OPDP Is Still Standing: FDA’s Office of Prescription Drug Promotion Issues Two Enforcement Actions Since Recent Layoffs

Taking a note from Sir Elton John’s 1983 hit, “I’m Still Standing,” the Food and Drug Administration’s Office of Prescription Drug Promotion issued two enforcement actions (one Notice of Violation and one Warning Letter) regarding promotional claims by pharmaceutical companies in under a month, despite recent personnel layoffs. With these two, OPDP has issued three NOVs and one Warning Letter in 2025. OPDP is still standing.

This Bulletin summarizes some of FDA’s major concerns described in the NOV and the Warning Letter. We also offer our observations.

Highlights

Warning Letter

• The Warning Letter discussed a variety of promotional communications: two product webpages, a pamphlet intended for a healthcare provider audience, and an exhibit booth panel at a medical conference.
• Two OPDP representatives reviewed the pamphlet and booth in person at a conference.
• The materials presented comparative claims based on a bioavailability study that was not designed to support such claims, among several other superiority statements that were not supported by data.
• The pamphlet included selective depictions of data, highlighting more favorable information for the company’s product while omitting less favorable information.
• The pieces contained claims that undermined and minimized product risk information and were not properly supported by data.
• OPDP acknowledged that the pieces had included disclaimers, but found that they did not mitigate the misleading impression of the communications.
• The communications omitted material information from the full FDA-approved indication, resulting in an expansion of the indication.
• OPDP noted that it had previously provided advisory comments about concerns regarding the use of comparative claims and presentation of benefits and risks.
• The company failed to submit the materials at the time of initial dissemination or publication (i.e., did not submit a Form FDA 2253).
• OPDP said the promotional violations raised serious public health concerns:

These violations are especially concerning from a public health perspective because the promotional communications misrepresent both the efficacy and risk profile of [product], a product with multiple contraindications and warnings and precautions, that is indicated to treat edema associated with heart failure or renal disease in adults. Both heart failure and renal disease are complex, debilitating medical conditions that disproportionately affect vulnerable populations (e.g., elderly patients) and represent significant public health concerns.

• Typical for a Warning Letter, OPDP requested the company discontinue the communications, correct the information distributed, and identify other pieces with similar messaging.

NOV

• The NOV raised objections to many claims made in a speaker deck, submitted to OPDP by the company on a Form FDA 2253. OPDP read each slide and the associated speaker notes of the presentation noted in the NOV. There are references to different slide numbers to which OPDP cited, and the deck was at least 41 slides from what we can tell.
• The product carried a Boxed Warning and a Limitation of Use.
• OPDP took issue with superiority claims the company made against other combined hormonal contraceptives, implying that its product was safer.
  • It noted the use of terms, such as “unique,” “selective,” “low impact,” and “native,” which it found to misleadingly suggest superiority.
• The speaker deck mischaracterized risk information, particularly relating to product contraindications, providing contradictory narratives and trying to characterize the risk as not being causally related to use of the product.
• Certain comparative claims misleadingly suggested a statistically significant difference that was not supported.
• None of the cited references were found to support the comparative safety and efficacy claims. The materials cited a preclinical study based on in vitro and in vivo animal data, but this did not support the conclusions made in the deck.
• The slide deck contained certain disclaimers, but OPDP found that the disclaimers “do not mitigate the misleading minimization of risks associated with use of [the product].”
• OPDP pointed out that it had previously provided advisory comments addressing certain concerns that it had regarding the presentation of serious risks in the company’s draft promotional communications, but the messaging remained problematic.

AGG Observations

• The NOV and Warning Letter both outlined concerns surrounding comparative claims, minimization of risk, references to data that were not clinically significant to support the claims, and not applying previous advisory comments. We find similar issues in other NOVs and Warning Letters.
• OPDP personnel attend medical conferences. Enough said.
• When OPDP offers advisory comments, seriously consider them.
• Based on the details provided in the Warning Letter, it appears that FDA representatives may have noted issues with the pamphlet and panels at the exhibit booth and then looked at the company’s other promotional materials. While one deficiency may not get OPDP’s attention, a collection of issues can. Once OPDP finds an issue, it is likely to look at other promotional pieces.
• Disclaimers can add certain context and minimize risk, but it cannot eliminate risk if there is an overall misleading impression.

Bringing it back to Sir Elton John, OPDP is still standing, “lookin’ like a true survivor.”