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 regarding a promotional social media sponsored post for SLYND® (drospirenone) oral progestin tablets, indicated for use by females of reproductive potential to prevent pregnancy. The post appeared on Facebook, 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.
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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.”
Additionally, FDA noted that the post “overstates the efficacy” of the drug product. FDA’s concern centered around the following claim: “Offer your patients estrogen-free birth control with periods on a schedule”. FDA notes 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.
Furthermore, FDA also noted that Exeltis failed to submit the social media post at the time of publication, as required by FDA regulations. Each submission must include a completed Form FDA-2253 and “a copy of the product’s current professional labeling.” Exeltis failed to submit a copy of the post under an FDA-2253.
The letter follows a trend of OPDP concentrating on the most noticeable violations that present the greatest concerns for public health. The letter is 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. 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.
Finally, this is not the first time that misleading social media promotion by a women’s health-related drugmaker triggered an FDA letter. In 2015, OPDP warned Canadian drugmaker Duchesnay about an Instagram post that influencer Kim Kardashian made in support of morning-sickness pill Diclegis. Because Kardashian’s post had merely linked to Diclegis’ safety information, but failed to mention it, the influencer had to issue a corrective ad that featured the full risk language, even acknowledging that simply including a link fell short of FDA rules.