Exeltis, a pharmaceutical company, has come under sharp criticism from the FDA for a sponsored social media post promoting its birth control pill, Slynd. The FDA’s untitled letter accuses Exeltis of multiple violations, including neglecting to provide risk information, presenting misleading efficacy claims, and failing to submit the material for review before its initial publication.
A pivotal point of contention revolves around Exeltis’s failure to comply with FDA regulations. The agency mandates that drug product advertisements must be submitted for review upon publication. The FDA contends that Exeltis publicly released the post without adhering to this crucial requirement, leading to a violation of regulatory protocols.
Upon scrutinizing the content of the social media post, the FDA detected glaring omissions. Notably, the post conspicuously omitted any mention of the potential risks associated with Slynd, despite the drug’s label clearly detailing warnings and precautions encompassing elevated potassium levels, blood clot risks, bone density reduction, cervical cancer concerns, and more. The absence of risk information renders the post misleading and fails to provide essential insights into the potential consequences linked to Slynd’s usage.
The FDA also took issue with the specific content Exeltis included in the post. The agency’s Office of Prescription Drug Promotion singled out the claim “offer your patients estrogen-free birth control with periods on a schedule” as deceptive. The FDA interpreted this assertion as implying that individuals using Slynd can anticipate predictable menstrual periods. However, the FDA asserts that this assertion “overstates” Slynd’s efficacy.
Citing clinical data from Slynd’s product information, the FDA contested the claim by highlighting that in a clinical trial, the proportion of patients experiencing scheduled bleeding diminished significantly from 81.2% to 26.4% after 13 treatment cycles. Furthermore, the data indicated a connection between Slynd and instances of unscheduled bleeding and spotting.
In the untitled letter dated August 11, the FDA admonished Exeltis for its violations of the Federal Food, Drug, and Cosmetic Act. The company was granted 15 working days from the letter’s receipt to respond and address the FDA’s concerns. The agency has requested Exeltis to outline measures to rectify the issues, enumerate other promotional materials featuring similar messages, and provide a plan to discontinue such misleading communications.
The regulatory intervention highlights the importance of accurate and transparent drug promotion, underscoring the FDA’s commitment to ensuring that patients receive truthful information about potential risks and benefits associated with medication.
