• where experts go to learn about FDA
  • Dara Katcher Levy

    • A (Not So) New Avenue to Challenge Misleading Rx Promotion – NADJanuary 25th, 2023

      (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 …

    • The PIE Act – A Win for Patients, Payors, and SponsorsJanuary 5th, 2023

      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 …

    • Back to Basics with the Jackson 5 – It’s ABC, as easy as 1, 2, 3: OPDP Issues the Most Unsurprising Untitled Letter of the YearJune 9th, 2022

      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 …

    • Is It News? Is It Promotion? OPDP’s Latest Letter Shines a Light on Native AdvertisingMay 4th, 2022

      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, …

    • Fake News? Fantastic Claims and Where to Find Them (or Where FDA Will)March 4th, 2022

      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 …

    • But Is It Insta-Worthy? OPDP’s First Letter of 2022February 7th, 2022

      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 …

    • It Takes Three [Components] to Make a Thing Go Riiiiiight – OPDP Challenges Two-Part AdJanuary 26th, 2022

      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 …

    • Is Facebook Ghosting Pharma?September 1st, 2021

      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 …

    • Facebook “Pokes” Pharma Companies, Telehealth, and Online PharmaciesAugust 6th, 2021

      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 …

    • What’s in a name? FDA Calls out Amgen for MisdirectionJuly 16th, 2021

      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 …

    • Keeping Up With the Kardashians – OPDP EditionMarch 11th, 2021

      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 …

    • OPDP Issues Second Warning Letter of 2021. But Wait, Where Did the OPDP Warning Letters Go?March 2nd, 2021

      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 …

    • “Tongue and Done” – Just . . . No.February 18th, 2021

      Yesterday’s FDA Warning Letter, Press Release, and accompanying public relations campaign related to AcelRx’s promotional material for Dsuvia (sufentanil) are remarkable for exactly the reasons FDA intended them to be remarkable: these actions all signal to industry that despite anemic levels of FDA enforcement related …

    • Office of Prescription Drug Promotion Announces New Process for Core Launch ReviewNovember 27th, 2020

      On November 20, 2020, the Office of Prescription Drug Promotion (OPDP) hosted a webinar to announce a new process for review of “core launch” promotional materials.  Specifically, OPDP has added a five business day screening period to the beginning of core launch review to ensure …

    • What Device Manufacturers Need to Know at This Time about FDA’s Exercise of Emergency Authority in Response to COVID 19March 27th, 2020

      FDA is exercising significant emergency authorities during the COVID‑19 pandemic.  Not all of industry is affected, but those who are manufacturing or distributing (or using) devices being used to fight the pandemic can benefit by understanding FDA’s emergency‑related policies and practices.  These are evolving every …