Facebook post prompts untitled letter to birth control maker Exeltis

The US Food and Drug Administration (FDA) recently sent Exeltis USA an untitled letter citing the company for a Facebook post promoting its birth control pill Slynd (drospirenone) without fully disclosing its risks and making a false or misleading claim about the drug’s efficacy. According to the agency, the company also failed to file the proper paperwork after making the post.

FDA sent an untitled letter to New Jersey-based Exeltis USA on 11 August, where it reprimanded the drugmaker for failing to meet regulatory requirements when promoting Slynd. The agency argued that the company’s post, viewed on 5 August 2023, failed to disclose “any risk information” about the drug.

“The determination of whether a promotional communication is misleading includes, among other things, not only representations made or suggested in the promotional communication but also the extent to which the promotional communication fails to reveal facts material in light of the representations made or with respect to consequences that may result from the use of the drug as recommended or suggested in the promotional communication,” said FDA.

FDA noted that Slynd is contraindicated for women with renal impairment, those with a history of cervical cancer, liver tumor and other conditions. The agency also listed a slew of side effects associated with the drug, including acne, weight gain, nausea and vaginal hemorrhaging. However, Exeltis’ social media post listed none of those issues.

“By omitting the risks associated with Slynd, the post fails to provide material information about the consequences that may result from the use of Slynd and creates a misleading impression about the drug’s safety,” said the agency.

FDA also argued that Exeltis made false or misleading claims about the efficacy of Slynd by stating it could offer patients estrogen-free birth control with “periods on a schedule.” The agency said the company overstated the ability of the drug to predict when women on Slynd will have a period.

On the contrary, regulators said that based on data from clinical trials, most women using the pill did not have a predictable period, and the predictability of their periods actually decreased after taking it.

“Therefore, due to the majority of patients not experiencing scheduled bleeding (as would be expected during a menstrual cycle) during treatment with Slynd and the large proportion of patients still experiencing breakthrough bleeding, claims regarding Slynd patients experiencing predictable or ‘scheduled periods’ are not supported by the data,” said FDA. “If you have information or data to support periods occurring on a schedule, please submit to FDA for review.”

Finally, FDA cited Exeltis for failing to submit a Form FDA-2253 after making the Facebook post.

“FDA regulations require any labeling or advertising devised for promotion of the drug product to be submitted at the time of initial dissemination of the labeling and at the time of initial publication of the advertisement for a prescription drug product,” said the agency. “Each submission is required to be accompanied by a completed transmittal Form FDA-2253 (Transmittal of Advertisements and Promotional Labeling for Drugs for Human Use) and is required to include a copy of the product’s current professional labeling.”

FDA asked Exeltis to stop any further promotional activity that would violate regulations and respond to the agency within 15 days of getting the letter to state what it is doing about rectifying the situation or why it thinks it’s not in violation of regulations.

Untitled letter

Facebook post prompts untitled letter to birth control maker Exeltis

Related topics

Recommended content

Welcome to the new RAPS Digital Experience