It is hard to believe that spring is finally here and the Food and Drug Administration’s (“FDA”) Office of Prescription Drug Promotion (“OPDP”) has yet to take any enforcement action in 2023. While this seems unusual, it appears consistent with the OPDP’s seemingly measured approach to enforcement actions in recent years. It may also be the result of a decrease in the quantity of marketing materials being submitted to the OPDP for review.
In 2022, the OPDP issued a total of four letters – three Untitled Letters and one Warning Letter – to pharmaceutical companies marketing prescription drug products and biologics. Untitled Letters identify issues that should be corrected but would not result in an official citation by the FDA and are used by the FDA as initial notification to a company of a violation. Untitled Letters allow a company to correct the violations without any further FDA action. Warning Letters are often issued to companies for significant regulatory violations that can result in enforcement actions unless the company promptly corrects the problems noted by the FDA. Similarly, OPDP only issued six letters in 2021 (four Untitled and two Warning letters). Thus, the number of enforcement actions continues to decrease, despite the FDA’s return to “normal” operations following the COVID-19 pandemic. On the other hand, OPDP’s remains heavily reliant on Untitled Letters as a way to achieve compliance in this space.
The following summary provides some key takeaways and lessons learned from the 2022 letters that can serve as informative guideposts for 2023.
Practical Takeaways
Letters. The three Untitled Letters involved promotional materials that were submitted to the FDA in the ordinary course of business using Form FDA 2253. Additionally, one of the letters involved promotional materials also submitted to the FDA’s Bad Ad Program. The Bad Ad Program is an outreach program run by the OPDP designed “to help health care providers (“HCPs”) recognize potentially false or misleading drug promotion.” More information about the Bad Ad Program is available at The Bad Ad Program | FDA.
Thus, we recommend that:
- Companies be aware that even if materials are reviewed by their promotional review committee process, the FDA may still disagree with the company’s determination that the material submitted is truthful, balanced and not misleading.
- When preparing promotional materials, Companies should consider the Bad Ad Program and the possibility that their materials could be submitted to the FDA by anyone, including HCPs.
The single Warning Letter issued by the FDA was issued following the OPDP’s review of a video posted on the Company’s corporate website. While it is unusual for the OPDP to issue a letter for pre-approval promotion, particularly a Warning Letter, it appears that the OPDP concluded that the Company’s actions required such a response given that the product was being promoted as a treatment for COVID-19. Therefore, when posting videos and other information to their corporate sites, we suggest that:
- Companies ensure that the information is truthful, balanced and not misleading and not considered a pre-approval promotion. While a corporate site can quickly be updated, if needed, companies should still consider having all materials reviewed by their promotional review committee, including any materials posted and/or developed by the company’s senior leadership, before posting them.
Direct-to-Consumer Drug Promotion. Two letters involved direct-to-consumer (“DTC”) videos, indicating the OPDP’s continued monitoring and scrutiny of advertisements directed at consumers who the FDA considers to be more vulnerable than HCPs. Consequently, when preparing and reviewing DTC materials, we recommend considering the following:
- Failure to include risk information or the minimization of risk information are two areas of great importance to the OPDP.
- Risk information should be presented in a prominent conspicuous manner and not be buried at the bottom of the post. Companies should not rely on a third-party platform (e.g., Instagram) to ensure that the segment or video is truthful, balanced and not misleading to consumers.
- When preparing DTC information, evaluation of the following factors should inform the presentation of risk and benefit information: typography, layout, contrast, headlines, white space and other techniques apt to achieve emphasis.
Use of Clinical Data. The OPDP continues to scrutinize the use of study data in promotions. For example, one letter noted that a company combined the results of two separate and unrelated studies to support certain efficacy claims. The studies differed in several ways, including differences in patient population, type and dose of the product, and duration of the study. Another company attempted to support some efficacy claims by using data derived from a post hoc analysis of phase 2 clinical trial data. Because the analysis had been conducted post hoc, there were no controls for false positive rates and, thus, no way to determine whether results could be attributed to the drug or merely due to chance. Accordingly, the OPDP concluded that any claims and presentations that drew conclusions from those results were misleading. The company did include a statement on the website that said, “Post hoc analysis of a phase 2 clinical trial”; however, the OPDP noted that this did not mitigate the misleading impression created by the claims.
Thus, when using clinical data to support claims, the following considerations are important:
- Companies should review study data and determine what claims they can make rather than develop a claim and then back into how to tailor existing data to support that claim.
- Disclaimers and qualifiers may help minimize risk when and if used appropriately; however, they do not eliminate risk.
Conclusion
While 2023 is off to a relatively quiet start, we expect the OPDP to continue to focus on social media and internet promotion, DTC campaigns and marketing campaigns involving high-risk drugs and biological products. A Company’s promotional review process continues to be the key to minimizing the chances of receiving an Untitled or Warning Letter from the FDA, especially when it comes to the marketing of high-risk products and DTC campaigns. Proactive development of a system that ensures compliance with the OPDP’s promotional requirements can also be an effective tool to diminish other risks such as whistleblower complaints or enforcement actions by the Department of Justice or the Office of Inspector General.
If you have questions about the OPDP’s requirements and guidelines for promoting prescription drugs and biological products, please contact:
- Carolina M. Wirth at (202) 780-2989 or cwirth@hallrender.com;
- Melissa L. Markey at (248) 310-4876 or mmarkey@hallrender.com; or
- Your Hall Render attorney.
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.
