• where experts go to learn about FDA
  • Jeffrey N. Wasserstein

    • Biogen agrees to pay $900 million in largest FCA Settlement Ever Secured without Government’s InterventionOctober 2nd, 2022

      On September 26, 2022, Biogen Inc. agreed to pay $900 million to the United States and various states to settle a False Claims Act (FCA) lawsuit.  This lawsuit was brought to the U.S. district court of Massachusetts by former employee and whistleblower Michael Bawduniak in …

    • No Walk in the Park: JAMA Editorial Calls for More Park Prosecutions; We DisagreeSeptember 22nd, 2022

      In a recent JAMA editorial (unfortunately behind a paywall), three authors called for increased use of the Park Responsible Corporate Officer doctrine, under which senior level officials at a company can be held liable under a strict liability theory even if they were not involved …

    • Patient Groups Sue HHS, CMS for 2020 Rule Allowing the Use of Copay Accumulator ProgramsSeptember 8th, 2022

      Three patient advocate groups have sued the Department of Health and Human Services (HHS) and the Centers for Medicare and Medicaid Services (CMS), challenging HHS’s 2020 Notice of Benefits and Payment Parameters (NBPP) rule.  As it stands, the rule allows insurers and pharmacy benefit managers …

    • 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 …

    • 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 …

    • District Court Interprets EKRAJanuary 7th, 2022

      “EKRA” refers to the Eliminating Kickbacks in Recovery Act, which was part of the Substance Use – Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018.  EKRA is codified at 18 U.S.C. § 220 and was described on HP&M’s …

    • 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 …

    • “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 …

    • OIG Finalizes Safe Harbor Amendments Relating to Rebates, but Benefits to Patients Are UnclearDecember 8th, 2020

      As part of its final push to lower drug prices, the Trump administration announced that it was finalizing a January 2019 proposed rule to amend the safe harbor provisions relating to manufacturer rebates to Medicare Part D plans, Medicaid Managed Care Organizations (MCOs) and their …

    • 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 …

    • AdvaMed Updates Code of EthicsJanuary 17th, 2019

      On January 9, 2019, the Advanced Medical Technology Association (AdvaMed) announced updates to its “Code of Ethics on Interactions with Health Care Professionals” (Code).  The Code was last updated in 2008; the newest updates will become effective on January 1, 2020. The Code includes new sections …

    • Maryland AG Seeks SCOTUS Review of Generics Price-Gouging Prohibition Struck Down by Fourth CircuitOctober 26th, 2018

      Maryland Attorney General (“AG”) Brian Frosh is not going down without a fight in his bid to defend a Maryland law prohibiting “price gouging” by generic pharmaceutical manufacturers. H.B. 631, 437th Gen. Assemb., Reg. Sess. (Md. 2017) (hereinafter, “HB 631”), was passed by the Maryland …

    • 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 …

    • CMS Finalizes National Coverage Determination for Next Generation Sequencing TestsMarch 20th, 2018

      On March 16, 2018, the Centers for Medicare and Medicaid Services (CMS) finalized a new National Coverage Determination (NCD) for Next Generation Sequencing (NGS) tests.  The granting of the new NCD resulted from the FDA – CMS Parallel Review of Foundation Medicine, Inc.’s FoundationOne CDx™ …

    • OIG Issues an Advisory Opinion on Providing Replacement ProductAugust 28th, 2017

      In an advisory opinion posted on August 25, 2017, the Office of the Inspector General of the Department of Health and Human Services (“OIG”) determined that enforcement action would not be taken against a drug manufacturer’s proposal to replace products that require specialized handling that …