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  • Advertising and Promotion (OPDP)

    • 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 …

    • ACI’s 33rd FDA Boot Camp – New York City EditionMarch 8th, 2019

      The American Conference Institute’s (“ACI’s”) popular “FDA Boot Camp” – now in its 33rd iteration – is scheduled to take place from March 25-27, 2019, at the Park Lane Hotel in New York, NY. The conference is billed as the premier event to provide folks …

    • It’s All in the Numbers: FDA Issues New Draft Guidance on Presenting Quantitative Efficacy and Risk Information in DTC PromotionOctober 18th, 2018

      What is “truthful and non-misleading” in prescription drug promotion is often in the eye of the beholder. And, when it comes to enforcement, FDA is usually the arbiter. Over the years, FDA has taken on a number of initiatives and invested significant resources to better …

    • OPDP Issues First Efficacy-Only Enforcement Letter in Over 3 YearsSeptember 3rd, 2018

      In its fourth enforcement letter of 2018, the Office of Prescription Drug Promotion (OPDP) takes aim at a marketed drug’s sell sheet solely on the basis of misleading efficacy claims, the first letter to do so in over 3 years. The letter, issued August 16 to …

    • Like Ma Bell, I’ve Got the Ill Communications: Final Guidances IssuedJune 20th, 2018

      Announced as another effort to improve patient access and address drug pricing, FDA recently finalized two guidance documents intended to facilitate better communication and negotiation with payors, formulary committees, and others: Medical Product Communications That Are Consistent With the FDA-Required Labeling – Questions and Answers: Guidance …

    • Slower than Molasses in January, FDA Moves to Provide Guidance on Product Communications by Pharmaceutical and Device ManufacturersMarch 2nd, 2017

      In January 2017, FDA issued two Draft Guidance documents concerning communications made by medical device manufacturers about information not expressly contained within a product’s labeling: Medical Product Communications That Are Consistent With the FDA-Required Labeling – Questions and Answers: Guidance for Industry [Draft] (January 2017), hereinafter …