FDA Sends Warning Letter To Sprout Pharma For Social Media Post
June 16th, 2025 // 1:43 pm @ jmpickett
Last week, FDA sent a warning letter to Sprout Pharmaceuticals, Inc. for a social media post that promoted ADDYI or flibanserin. The Instagram post discussed Addy’s benefits but did not mention important safety information and related details for the target population. The agency said the CEO Cindy Eckert, shared a People magazine screenshot where a woman shared a positive experience with Addyi, where the drug was branded ‘the sex pill for women.’
The caption quoted Eckert, ‘This isn’t about a pill at all, it’s about dismantling a double standard that never should have existed.’ The warning letter said the post was entirely promotional and didn’t include information about risks, full indication, or limitations.
We see this social media-related warning letter as another sign that FDA will focus more on drug promotions and advertising. There will likely be more warning letters targeting social media promotion and advertising that are sent to executives or personal social media accounts.
Addyi is the first medication approved by FDA to treat premenopausal women who have generalized, acquired hypoactive sexual desire disorder. However, it should only be used in limited populations and has many safety warnings required. One of them is a boxed warning for low blood pressure and fainting, especially when taken with certain medications or alcohol.
The Instagram post was shared on the CEO’s personal Instagram account. It included content from an article in People Magazine and the CEO’s statement about the article. FDA made it clear that it thinks a screenshot and user-generated content is one post. This is important to understand the context for this letter and understanding how the agency is thinking about these common types of social media posts.
Fair Balance
On the surface, the Instagram post has good intentions: The aim is to talk about female sexual dysfunction and encourage conversation about this seldom-discussed issue. The CEO’s social media post tells a personal story about a woman living with the condition. However, FDA requires any communication that states the name of a drug and discusses how it’s used must follow promotional requirements issued by the agency. FDA regulations mandate there be fair balance between information about the benefits and risks of the pharmaceutical.
FDA notes in the warning letter that there isn’t any fair balance at all; nothing is mentioned about the drug’s risks or indications. If Addyi didn’t have a boxed warning, the lack of safety language may have led to a less serious FDA response.
FDA took the CEO to task for promoting the drug generally for the sexual health of women, without adding usage and safety information. It left the impression that Addyi is safe and effective for a larger group of people than the agency has approved.
Limitations Of Use
FDA notes that per the indications of use section of the product labeling, Addyi is for treating premenopausal women with hypoactive sexual desire disorder. The symptoms are low sexual desire that causes interpersonal difficulty and stress. HSDD isn’t due to a psychiatric or medical condition, problems with the partner, or effect of another drug. Addyi isn’t for postmenopausal women, men, or to boost sexual performance.
The post doesn’t discuss the limitations of use for the drug, and more subtlely, the post makes a claim that it’s the sex pill for women, suggesting that Addyi boosts sexual performance and can be used by women generally.
FDA’s concern with the advertising is that once the drug and use are mentioned, FDA’s promotional rules are in effect. The content must state the drug’s approved uses and not mislead readers. In this case, the agency argues that the Instagram post gives the impression that the drug can be used by all women who want sexual improvements, regardless of their age or medical conditions. The reality is different – FDA has approved Addyi only for a certain patient population.
FDA stated at the end of the warning letter that the company must provide a detailed plan for providing truthful, non-misleading, and complete communciations to the public about the issues raised in the letter.
