Not a Second Time: FDA’s Office of Prescription Drug Promotion Issues a Warning Letter to a Company for Unlawful Promotion

The authors were thinking of the Beatles’ 1963 song, “Not a Second Time,” when we read the latest Warning Letter from the Food and Drug Administration’s Office of Prescription Drug Promotion. The company received a Warning Letter for similar concerns in 2020. OPDP issued this Warning Letter less than a month after its last letter.

In this Bulletin, we summarize FDA’s primary concerns in the Warning Letter and offer our observations.

Highlights

• FDA received several complaints regarding the company’s promotional activity through its Bad Ad Program.
• The Warning Letter addresses concerns regarding one specific post on the company CEO’s personal Instagram account.
• The post included claims regarding the benefits of the company’s product, but it did not contain any risk information, including a Boxed Warning.
• Additionally, the post did not contain the product’s full indication or the product’s limitations of use.
• Further, the company did not submit a Form FDA 2253 prior to the post’s dissemination.
• OPDP notes that these concerns are similar to its concerns addressed in the 2020 Warning Letter to the company.
• OPDP requested corrective actions to include identifying other pieces with similar messaging, discontinuing use of such communications, and disseminating corrective communication to the audience that received the social media post.

AGG Observations

• While it can occur, OPDP typically does not issue a Warning Letter for one specific non-compliant messaging piece. However, in this case, OPDP sent the company a Warning Letter in 2020.
• Similar to many other OPDP enforcement actions, the letter notes that this promotional post lacked any risk information.¹
• As we often counsel our clients, materials should ensure that the full indication is provided and, if the product has limitations of use, these should always accompany the indication.
• Several factors can increase FDA’s attention to violative promotion, such as multiple complaints through the Bad Ad Program, past action from OPDP, and a Boxed Warning product. If FDA has issued a Warning Letter previously, it will be more likely to issue a second Warning Letter if the violative activity continues.
• Further, this Warning Letter highlights that it does not matter if the promotion is made on a corporate, product-specific, or personal social media page. Individual social media pages can face FDA scrutiny for unlawful promotion and carry regulatory requirements (such as a Form FDA 2253 submission).
• Despite recent personnel layoffs, OPDP has issued many enforcement actions, indicating its continued focus on promotional activity.

Bringing it back to the Beatles, OPDP seems to be saying “not a second time” to this company, after it continued to promote its product in an alike manner to the activity addressed in a previous Warning Letter.

[1] Please see our other Bulletins on past enforcement action examples: Let’s Get Clinical: FDA Issues NOV Regarding Misleading Clinical Data Promotion; Haven’t Got Time for the Panel: OPDP Issues Its First Notice of Violation of 2025.