Haven’t Got Time for the Panel: OPDP Issues Its First Notice of Violation of 2025

This (bad) pun of the 1974 Carly Simon song, “Haven’t Got Time for the Pain,” came to mind when we read the Food and Drug Administration’s Office of Prescription Drug Promotion’s (“OPDP”) first Notice of Violation of 2025.¹ OPDP issued an NOV to a pharmaceutical company for its false or misleading promotion of its prescription drug product. Specifically, the agency took exception to an exhibit booth panel for the product, which is indicated as a treatment in combination with other anti-myeloma products for adults with multiple myeloma, which lacked risk information and supportive data for comparative claims.

This Bulletin summarizes some of the FDA’s major concerns described in the NOV and offers our observations.

Highlights

• FDA learned of the promotion through the company’s Form FDA 2253 submission and a complaint gathered through the FDA Bad Ad Program.
• OPDP emphasized that the product has multiple known serious risks, described in the Prescribing Information section of the approved label.
• The exhibit booth panel presented efficacy claims, but it did not include any risk information for the drug product.
• OPDP also took issue with the panel’s presentation of comparative adherence claims versus the competitor generic product.
  • The company cited “Data on file” to support the presentation, but FDA noted that the referenced study did not support the comparative claims, due to the limitations associated with the study design and methodology, specifically:
    • The patient selection methodology was inconsistent between patients treated with the product versus the generic; the patient selection included distinct patient populations with varying disease severity and stages, and differing treatment regimens.
    • The study protocol did not account for these patient selection characteristics, or whether the product or generic was used as a monotherapy or part of a combination treatment, which could lead to biased adherence calculations.
    • The study had a significantly higher number of patients in the generic drug group (n=3,775) compared to the product group (n=43), and the imbalance between the sample sizes could lead to overestimation of adherence in favor of the smaller sample population.

AGG Observations

• One of the agency’s primary concerns in the NOV is the absence of any risk information in the piece, which will always attract OPDP’s attention.
• OPDP wrote, in a footnote, that it previously requested the study cited as Data on file. We caution clients that “Data on file” or similar internal support can be eye-catching for the wrong reasons; there should be more credible (e.g., peer-reviewed and publicly available) data to support claims.
• We understand the marketing appeal of comparative claims. However, we remind clients that it can be difficult to make such comparisons, because it is hard to tell a complete, non-misleading story in a limited time or space (in this case, an exhibit booth panel).
• While this is the first NOV of 2025, we noted in previous Bulletins that OPDP continues to focus on specific study designs and protocols used to support promotional statements.² Companies should craft promotional messaging carefully, making sure that each claim is supported by statistically sound data. In addition, while not new, OPDP reminds industry that it actually reviews data or articles used to support claims.
• Back to Ms. Simon – make sure that you have got time to provide truthful and complete safety information.

[1] The Notice of Violation is available here: https://www.fda.gov/media/185653/download?attachment.

[2] Please see our previous Bulletins: https://www.agg.com/news-insights/publications/this-time-of-year-opdp-issues-first-letter-in-2024-for-unlawful-promotion/, https://www.agg.com/news-insights/publications/here-we-go-again-fdas-back-in-town-again-opdp-issues-a-second-notice-of-violation-in-less-than-a-month/, and https://www.agg.com/news-insights/publications/rock-you-like-a-migraine-opdp-issues-notice-of-violation-for-misleading-representations-in-tv-ad-that-promoted-popular-migraine-medication/.