Well, if you, like many within industry, felt emboldened to disseminate promotional materials that may push the envelope on efficacy (so long as your risk information was tight) think again! OPDP is back in the game, letting all the people know that they are back …
After about a year without any untitled letters from OPDP, Xeris Pharmaceuticals received an untitled letter for their promotion for Recorlev (levoketoconazole) for misleading safety and efficacy claims. To quote everyone’s favorite flautist (and TikTok sensation) Lizzo, “it’s about d@mn time!” (Sorry for the bowdlerization, …
The Academy of Managed Care Pharmacy (AMCP)’s Format Executive Committee is excited to let you know that after two years of work, version 5.0 of the Format for Formulary Submissions (also known as dossiers) is on the horizon. And we need your feedback! We’ve included …
(Caution: Links in the first paragraph are a wild musical ride. Click at your own risk) For those of you that review Rx ad/promo materials, it’s a familiar scenario: Marketing has come to the Legal Department with significant concerns about competitor activities – consumers are being …
A win for patient access! Prescription drug and medical device Pre-Approval Information Exchange (PIE) now has specific legal protection allowing for sponsors to proactively communicate to payors certain information about products in development to help expedite patient access upon product approval. The PIE Act, otherwise known …
While the Jackson 5 hit “ABC” predates even these rapidly aging bloggers (first performed on Dick Clark’s American Bandstand in 1970, and we challenge you to name all five members of the Jackson 5, we tap out after Michael, Tito, and Jermaine), its basic wisdom …
A few weeks back, OPDP issued its second Untitled Letter of 2022 (third letter in 2022 overall) to Bausch Healthcare alleging violative DTC and HCP promotional communications for Duobrii (halobetasol priopionate and tazarotene) lotion. Of interest (to me) is the DTC communication cited where OPDP, …
With our second OPDP enforcement letter of 2022, FDA is making one thing clear: OPDP will find your promotional content—even when it may not look like promotional content. While it’s not mind-blowing that OPDP would find a series of videos while scrolling Instagram (particularly when …
Well, OPDP is kicking off 2022 in a big way – taking on an Eli Lilly Instagram post with video for Trulicity. This is the second time in a little over a month that Eli Lilly has found itself caught in OPDP’s cross-hairs. On the …
We are working to keep up with OPDP’s posts over the past few weeks and a blog on its most recent letter to Lilly is forthcoming! With apologies to Rob Base and DJ EZ Rock, it took more than “two” to get this Emgality DTC TV …
In what appears to be an “about face” in terms of Facebook’s historical wooing of big pharma (are we the only ones that immediately thought, “More Cowbell” when seeing that headline? You can thank us for that 5 minute rabbit hole later), the social media …
We are old enough to remember the “poke” function on Facebook, and too old to remember what purpose it served. We are similarly at a loss to understand the purpose of Facebook’s new policy requiring that pharmaceutical manufacturers, telehealth companies, and online pharmacies apply for …
In case you missed it, FDA took to email and social media earlier this week (the equivalent of shouting it from the rooftops) to announce that it has notified Amgen Inc. of Neulasta (pegfilgrastim) misbranding due to false or misleading promotion. This is OPDP’s second …
I would be lying if I said I hadn’t expected this most recent OPDP Untitled letter. OK, maybe not THIS letter. Some background: Back in November 2020, after an article was published about the ethical questions surrounding “Sponcon,” (sponsored content – for those not hip …
Well, it’s been busy for OPDP (and the Rx Ad/Promo bloggers over at the FDA Law Blog). After getting off to a slow start in 2021, OPDP issued yet another Warning Letter, apparently the day after its first. Unlike the first letter, this OPDP Warning …
