Sprout Pharmaceuticals is once again under fire from the FDA’s Office of Prescription Drug Promotion (OPDP).
The OPDP issued a warning letter to the drugmaker—dated May 29 and publicly released this week—to express concerns over an Instagram post from Sprout’s CEO about Addyi, the company’s prescription pill for hypoactive sexual desire disorder (HSDD) in women.
The post in question is from July 1, 2024. Cindy Eckert, Sprout’s CEO and founder, shared a screenshot of a People magazine article in which a woman shared her positive experience with Addyi; the article brands Addyi as “the sex pill for women.”
In her caption accompanying the post, Eckert wrote in part, “This has never been about a pill at all. This is about dismantling a double standard that shouldn’t have been there in the first place.”
She added, “The first articles on [Addyi] a decade ago questioned the women struggling, told them it was normal, debated how many more satisfying sexual events were enough for them to deserve a pill…Today People Magazine let a woman speak for herself. I hope it helps countless others.”
The OPDP took issue with the post being promotional in nature without also including information about Addyi’s risks, limitations and full indication. Without the full picture, the post is “false or misleading,” according to the agency.
The “sex pill for women” claim included in the post, for example, may mislead viewers by incorrectly suggesting that Addyi is prescribed to enhance sexual performance; as the warning letter noted, the drug is indicated only as a treatment for specific cases of acquired, generalized HSDD, while its limitations of use specifically say it’s “not indicated to enhance sexual performance.”
The drug marketing watchdog took issue with the violation for multiple reasons. For one, the OPDP wrote in the letter, it’s “especially problematic from a public health perspective” since Addyi offers “a number of serious risks, including a boxed warning due to the risk of severe hypotension and syncope in certain settings.”
Indeed, when Addyi was approved by the FDA in 2015, it came with a black box warning about the risk of low blood pressure and fainting if Addyi was taken with alcohol or certain CYP3A4 inhibitors, or by patients with hepatic impairment. The regulator also barred Sprout from conducting any radio or TV marketing of the drug for its first 18 months on the market.
The OPDP also referred to another warning letter sent to Sprout in 2020, writing that it is “concerned that … Sprout continues to promote Addyi in a similarly misleading manner.”
The 2020 letter focused on a radio ad that included “numerous claims and presentations regarding the benefits of using Addyi." The spot failed to list all of the drug’s risks and contraindications, the OPDP wrote at the time.
To address its latest concerns, the OPDP has given Sprout 15 days to submit a written response detailing how it plans to either discontinue any misleading promotional materials for Addyi or cease distribution of the drug altogether.
The agency also asked Sprout to provide a plan for disseminating “truthful, non-misleading, and complete corrective communication(s) about the concerns discussed in this letter” to anyone who may have seen Eckert’s Instagram post.
Sprout did not immediately respond to Fierce Pharma Marketing’s request for comment.