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  • Advertising and Promotion (OPDP)

    • HP&M’s Jeff Shapiro and Serra Schlanger to Present on Advertising and PromotionSeptember 23rd, 2021

      Hyman, Phelps & McNamara, P.C. is pleased to announce that Jeffrey Shapiro and Serra Schlanger will present at this year’s Food and Drug Law Institute virtual Advertising and Promotion for Medical Products Conference on October 13–15.  This conference will analyze the latest regulatory issues related …

    • 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 …

    • PhRMA Code Revised in Response to OIG Special Fraud Alert on Speaker ProgramsAugust 24th, 2021

      On August 6, 2021, the Pharmaceutical Research and Manufacturers of America (PhRMA) announced the release of a revised PhRMA Code on Interactions with Health Care Professionals, which takes effect on January 1, 2022.  The PhRMA Code is a voluntary code of conduct focusing on the …

    • 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 …

    • OIG Fires Another Warning Shot at Drug and Device Companies’ In-Person Speaker ProgramsNovember 19th, 2020

      On Monday, the Office of Inspector General (OIG) at the U.S. Department of Health and Human Services (HHS) issued a Special Fraud Alert highlighting “some of the inherent fraud and abuse risks” associated with in-person speaker programs, a widely used channel to educate physicians and …

    • HP&M’s Dara Levy and Serra Schlanger to Present on Advertising and PromotionOctober 16th, 2020

      Hyman, Phelps & McNamara, P.C. is pleased to announce that Dara Katcher Levy and Serra Schlanger will present at the Food and Drug Law Institute’s virtual Advertising and Promotion for Medical Products Conference on October 28–30, 2020.  This conference will analyze the latest commercial issues …

    • Swift Enforcement Against COVID FraudstersMay 1st, 2020

      Since HHS declared a public health emergency caused by COVID-19 in February 2020, there has been an overwhelming response to develop and market products to treat or mitigate the effects of the virus.  Unfortunately, bad apples still are out there preying upon consumer fears and …

    • Too Much, Too Soon: OPDP Issues Untitled Letter for Pre-approval PromotionNovember 25th, 2019

      Just as many object to holiday music in November, the Office of Prescription Drug Promotion (“OPDP”) objected in an untitled letter issued earlier this month to claims made for an investigational drug.  The statements (since removed) appeared on a company website about an investigational drug …

    • Note to Pharma: Stop With the Dancing! (And Get Off My Lawn)August 19th, 2019

      After reading OPDP’s latest enforcement letter, we had déjà vu all over again and were transported back to 2016 when we blogged that OPDP was Not Dead Yet.  At that time, OPDP had posted two enforcement letters on the same day relating to TV ads …

    • Rule to Require Drug Prices in TV Ads Found InvalidJuly 9th, 2019

      On July 8, 2019, U.S. District Court Judge Amit P. Mehta struck down a recently finalized Centers for Medicare & Medicaid Services (CMS) rulethat would have required drug pricing disclosures to be included in television advertisements for certain prescription drugs and biological products (the “Price …