When was the last time you thought about “data on file” (“DOF”)? Probably not recently, but last week, the U.S. Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) posted an untitled letter (the “Letter”)[1] that was issued on February 3, 2025 to Edenbridge DBA Dexcel (“Dexcel”) over allegedly misleading promotional materials for the multiple myeloma drug Hemady^® (dexamethasone) involving—you guessed it—a DOF reference. This marks OPDP’s first untitled letter of the year and the first under the new administration. The letter is relatively uninventive in terms of enforcement angles—leading with a garden-variety failure to present “any” safety information—but it does serve as a reminder that FDA can and will ask for DOF references, especially those that substantiate Consistent with FDA-Required Labeling (“CFL”) promotional materials. And of course, despite all the news about regulatory cuts affecting FDA, OPDP still appears alive and well.

Promotional Content

FDA took issue with the promotional communication presented in an exhibit booth panel (“panel”)[2] for Hemady^®, a drug indicated in combination with other anti-myeloma products for the treatment of adults with multiple myeloma. Specifically, FDA found the exhibit panel made false or misleading claims about the risks and efficacy of Hemady^®. FDA does not make mention of the intended audience, but given the level of detail in the presentation of information, as well as the piece being part of an exhibit booth, we reasonably conclude the audience was intended to be healthcare professionals (“HCPs”).

Lack of Risk Information

First, FDA found that the panel made no mention at all of any risk information. The panel made beneficial claims such as “Hemady^® reduces up to 80% of the number of tablets required for a therapeutic dose of dexamethasone for the treatment of adults with MM” and “Hemady^® is a unique strength dexamethasone tablet bioequivalent to five 4 mg tablets of dexamethasone.” However, the panel did not present any information about side effects or other risks of the product, which, in FDA’s eyes, created a misleading impression about the product’s safety.

Misleading Claims of Efficacy

Second, FDA found that the panel information was misleading with regard to Hemady’s efficacy. FDA challenged a “Real-World Comparison” of adherence to Hemady^® versus generic dexamethasone among patients with multiple myeloma. Crucially, FDA noted that while DOF was cited as support for the comparison, the associated “Adherence Study” did not support the conclusions regarding comparative adherence to Hemady^® and generic dexamethasone. FDA specifically referenced issues with study design and methodology. Issues included: patients receiving Hemady^® were not verified as having been diagnosed with multiple myeloma in the same way that patients receiving generic dexamethasone were; baseline characteristics were not controlled for across the patient populations; and the generic dexamethasone group had a significantly higher number of patients than the Hemady^® group (3,775 versus 43). In light of these significant study limitations, FDA found the claim of Hemady’s efficacy over dexamethasone to be misleading.

Takeaways

This Letter was relatively short and less scathing than we have seen from FDA in previous untitled letters, but it raises interesting and significant points nonetheless. First, and perhaps most significant to FDA in deciding whether to issue the letter is the matter of risk presentation, or in this case, the complete lack thereof. While it is true that the exhibit panel did not contain any mention of safety information or risks associated with using Hemady^®, it is possible that there were other materials at the exhibit booth that achieved this purpose. We wonder whether the offending piece was submitted on the Form 2253 alone, if it was submitted together with other pieces, or in either case, if the piece referenced other pieces. Alas, FDA makes no mention of other materials outside of the panel, nor does it make clear whether the exhibit booth was reviewed as a whole or if each piece making up the exhibit booth was evaluated for proper risk and efficacy presentation. Readers can draw their own conclusions. In any case, the Letter counsels that each piece of marketing material presented at conferences, symposia, and similar events should be evaluated on its own, as well as in concert with the pieces surrounding it.

CFL forms the basis for the second major issue raised by the Letter, and there are two takeaways resultant. First, FDA can and will scrutinize DOF references. We are no stranger to this and often suggest that clients prepare these references like scientific papers, including design methodologies, results, and conclusions, and having relevant scientific and/or technical experts either within the company or externally vet and sign-off. The level of detail and sophistication of the Adherence Study is unknown because FDA does not opine on it. So, we are left to conclude that regardless of its content, FDA at best wanted more contextual information (and maybe some disclaimers, which FDA loves) about the Adherence Study actually placed on the panel itself, or at worst disagreed entirely with the scientific merit of the Adherence Study and would have found it inappropriate to use, even if “explained/disclaimed-to-death.”

The second takeaway teed-up above is whether FDA would have still objected even in the face of additional contextual information and/or disclaimers. We view the FDA as saying that the study design and methodology do not match the manner in which the conclusions about benefit information are presented, and hence, the result misleads the audience. Without having reviewed the DOF, we will never know whether this is warranted, but it stands to reason that if we assume the exhibit panel contained no falsities in the conclusions presented (FDA never said there were), the DOF may have contained enough context for the HCP to understand that the study did contain various biases, and that the impact of the various factors on adherence should be interpreted with caution.

Readers of the blog will appreciate the extent to which we have discussed CFL in the past and will recall that we believe “context is key.” From a First Amendment protection perspective, the goal in CFL communications (provided you have met all the FDA guidance requirements) should be to provide enough context for the reader to fully understand and interpret the information and to be judicious about making conclusions. [3] The result on this piece may have been different if the CFL box was checked, but FDA already had its “no safety balance” hook, so it is unclear whether this would have made a difference from an enforcement perspective.

As noted at the open, the Letter marks the first major OPDP action under the new administration, suggesting that FDA staffing cuts, de-regulatory efforts, and all that has swirled around this new administration has not stopped OPDP from policing drug promotion. The Letter underscores the persistence of the FDA Bad Ad Program, which was how FDA received a complaint about the exhibit panel.

FOOTNOTES

[1] Untitled Letter available here: Hemady^® Untitled Letter

[2] Promotional Content available here: Hemady^® Promotional Material

[3] Contrary to popular opinion, we do not believe in the “when in doubt, disclaimer” approach. FDA may like disclaimers, but our marketing colleagues do not. So, finding a way to say what we want without hedging the message should be the goal.

Julian Klein contributed to this article.