FDA's Office Of Prescription Drug Promotion Issues Second Untitled Letter Of The Year To Exeltis For Misleading Statements Relating To SLYND®

On August 11, 2023, the Office of Prescription Drug Promotion (OPDP) of the U.S. Food and Drug Administration (FDA) issued an untitled letter to Exeltis USA Inc. (Exeltis) regarding a promotional social media sponsored post for SLYND^® (drospirenone) oral progestin tablets, indicated for use by females of reproductive potential to prevent pregnancy (Slynd).¹ The post appeared on Facebook,² and, in addition to being false and misleading, also was not submitted to OPDP at the time of publication as required by FDA regulations. This is only the second untitled letter from OPDP of the year, both of which have focused on false and misleading promotional messaging.

False or Misleading Risk Presentation

FDA concluded that the social media post was misleading with respect to risk because it "fail[ed] to communicate any risk information." FDA noted that in "fail[ing] to provide material information about the consequences that may result from the use of Slynd" the post "creates a misleading impression about the drug's safety." This conclusion is unsurprising, given that failure to communicate any safety balance will result in an FDA letter almost 100% of the time.

False or Misleading Efficacy Presentation

Second, FDA noted that the post "overstates the efficacy" of the drug product. FDA's concern centered around the following claim:

FDA corrected the record, explaining that based on the CLINICAL STUDIES section of the drug's Prescribing Information, "the majority of patients [did] not experience[e] scheduled bleeding (as would be expected during a menstrual cycle)" and a "large proportion of patients still experience[ed] breakthrough bleeding" during treatment with Slynd. Thus, the post was misleading, and thereby misbranded, given that the data did not support the claim that patients would experience "predicable or 'scheduled periods.'"

Failure to Submit Under Form FDA-2253

In addition, FDA also noted that Exeltis failed to submit the social media post at the time of publication, as required by FDA regulations. Pursuant to 21 C.F.R. § 314.81(b)(3)(i), all promotional labeling or advertising must be submitted to OPDP "at the time of initial dissemination of the labeling and at the time of initial publication of the advertisement for a prescription drug product." Each submission must include a completed Form FDA-2253 and "a copy of the product's current professional labeling."³ Exeltis failed to submit a copy of the post under an FDA-2253, and thus was in violation of the requirements of 21 C.F.R. § 314.81(b)(3)(i).

Conclusion

As noted in our July blog post on the first OPDP untitled letter of 2023, this letter follows a trend of OPDP concentrating on low-hanging fruit, singling out the most noticeable violations that present the greatest concerns for public health. Indeed, this letter is fairly straightforward and underscores some foundational principles of drug advertising and promotion: provide a balanced presentation of safety and risks, and ensure that efficacy claims are consistent with clinical trial data. To be sure, one feature that stands out among recent OPDP untitled letters is that this post was not submitted as part of a Form FDA-2253 and was discovered instead as a sponsored post from Facebook's newsfeed. At the very least, this suggests that OPDP is closely monitoring social media drug promotion, and will respond to clear violations of labeling and advertising regulations.

Footnotes

1. Untitled Letter available here: Untitled Letter for Slynd (fda.gov).

2. Promotional Material available here: Promotional Material for Slynd (fda.gov).

3. 21 C.F.R. § 314.81(b)(3)(i).

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.