Summer may be ending, but enforcement from the Food and Drug Administration’s (“FDA”) Office of Prescription Drug Promotion (“OPDP”) is just heating up. After months of silence (see here for our discussion of OPDP’s first enforcement letter of 2024 five months ago), OPDP issued back-to-back Untitled Letters in July and August bringing the total for 2024 to three Untitled Letters. Interestingly enough, no warning letters have been issued this year. So, does this mean we will end the year with more than five enforcement letters from OPDP? As you may recall, OPDP issued five letters in 2023 (four Untitled Letters and one Warning Letter). With four months left in the year, “only time will tell.” Below we provide some highlights from each of the Untitled Letters.
July Letter – False or Misleading Risk Presentation
The first Untitled Letter was issued on July 17, 2024, against a pharmaceutical company for a promotional communication, in the form of an Instagram post, for the company’s epinephrine injection, which was submitted to the FDA under cover of Form FDA 2253. Brittany Mahomes, an American sports team owner, retired soccer player and social media influencer (and of course, wife to Kansas City Chiefs quarterback, Patrick Mahomes), posted a video on her personal Instagram account in “[p]aid partnership with [the drug company].” The drug, which is indicated for the emergency treatment of allergic reactions, including, but not limited to, anaphylaxis to stinging and biting insects, foods, drugs and other allergens, also has several warnings and precautions “regarding emergency treatment, injection-related complications, serious infections at the injection site, allergic reactions associated with sulfite and disease interactions.” Other common reactions to systemically administered epinephrine, include “anxiety, apprehensiveness, restlessness, tremor, weakness, dizziness, sweating, palpitations, pallor, nausea and vomiting, headache, and respiratory difficulties.” That said, OPDP found Mrs. Mahomes’ post to be false or misleading in that it presented information about the benefits of the drug but failed to include any of the drug’s risks.
OPDP highlighted three concerning claims from the Instagram post which included a video and text:
- “So, I have an infant and a toddler both who have severe food allergies . . . Based on my experience, I can tell you that a severe reaction may not look how you think it should look. So, after the diagnosis, a big part of the plan was going to my pediatrician, and he did prescribe me [the drug]. [The drug] is the only epinephrine autoinjector out there for infants and toddlers.” (AVO, video portion of post)
- “[The drug] (epinephrine injection, USP) is for life-threatening allergic emergencies.” (SUPER, video portion of post)
- “[S]haring my experience with [my child’s] severe allergic reaction to peanuts . . .. partnering with @ [the drug’s social media account] to help spread awareness about severe food allergies in young children and how to best respond . . . [the drug] 0.1 mg is for infants and toddlers 16.5-33 lbs.” (text portion of post)
OPDP concluded that Mrs. Mahomes’ post was misleading as it presented efficacy claims for the drug but entirely omitted all risk information, including warnings and precautions regarding emergency treatment, injection-related complications, serious infections at the injection site, allergic reactions associated with sulfite and disease interactions. OPDP also found that Mrs. Mahomes did not include the list of the common adverse reactions to systematically administered epinephrine. OPDP acknowledged that although Mrs. Mahomes’ post included the statement, “For Important Safety Information, visit @[the drug’s social media account][.],” the disclaimer did not mitigate the “misleading impression created by the omission of risk information.” As such, OPDP found “[b]y omitting the risks [with the drug], the post failed to provide “material information about the consequences that may result from the use of [the drug]” and created a misleading impression about the drug’s safety.
August Letter – False or Misleading Benefit Presentation
The second Untitled Letter was issued to a biotech company on August 1, 2024, for claims on a branded website, intended for health care professionals, for its non-small cell lung cancer drug. The oral tablet was approved for use under the FDA’s accelerated approval pathway which allows for quicker approval of drugs “intended to treat serious conditions and fill an unmet medical need…based on an effect on a surrogate or intermediate clinical endpoint that is thought to be reasonably likely to predict clinical benefit, rather than on a direct measurement of clinical benefit.” According to OPDP, the company’s website made a plethora of false or misleading claims and representations about the benefits of the drug. It is also important to note that OPDP received several complaints about the website through the Bad Ad Program.
OPDP highlighted several issues with efficacy claims presented on the website related to “depth of response,” “disease control rate” and rates of “stable disease,” “partial response,” “complete response” and “progressive disease” from the company’s study used to gain accelerated approval. The FDA requires those who sponsor drugs approved under the accelerated pathway to conduct a confirmatory trial to verify and describe the clinical benefit of the drug. OPDP explained that the study of the drug’s effect on objective response rate and duration of response failed to establish that the stable disease observed was a result of the drug’s efficacy, as that type of determination would have to be based on the results of a randomized trial. OPDP also highlighted similar concerns with the website’s presentation of disease control rate, progression-free survival and overall survival results as the study’s design was not structured to produce reliable results on those specific data points.
Moreover, OPDP found issues with claims related to the duration of response data. Specifically, OPDP explained that they were not able to confirm the results of the data and were “not aware of data that support[ed] [the] claim that the median [duration of response] for patients treated with [the drug] is 12.5 months.” The company had cited “data on file” for the claim and described the data as “pooled DOR” in its submission to the FDA. However, OPDP noted that “[p]ooling data poses analytical problems as differences among studies and study populations can affect the validity and interpretability of such pooled analyses.” Based on the information provided, OPDP was not able to verify the results. Additionally, OPDP was not aware of any data that would support the duration of response claims. As such, OPDP requested that the company submit any data it had to support the claim for review.
Lastly, OPDP found that the claims based on a post-hoc analysis were misleading and that a disclaimer outlining the limitations of the post-hoc analysis were “not sufficient to mitigate the overall misleading impression created by the inclusion of this presentation.”
Practical Takeaways
- OPDP continues to take social media and internet advertisement seriously and has remained consistent with its expectations for companies within the pharmaceutical space. As such, it is important to remain diligent when making all efficacy claims related to a product to ensure that the post is properly balanced with risk information.
- While a post can include a link for consumers to review some additional safety information, the post cannot only include benefits and require the consumer to click on a link to learn about the risks associated with the product.
- When determining whether to partner with social media influencers, companies should remember that all social media posts in partnership with a manufacturer are considered part of the promotional communication for a drug and will be scrutinized accordingly.
- Products marketed for use in children will always carry a higher level of scrutiny by OPDP/FDA.
- Companies should carefully evaluate what conclusions can be made from their studies and ensure that the studies can in fact support those conclusions. Post-hoc analysis can be particularly problematic as the results are usually of limited applicability and a disclaimer explaining those limitations may not be sufficient to avoid and/or minimize any misleading impressions created by the presentation of the data.
- Companies need to keep the Bad Ad Program in mind when disseminating information and remember that health care providers can submit to the FDA any promotion that they perceive to be unlawful.
- As with social media, the addition of a disclaimer may not be sufficient to mitigate risk.
For more information on the advertising and promotion of drugs, biologics or medical devices, please contact:
- Carolina Wirth at (202) 780-2989 or cwirth@hallrender.com;
- Jemalyn Harvey at (202) 780-2990 or jharvey@hallrender.com; or
- Your primary Hall Render contact.
Special thanks to Tarra Olfat, Summer Associate, for her assistance with the preparation of this article.
Hall Render blog posts and articles are intended for informational purposes only. For ethical reasons, Hall Render attorneys cannot—outside of an attorney-client relationship—answer specific questions that would be legal advice.
