• where experts go to learn about FDA
  • Advertising and Promotion (OPDP)

    • HP&M Director Anne Walsh to Share Global Ad Promo Insights at the DIA Advertising and Promotion Regulatory Affairs ConferenceMarch 4th, 2024

      Hyman, Phelps & McNamara, P.C. (HP&M), is pleased to announce that Director Anne Walsh will be speaking at the DIA Advertising and Promotion Regulatory Affairs Conference. This essential event for regulatory professionals in the biopharmaceutical and medical device industries will take place March 12-13, 2024, …

    • ACI’s 42nd FDA Boot Camp – New York City EditionJanuary 24th, 2024

      The American Conference Institute’s (“ACI’s”) popular “FDA Boot Camp”—now in its 42nd iteration—is scheduled to take place from March 13-14, 2024, at the SpringHill Suites NY Manhattan Times Square South, New York. The conference is billed as the premier event to provide folks with a …

    • OPDP’s One-Two Combo on Quantitative Efficacy Claims in DTC AdsDecember 19th, 2023

      It has been a few weeks, but we thought it important to do a deeper dive on the two Office of Prescription Drug Promotion (OPDP) Untitled Letters published in November.  The letters, both issued on October 31, 2023 but published in early November, were to …

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      Yesterday, FDA published a new Draft Guidance, “Communications from Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers” (SIUU Guidance or Draft Guidance).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

    • 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 …

    • FDORA Enacted; HP&M Issues Detailed Summary and AnalysisJanuary 23rd, 2023

      On December 29, 2022, the President signed into law the Food and Drug Omnibus Reform Act of 2022 (“FDORA”) as part of the Consolidated Appropriations Act, 2023, Pub. L. No. 117-328 (2022).  FDORA primarily amends the Federal Food, Drug, and Cosmetic Act and the Public …

    • 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 …

    • ACI’s FDA Boot Camp – September 14-15, 2022 (Virtual)August 5th, 2022

      The American Conference Institute is hosting their 39th FDA Boot Camp from September 14-15, 2022.  The conference will be held virtually. Gain insight and training in core regulatory concepts for life sciences attorneys, business executives, and policy analysts. The approval process, pre-approval concerns, product labeling, clinical trials, …

    • HP&M’s Dara Katcher Levy to Present at DIA 2022 Global Annual Meeting on Healthcare Economic InformationJune 16th, 2022

      Hyman, Phelps & McNamara, P.C.’s Dara Katcher Levy will be presenting at the DIA 2022 Global Annual Meeting being held this June 19-23 in Chicago, IL.  Dara will be joining an expert panel as part of the Medical Affairs and Scientific Communications Track to discuss manufacturer communications …

    • 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 …