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  • Advertising and Promotion (OPDP)

    • 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 …

    • First Amendment Considerations Addressed (and Rejected) in FDA MemorandumJanuary 23rd, 2017

      It feels like déjà vu. In 2011, FDA announced the establishment of a docket to evaluate its policies on communications and activities related to off-label uses of marketed products; late in 2014, FDA committed to issuing new guidance by the end of 2014 to address …

    • OPDP Doubles Enforcement Letters, But is Carefully Picking Its BattlesJanuary 20th, 2017

      After a relatively slow first 11 months of 2016, FDA’s Office of Prescription Drug Promotion (“OPDP”) issued a flurry of letters in the span of 9 days in December, more than doubling the enforcement letters issued up to that point in the year. And the …

    • Not Dead Yet – OPDP Issues Two Untitled Letters Late in the Year (Our 3,000th Post!)December 18th, 2016

      Your friendly neighborhood bloggers were tempted to headline this post with a Buzzfeed worthy headline such as “When FDA pointed out THIS ONE THING, industry was SHOCKED!” or “FDA issues flood of letters – 25% of 2016 output in a single day.  What happened next …

    • FDA To Hold Two-Day Hearing on Off-Label CommunicationsSeptember 1st, 2016

      By Anne K. Walsh & Andrew J. Hull – FDA announced in an August 31, 2016 notification (“Notification”) that it will convene a public hearing to address its authority to regulate communications regarding unapproved uses of approved or cleared drugs and medical devices. The public hearing …