OPDP Coming Out! New Untitled Letter, Old IssueAugust 23, 2023
OPDP is coming out! On the heels of a nuanced and more complicated Warning Letter addressing CFL claims and statistical presentations comes a new Untitled Letter from OPDP going back to its roots! This most recent Untitled Letter to Exeltis alleges omission of risk information as well as misleading efficacy information in a promotional social media post and Exeltis’s failure to submit on 2253. Honestly, the most surprising thing about this letter was its timing – issued only a week after OPDP’s first Warning Letter in well over a year making this newest Untitled Letter OPDP’s third letter in just over two months after a year hiatus.
So, what gives?
The letter itself is pretty typical of what we would expect to see from OPDP – prioritizing a communication that includes no safety information despite numerous efficacy claims, calling out an efficacy claim as misleading, and failing to submit promotional material on Form 2253. Top it all off with an underlying promotional piece that is a sponsored social media post and we have lots of things that could be triggers for an OPDP Untitled Letter.
But… it’s the failure to submit on Form 2253 that’s giving this blogger trade complaint vibes. And quite frankly, I think that’s the most interesting part of the story (please indulge some completely speculative musings here).
In January this year, six months after the last enforcement letter from OPDP, we blogged on a decision from the National Advertising Division (NAD) about misleading claims made in Rx drug promotion. At the time, we spoke with Laura Brett, Vice President and New York Office Leader at BBB National Programs who confirmed that NAD has always been able to review prescription pharmaceutical claims, even if it has been underutilized in doing so. NAD appeared to be inviting pharmaceutical companies to leverage its processes and submit complaints. We speculated that, “[g]iven the drop in OPDP enforcement letters, NAD may represent a new venue for industry looking to challenge competitor Rx drug DTC advertising claims.”
A few months later there was more NAD news on the Rx drug promotion front: ViiV Healthcare, the subject of a competitor complaint submitted to NAD, declined to participate in NAD’s self-regulatory process as, according to NAD, ViiV indicated that “FDA is best positioned to assess the appropriateness of these prescription drug claims.” The trade press was reporting that ViiV told NAD it provided FDA with notice of its claims, it had submitted promotional materials to FDA, and implemented FDA comments in its promotion. Wow. That news certainly took the NAD option down a few notches for industry in terms of alternative approaches for trade complaints.
Six weeks after the NAD/ViiV brouhaha, and about a year since its last letter, OPDP issued its first letter of 2023, citing misleading claims about efficacy and risk. While not raising too many eyebrows given the subject matter, the letter appears to have opened the proverbial floodgates given that we now have 3 OPDP letters in a span of just over 2 months. And, with my confusion over the “priority” of issuing a Warning Letter to AstraZeneca for its page 7 presentation in a 12-page healthcare professional brochure, after this newest letter, I couldn’t help but wonder [insert Carrie Bradshaw gif here – lol] whether these letters may share another common priority stated by FDA – the drugs were cited in complaints to the agency. Did OPDP just stumble across Exeltis’s Facebook post for Slynd (it wasn’t submitted via Form 2253)? Did OPDP just randomly check a 2253 submission of a 12-page healthcare professional brochure to find the promotion cited in its recent Warning Letter? Can we expect more enforcement from OPDP in 2023 in response to trade complaints?
These are just some of the questions from this blogger. Maybe industry doesn’t need NAD after all – maybe OPDP is “back.”