(21):2006-2007; and A. O’Donoghue et al., “Randomized study of placebo and framing information in direct-to-consumer print advertisements for prescription drugs,” Ann. Behav. Med. 2014 Dec;48(3):311-22.
FDA Guidance for Industry, “Medical Product Communications That Are Consistent With the FDA-Required Labeling, Questions and Answers” (June 2018).
FDA Untitled Letter to Xeris Pharmaceuticals, re: Recorlev® (levoketoconazole) tablets, issued June 7, 2023.
FDA Untitled Letter to Xeris Pharmaceuticals, re: Recorlev® (levoketoconazole) tablets, issued June 7, 2023.
FDA untitled Letter to Eli Lilly and Company, re: Trulicity® (dulaglutide) injection, issued January 19, 2022.
For example, the FDA’s Spring 2023 regulatory agenda states that the agency plans to publish a final rule soon on “Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, Neutral Manner in Advertisements in Television and Radio Format.”
FTC, Health Products Compliance Guidance (December 2022), available here.
Following the release of the updated Health Products Compliance Guidance, in April 2023 FTC sent a notice to nearly 700 companies, including several companies that market drugs or medical devices, regarding the agency’s claim substantiation expectations. The notice alerted companies engaged in the marketing or sale of health-related products that they could incur significant civil penalties (up to $50,120 per violation) if they fail to adequately substantiate their health and safety claims for such products.
FTC has also prioritized combatting fake or misleading consumer reviews, including by proposing a new rule on the use of consumer reviews and testimonials. For more information about the new rule, “The Trade Regulation Rule on the Use of Consumer Reviews and Testimonials,” please see our Advisory, FTC Proposes New Rule to Prohibit Fake Reviews.
For example, as of the time of publication of this Advisory, a Louisiana federal judge has issued a preliminary injunction barring numerous federal agencies from taking actions to monitor and police social media channel content. See State of Missouri v. Joseph Biden et al., 3:22-CV-01213 (W.D. La. Jul. 4, 2023). Courts in other cases have similarly raised questions about the bounds of agency authority to regulate social media and speech, and Congress and the public have also raised concerns in this space.
In particular, FDA has conducted research on endorsements in the specific context of medical products, with two ongoing studies on “Endorser Status and Explicitness of Payment in Direct-to-Consumer Promotion” to evaluate how consumers respond to varying types of endorsers and payment disclosures in relation to the promotion of a health products in print and social media. The research is examining four types of endorsers (celebrity, physician, patient, and influencer) and direct and indirect disclosures to see how disclosure of the endorser’s payment status influences the subjects’ recall, benefit and risk perceptions, and behavioral intentions. While FTC has taken the lead in policing endorsement disclosures to date, OPDP’s studies are expected to impact FDA’s expectations in this space.