|Footnotes for this article are available at the end of this page.
Well, that was fast. Fresh off issuing its first Warning Letter of 2021,1 the Food and Drug Administration’s Office of Prescription Drug Promotion (“OPDP”) struck again. OPDP sent the Warning Letter to the drug company a day after issuing the first. If the agency keeps this pace, we will be preparing a number of Bulletins in 2021.2 The second Warning Letter includes many recurring themes of unlawful promotional areas. In addition, OPDP sent an Untitled Letter to the company in 2019 for similar concerns. It reminds us of the Crosby, Stills, Nash & Young classic song, “Déjà Vu,” and the ending lyric, “We have all been here before.” Or, as the great philosopher, Yogi Berra once said, “It’s like déjà vu all over again.”
Here are a few highlights of the Warning Letter:
- The promotional piece was a direct-to-consumer video, shown on a television station.
- OPDP became aware of the video through a Bad Ad complaint.
- The video did not provide any risk information, even though it promoted the product’s efficacy. While the video referred the viewers to the product website for additional information, OPDP found “that does not mitigate the complete omission of risk information from the video.”
- As noted, OPDP sent the company an Untitled Letter about a DTC television ad that failed to include risk information. OPDP wrote, “[the company] appears to be promoting [product] without presenting the serious risks of the drug in a truthful and non-misleading manner, despite concerns previously expressed by OPDP.”
- The company did not submit the video to OPDP on a Form FDA-2253, which is required for all promotional materials at the time of initial dissemination of the labeling or at the time of initial publication of the advertisement.
- The company must take corrective action to be directed to the same audience that received the violative messaging.
- We feel like we have all been here before, to paraphrase CSN&Y. The issues raised by OPDP should not be new to industry, and we have written about these in previous Bulletins. We have advised clients on these topics, whether during Promotional Review Committee participation or through general day-to-day counseling.
- It is inadequate for companies to promote positive safety and efficacy claims and then direct users to another place to view risk information. One must provide a fair balance at the same time.
- The Bad Ad campaign was mentioned as the source of the complaint in this case. Perhaps, because of the pandemic, OPDP officials are becoming more reliant on the Bad Ad campaign to learn of unlawful promotional messaging.
- Don’t forget that 2253 submissions are required when distributing product promotions.
- It is too early to tell whether OPDP intends to issue more Warning Letters than Untitled Letters this year but, so far in 2021, we have two Warning Letters. In the second case, though, the company received an Untitled Letter in 2019, so the Warning Letter was likely a result of OPDP’s displeasure with the recurring non-compliance.
- The violations cited in the Warning Letter are a reminder of some concepts to review when evaluating promotional materials for compliance. The issuance of two Warning Letters, to date, demonstrates that OPDP is not letting the pandemic slow it down.
 See our Bulletin: Meet the New Boss, Same as the Old Boss: OPDP Issues Its First Letter of 2021.
 The Warning Letter can be accessed at www.fda.gov./inspections-compliance-enforcement-and-criminal-investigations/warning-letters/coopersurgical-inc-613339-02122021.