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

    • From GRP to SIUU – the Evolution of FDA Guidance on Off-Label Dissemination of Scientific InformationOctober 24th, 2023

      Yesterday, FDA published a new Draft Guidance, “Communications from Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers” (SIUU Guidance or Draft Guidance).  Previous iterations of this guidance from 2009 and 2014 (blogged on here and …

    • OPDP Coming Out! New Untitled Letter, Old IssueAugust 23rd, 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 …

    • OPDP Comes out Swinging With A Warning Letter on Unsubstantiated EfficacyAugust 17th, 2023

      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 …

    • Lizzo has Thoughts: First Untitled Letter for Promotional Activities in a YearJune 14th, 2023

      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, …

    • AMCP Format for Formulary Submissions Revision – Comment Period Now Open!June 5th, 2023

      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 …

    • 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 …