Regardless of latest reductions-in-force (“RIFs”) on the Meals and Drug Administration (“FDA” or “Company”), the Company’s Workplace of Prescription Drug Promotion (“OPDP”) has signaled that enforcement stays a precedence. On April 28, 2025, OPDP issued its third Untitled Letter of the 12 months — notably, the primary following the April 1 RIFs, which impacted OPDP staffing. As of now, OPDP seems to be on tempo to exceed the variety of Untitled Letters issued in 2024. Final 12 months, OPDP issued 5 Untitled Letters in complete, with 4 of these launched through the latter half of the 12 months (July by means of October).
OPDP issued this Untitled Letter in reference to an organization’s submission of a promotional speaker deck and accompanying speaker notes for an oral contraceptive drug, submitted pursuant to Kind FDA 2253. In response to FDA, the speaker deck made “false or deceptive claims in regards to the dangers” of the drug, which have been significantly regarding on condition that the drug product is “related to a lot of critical and probably life-threatening dangers, together with a boxed warning concerning elevated threat of great cardiovascular occasions from cigarette smoking and [combined hormonal contraceptives use (“CHC”)].”
The drug product was permitted by FDA in 2021, and OPDP offered the corporate with advisory feedback in January 2022 on draft promotional communications. Thus, FDA expressed concern that the corporate was “selling [the drug] with out presenting the intense dangers of the drug in a truthful and non-misleading method, regardless of OPDP’s prior feedback.”
False and Deceptive Claims and Displays about Danger
A central concern cited within the Untitled Letter concerned deceptive claims with respect to the presentation of threat. Particularly, the speaker deck included claims that advised that the drug product, due to its energetic estrogen ingredient, estetrol, was safer than different types of CHC, together with people who contained ethinyl estradiol, a declare that has not been substantiated.
Particularly, the speaker deck included, amongst different issues, “quite a few claims and shows evaluating the pharmacologic properties and purported advantages of estetrol (e.g., “claims of ‘low-impact,’ and ‘minimal impact on the liver’”) to these of different estrogens.” In response to OPDP, these claims “misleadingly” advised that the drug product was “distinctive” and “intrinsically completely different” from different estrogens, thus making it a “safer type of estrogen-containing oral contraception as a result of its ‘low-impact’” properties.
OPDP additionally took concern with claims, with related p-values, suggesting that the drug demonstrated a statistically important distinction in a number of noticed endocrine and hemostatic parameters as in contrast with the 2 reference CHCs. Nonetheless, that suggestion was not supported by the research submitted to the Company. The protection examine didn’t prespecify the thresholds for clinically related variations in results of the examine merchandise on the varied endocrine and hemostatic parameters. In consequence, the info was thought of “descriptive” and never supportive of the conclusions offered. Whereas the corporate included a disclaimer that “[n]o scientific variations needs to be constructed from the outcomes proven…straight previous these claims and shows…,” the assertion didn’t “mitigate the deceptive impression.”
The slide deck additional minimized critical identified dangers related to the usage of the drug product, together with the potential for thromboembolic occasions, liver-related points, glucose intolerance and hypertriglyceridemia. These dangers have been well-documented within the product’s Prescribing Info (“PI”). For instance, the speaker deck included claims concerning the drug’s minimal influence on liver parameters and clotting elements; nonetheless, the drug is contraindicated in people with hepatic illness and is related to elevated dangers of vascular problems.
Furthermore, the slide deck included claims that advised that the drug could also be appropriate for people with or in danger for breast most cancers. Particularly, OPDP took concern with claims that estetrol has a “low influence on breast tissue…and doesn’t stimulate breast tissue.” These claims weren’t substantiated by human scientific knowledge and will mislead well being care suppliers (“HCPs”) into considering that the drug is a safer choice for sufferers who had or have had breast most cancers, when the truth is, the drug is contraindicated in people with a present prognosis or historical past of breast most cancers which can be delicate to sure hormones.
Lastly, the slide deck additionally omitted materials details concerning the dangers of hyperkalemia, migraines with aura and menstrual bleeding irregularities related to the drug product. Whereas the speaker deck included a press release directing HCPs to seek the advice of the total PI and included a hyperlink to the PI all through the speaker deck, OPDP once more emphasised that these statements didn’t mitigate the “deceptive minimization of dangers” related to the usage of the product.
Sensible Takeaways
- Even when years have handed, failing to mirror OPDP’s prior suggestions might counsel that the corporate disregarded earlier regulatory issues.
- Minimizing or omitting critical dangers (e.g., boxed warnings, contraindications), particularly for medicine with a boxed warning, undermines truthful and non-misleading promotion and can result in an enforcement motion from OPDP.
- Disclaimers and hyperlinks to the PI, whereas they are often useful, don’t mitigate the influence of deceptive claims or omitted dangers.
- Guarantee all promotional content material is totally vetted by Medical, Authorized and Regulatory (“MLR”) reviewers, with clear documentation of supporting knowledge and supposed claims. MLR groups stay key in making certain that promotional supplies are balanced and that there’s substantiation for all claims utilized in promotion.
- To this point, OPDP is on tempo to surpass the variety of letters issued in 2024. With the potential for elevated consideration on direct-to-consumer promoting, will probably be necessary to look at whether or not this turns into a major focus for OPDP within the the rest of 2025.
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