FDA blasts Exeltis over 'misleading' social media post about birth control drug

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来源: FiercePharma

The FDA asked Exeltis to explain the plan for stopping such communications

The FDA has torn into Exeltis over a social media sponsored post for birth control pill Slynd, lambasting the drugmaker for leaving out all the risk information, making misleading efficacy claims and failing to submit the material at the time of initial publication.

Exeltis’ first mistake, according to the untitled letter sent by the FDA, was to make the social media post public without submitting the material to the agency. Under FDA regulations, ads designed to promote a drug product must be submitted at the time of publication. The FDA accused Exeltis of failing to submit the post and thereby breaching its regulations.

The post itself set off alarm bells once the FDA laid eyes on it. According to the FDA, the post lacked any information about the risks of Slynd, despite the label of the oral contraceptive describing warnings and precautions related to high potassium, blood clots, bone loss, cervical cancer and more.

“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,” the FDA wrote in the untitled letter.

The FDA found fault with the information Exeltis included in the post too. Members of the FDA’s Office of Prescription Drug Promotion picked out the claim “offer your patients estrogen-free birth control with periods on a schedule” as misleading. The FDA interpreted the claim as suggesting that people on Slynd have predictable periods. That “overstates” the efficacy of Slynd, according to the FDA.

FDA officials cited clinical data in the Slynd product information to support their argument. In one clinical trial, the proportion of patients with scheduled bleeding fell from 81.2% early in the study to 26.4% after 13 treatment cycles. The studies also linked Slynd to unscheduled bleeding and spotting.

“Due to the majority of patients not experiencing scheduled bleeding … 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,” the FDA wrote.

In the letter, which is dated August 11, the FDA told Exeltis to stop violating the Federal Food, Drug, and Cosmetic Act and gave the company 15 working days from the date of receipt to respond. The agency asked Exeltis to address its concerns, list other promotions that contain similar messages and explain the plan for stopping such communications.

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