The Meals and Drug Administration’s (“FDA”) Workplace of Prescription Drug Promotion (“OPDP”) began 2025 with two Untitled Letters, one in February and one in March, probably signaling extra enforcement for the 12 months. OPDP issued solely 5 enforcement letters in 2023 and 2024, with a heavy concentrate on influencer advertising. Nonetheless, on April 1, 2025, most of OPDP’s employees and management have been a part of the U.S. Division of Well being and Human Companies (“HHS”) Discount in Drive (“RIF”), leaving the business questioning about the way forward for the regulation of prescription drug promoting. Whereas some consider that the RIF won’t considerably affect general enforcement towards prescription drug promoting, the cuts will probably end in even fewer letters in 2025. This can undoubtedly additionally decelerate innovation and probably enable for violative campaigns to be disseminated for longer intervals earlier than OPDP takes motion.
With Commissioner Martin A. Makary having simply been sworn in earlier this month, extra RIFs probably on the horizon and Robert F. Kennedy’s identified stance on direct-to-consumer (DTC) promoting, the business might want to wait and see what occurs with OPDP inside the subsequent few months.
Within the meantime, we offer some highlights under from every of the 2025 Untitled Letters. Whereas these might not characterize the OPDP’s focus going ahead, they do present invaluable steerage for the business in a time of nice uncertainty.
February 3 Letter – False or Deceptive Threat Presentation & Claims about Efficacy
The primary Untitled Letter was issued on February 3, 2025, to a pharmaceutical firm relating to deceptive promotional claims in an exhibit sales space panel for its dexamethasone oral tablets, that are indicated for adults with a number of myeloma (“MM”). The letter cited false or deceptive claims concerning the drug’s advantages and the omission of vital threat data as violating the Federal Meals, Drug, and Beauty Act. The exhibit sales space was submitted to the FDA for overview beneath the quilt of Type FDA 2253. The FDA additionally acquired a criticism concerning the exhibit sales space panel by way of the FDA Unhealthy Advert Program.
A serious concern flagged by OPDP was the exhibit sales space panel’s full omission of threat data. Whereas the panel highlighted efficacy claims, reminiscent of “[DRUG] reduces as much as 80% of the variety of tablets required for a therapeutic dose of dexamethasone for the therapy of adults with MM” and “[DRUG] is a novel power dexamethasone pill bioequivalent to 5 4 mg tablets of dexamethasone”, it failed to incorporate any threat data. Promotional communications misbrand a drug if they’re false or deceptive with respect to threat.
In line with the FDA-approved prescribing data, the drug carries critical dangers, together with however not restricted to endocrine dysfunction, immunosuppression, cardiovascular problems, gastrointestinal perforation, osteoporosis, musculoskeletal points, behavioral and temper disturbances and embryo-fetal toxicity. OPDP decided that by omitting these dangers, the exhibit panel failed to supply materials details about the potential penalties of utilizing the drug, making a deceptive impression concerning the drug’s general security profile.
Along with the claims talked about above, the exhibit panel featured a desk titled “REAL-WORLD COMPARISON OF ADHERENCE to [DRUG] and generic dexamethasone amongst sufferers with MM,” which prompt that the drug had larger affected person adherence charges in comparison with generic dexamethasone. Nonetheless, OPDP recognized important flaws within the cited examine, stating that its design and methodology didn’t help conclusions about comparative adherence between the drug and generic dexamethasone 4 mg within the therapy of MM sufferers.
Moreover, OPDP decided that the protocol didn’t specify whether or not the drug or generic dexamethasone 4 mg was administered as monotherapy or together with different therapies, which has the potential to introduce bias into adherence calculations. OPDP additionally discovered that different components influencing adherence, reminiscent of the overall variety of medicines prescribed, the variety of pharmacies used and affected person age, weren’t managed for within the statistical evaluation, which didn’t alter for these or some other covariates.
One other limitation was the numerous disparity in pattern sizes, with 3,775 sufferers within the generic dexamethasone 4 mg group in comparison with solely 43 within the drug’s group, leading to a considerably unbalanced examine inhabitants. OPDP discovered that this imbalance might contribute to an overestimation of adherence in favor of the affected person group receiving the drug. Moreover, OPDP famous that the examine protocol didn’t deal with the best way to keep away from double-counting sufferers within the dexamethasone group who might have transitioned from NDMM to RRMM.
As a consequence of these flaws, OPDP decided that the examine didn’t present dependable proof to help claims of improved adherence, rendering the promotional claims false and deceptive.
March 21 Letter – False or Deceptive Profit Presentation
The second Untitled Letter was issued to a pharmaceutical firm on March 21, 2025, relating to the promotion of their futibatinib tablets for oral use. The letter addressed considerations over the representations about the advantages of the drug via a webpage titled “Efficacy Outcomes” on the drug’s Healthcare Supplier Branded Web site. This was not the primary time the FDA raised considerations with this pharmaceutical firm’s promotion of the drug. In December 2022, OPDP issued advisory feedback on draft claims and shows for the drug. Regardless of these prior communications, the identical representations have been made within the “Efficacy Outcomes” webpage, probably prompting the Untitled Letter as a consequence of OPDP’s concern that the corporate “seems to be selling [the drug] utilizing comparable claims and shows in a deceptive method.”
OPDP expressed concern that the webpage made false or deceptive claims concerning the drug’s advantages, significantly relating to its efficacy in sufferers with beforehand handled, unresectable, regionally superior or metastatic intrahepatic cholangiocarcinoma (“iCCA”) harboring fibroblast progress issue receptor 2 gene fusions or different rearrangements. Particularly, the webpage included Kaplan-Meier survival graphs displaying progression-free survival (“PFS”) and general survival (“OS”) knowledge from the FOENIX-CCA2 trial. The OPDP highlighted that the FOENIX-CCA2 examine was a single-arm trial, which means there was no comparator group. As such, the outcomes from this examine couldn’t be used to definitively present whether or not the drug’s results on PFS and OS have been attributable to the drug or to different components, such because the pure development of the illness. And not using a comparator, these time-to-event efficacy endpoints are deemed uninterpretable. Whereas the webpage did embrace some disclaimers, reminiscent of warnings that the info ought to be interpreted with warning, OPDP deemed these inadequate to appropriate the deceptive implications.
One other concern raised by OPDP was the presentation of the drug’s illness management price (“DCR”). The webpage offered an 83% DCR primarily based on a composite of full response (“CR”), partial response (“PR”) and secure illness (“SD”), and likewise included comparable outcomes from an prolonged follow-up evaluation. OPDP discovered that these shows made these promotional communications deceptive by suggesting that the drug improves DCR in sufferers with regionally superior or metastatic iCCA primarily based on a composite of CR, PR and SD when the examine from which the shows have been drawn couldn’t show this end result. Furthermore, since FOENIX-CCA2 was a single-arm examine, the examine didn’t set up that the SD end result was attributable to the impact of the drug. Subsequently, the DCR knowledge offered on the webpage couldn’t be thought of as proof of the drug’s efficacy.
Sensible Takeaways
- Firms ought to be sure that all promotional supplies include a transparent, outstanding and simply comprehensible presentation of dangers.
- All efficacy and comparative claims ought to be supported by well-designed, peer-reviewed research. When citing real-world knowledge, corporations ought to use constant affected person choice standards, management for illness severity, therapy variations and confounding components, and keep away from pattern dimension imbalances that might skew outcomes.
- An entire lack of threat data won’t solely entice OPDP’s consideration, but in addition that of a well being care supplier who might determine to report the promoting to the FDA as probably false or deceptive via the FDA’s Unhealthy Advert program.
- If an organization requests advisory feedback from OPDP on sure promotional supplies, it ought to guarantee to implement these feedback in any future promotions. Failure to include OPDP’s feedback when utilizing comparable claims will catch the FDA’s consideration and most frequently end in an enforcement motion.
- These letters stands out as the solely letters we see from OPDP for some time given the numerous employees discount. Firms must keep tuned to see what, if something, occurs with DTC promoting this 12 months.
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