• JP Ellison

    • 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 …

    • Deputy Attorney General’s Speech Highlights Changes in How DOJ Investigates and ProsecutesSeptember 19th, 2022

      In a speech last week, Deputy Attorney General Lisa Monaco touched on a number of topics that should interest readers of this blog.  First, although the topic of her speech was corporate criminal enforcement, DAG Monaco stressed that DOJ’s “number one priority is individual accountability.”  …

    • “The Name’s Bond. James Bond.”: DOJ Requires Companies to Identify All Responsible IndividualsNovember 15th, 2021

      It may be just a coincidence that DOJ released its latest policy pronouncement at the same time as the final “Daniel Craig as James Bond” movie.  But like James Bond, companies in the crosshairs of a government investigation have No Time to Die, as they …

    • Giving Regulatory Due Diligence Its DueSeptember 2nd, 2021

      The adage that “no one is perfect” applies as equally to companies as it does to people.  Before committing to a merger or acquisition with another company, a potential Buyer must conduct due diligence to identify the imperfections of a target company so the Buyer …

    • DOJ Re-Brands Guidance DocumentsAugust 30th, 2021

      Companies often use rebranding to reposition and refocus their business.  Sometimes they do it with great fanfare; sometimes it is done quietly and incrementally.  The federal government does its own version of rebranding with each change in administration.  Just before the July 4 holiday weekend, …

    • FIFA Cases Hold Lessons for FDA-Regulated Companies – Organizations can be Victims of Their Own Employees’ Criminal ConductAugust 26th, 2021

      It is a well-accepted fact that even well run ethical and compliant organizations can have serious problems.  The Sentencing Guidelines, the DOJ Manual, and the HHHS OIG–among others–all recognize that reality.  In its Compliance Guidance for Pharmaceutical Manufacturers, the HHS OIG notes: The OIG recognizes that …

    • In Seventeen Years will the Cicadas Around FDA’s White Oak Campus Find Complete Culinary Acceptance? Stay TunedJune 3rd, 2021

      As has been widely covered in local and national press in and around the Washington, DC area, this month marks the once every seventeen year emergence of the Brood X cicadas.  These insects are so plentiful in local areas with trees, including FDA’s aptly named …

    • AMPed up—again– over Medicaid Rebate False Claims Act allegationsApril 13th, 2021

      Earlier this month, the Department of Justice announced another settlement in a Medicaid Rebate False Claims Act (FCA) case.  In this case, United States ex rel. Streck v. Bristol-Myers Squibb Co., Civil Action No. 2:13-CV-7547 (E.D. Pa)  Bristol Myers Squibb (BMS) agreed to pay $75 …

    • Cert-ainly Interesting Times for the FTC at the Supreme CourtJanuary 13th, 2020

      On December 19, 2019, the Federal Trade Commission (“FTC” or the “Agency”) filed a petition for writ of certiorari in the Supreme Court seeking review of a ruling by the Seventh Circuit case FTC v. Credit Bureau Center, LLC.  A detailed overview of the background …

    • The FTC Loses Big in the Seventh CircuitAugust 26th, 2019

      In the August 21 split panel decision issued in Federal Trade Commission v. Credit Bureau Center LLC, the Seventh Circuit held that section 13(b) of the Federal Trade Commission Act (“FTCA”), 15 U.S.C. § 53(b), does not authorize an award of restitution.  In overturning its …

    • Hi-Tech Sues to Save DMHAMay 6th, 2019

      Hi-Tech Pharmaceuticals, Inc. (Hi-Tech) and its President and Chief Operating Officer filed suit in the U.S. District Court for the District of Columbia to enjoin FDA from continuing to seek removal of DMHA products from commerce through the issuance of warning letters and “pressure… to …

    • Is the Government All Fired Up About Charging Individuals?April 11th, 2019

      We have long posted about the government’s threats to hold individuals liable for actions taken on behalf of their companies, for example here, but these actions remain rare and typically are reserved for egregious, repeated, and intentional criminality.  A recent indictment against two former executives, …

    • Judge Says Lack of State and Federal Plans Means That the Farm Bill’s Interstate Commerce Protections for Hemp Don’t ApplyApril 9th, 2019

      We previously posted about what the Agricultural Improvement Act of 2018 (commonly referred to as the Farm Bill) did, and did not, do with respect to “hemp” and CBD products derived from hemp.  In that post, we noted that the Farm Bill did not preempt …

    • A Pair of FDC Act-Related Convictions Upheld on Appeal in the Eighth and Eleventh CircuitsJanuary 10th, 2019

      In two unrelated cases, two U.S. Courts of Appeal affirmed FDC Act-related convictions earlier this week.  In United States v. Patino, the Eighth Circuit held that it was not an abuse of discretion to allow the government to introduce, in connection with a 2016 prosecution …

    • Putting the “Complete” Back into Complete Response LettersOctober 25th, 2018

      A biotech company facing a complete response letter (CRL) action on its NDA/BLA has no greater goal than to quickly and fully understand the deficiencies that FDA has identified in the application.  Such an understanding is critical to addressing the review division’s findings through additional …