|Footnotes for this article are available at the end of this page.
In his 1973 song, “Nostradamus,” singer-songwriter Al Stewart sang, “I am the eyes of Nostradamus, all your ways are known to me.”1 So, we started thinking, what would Mr. Stewart think of FDA’s Office of Prescription Drug Promotion’s latest Untitled Letter? Do two Untitled Letters in two months from OPDP make a trend? What about a Warning Letter and an Untitled Letter in back-to-back weeks?2 As a client asked, “Is the beast awakening?” We are not Nostradamus, so we will not speculate, but it does look like OPDP may have gotten a second wind during the summer months.
- OPDP objected to a company-sponsored Facebook post about a prescription progestin indicated for use by females of reproductive potential to prevent pregnancy. It is contraindicated for certain individuals, including females with “undiagnosed abnormal uterine bleeding,” and has a number of warnings, precautions, and adverse reactions. 3
- The post discussed benefits of the drug product but did not provide any risk information.
- The claim, “offer your patients estrogen-free birth control with periods on a schedule,” overstated the product’s efficacy by claiming patients will have a “period,” or bleeding, that is predictable and “on a schedule” when there was no substantiating data to support it.
- OPDP referred to the product PI, which noted that the majority of patients did not experience “periods on a schedule” over the duration of treatment. Instead “periods on a schedule” decreased.
- The company failed to submit a Form FDA-2253, which is required to be submitted at the time of initial dissemination of the labeling and at the time of initial publication of the advertisement.
- OPDP reviewed the social media post on August 5, 2023, and issued the Untitled Letter on August 11, 2023 — that’s fast.
- Providing no risk information in product messaging, particularly in a direct-to-consumer forum such as Facebook, is an easy target for OPDP.
- Companies post social media ads frequently and often in short periods of time. As we remind clients in counseling and during the many Promotional Review Committees we serve, such posts must be reviewed internally for compliance and submitted on a Form 2253. Even minor changes to posts must be reviewed and each message considered for 2253 submission.
- We are not Nostradamus (or Al Stewart), but we can predict that social media posts and messaging without any risk information will continue to face OPDP scrutiny. As for an OPDP-awakening beast or a sign of things to come, we don’t think even Nostradamus would make a prediction.
 Mr. Stewart is also known for his classics “Year of the Cat” and “Time Passages.”
 We prepared Bulletins on the previous Untitled Letter and Warning Letter, which can be accessed here and here.
 The Untitled Letter can be accessed at https://www.fda.gov/drugs/warning-letters-and-notice-violation-letters-pharmaceutical-companies/untitled-letters-2023.