• where experts go to learn about FDA
  • Andrew J. Hull

    • What To Do When You Receive a DEA Order to Show CauseApril 23rd, 2025

      We published a version of this post several years back (see here), but recent updates to the law and trends in DEA enforcement merit a refresher.  The stakes are high when a DEA-registered practitioner, pharmacy, distributor, manufacturer, or other registrant receives an Order to Show …

    • Enforcement Under the New FDA: HPM to Host a Q&A Webinar on FDC Act Enforcement with Three Former Federal ProsecutorsApril 17th, 2025

      Hyman, Phelps & McNamara, P.C. is hosting a free webinar on recent and forward-looking enforcement under the Federal Food, Drug & Cosmetic Act on Thursday, May 1, 2025, from 12:00 p.m. to 1:30 p.m. (ET) (register here). Join us as HPM’s Anne Walsh moderates a panel …

    • Court Rejects Challenge to DEA ALJ Hearing Authority Over Removal PowerApril 11th, 2025

      Last month, we blogged on the Department of Justice’s (DOJ) abrupt announcement that it had determined that removal restrictions protecting administrative law judges (ALJs) were “unconstitutional” and that DOJ would no longer defend those removal restrictions in court.  We opined that while the impact of …

    • FDA’s Vape Ban Hits the Right Note: Supreme Court Says “Let It Be”April 7th, 2025

      Last week, the Supreme Court issued a unanimous decision in FDA v. Wages & White Lion Investments, LLC, No. 23-1038 (Apr. 2, 2025) that affirms FDA’s denial of authorization to market flavored vape products. This opinion, which overrules a Fifth Circuit decision that FDA had …

    • DOJ Position on Administrative Law JudgesMarch 6th, 2025

      Late last month, the Department of Justice filed a short statement regarding administrative law judges (ALJs).  The statement, issued by the Department’s Chief of Staff Chad Mizelle, states in its entirety: Today the Department of Justice determined that multiple layers of removal restrictions shielding administrative law …

    • DEA Pharmacy Decision Highlights Agency’s Thinking on Expert Credibility and Testimony, as well as Red Flag ResolutionFebruary 19th, 2025

      A recent DEA decision revoking the registration of a Louisiana pharmacy sheds light on the Agency’s approach to crediting one expert’s testimony over that of another expert during an administrative hearing.  The discussion of the Agency’s expectations of the form and substance of expert witness …

    • DEA Issues Decisions in Pharmacy CasesJune 18th, 2018

      Over the last couple of months, DEA has issued four decisions revoking the registrations of pharmacies (recall that DEA issued only one decision in 2017 involving a pharmacy). In February 2018, the Acting Administrator revoked the registrations of Trinity Pharmacy I, 83 Fed. Reg. 7220 …

    • DEA, Nunc Pro Tunc Rulings, and Hearings That Never HappenedJune 13th, 2018

      A couple of months ago, the DEA Acting Administrator issued an order revoking the registration of David A. Ruben, M.D., on the grounds of lack of state authority (the Arizona Medical Board suspended his medical license in 2017). The same doctor was the subject of …

    • Supreme Court Denies Cert. Petition Accusing Fifth Circuit of “Sabotage of Off-Label Enforcement”May 24th, 2018

      Last September, we posted on the Fifth Circuit’s decision to uphold summary judgment and award of costs in favor of Solvay Pharmaceuticals, Inc. in a False Claims Act (FCA) case (see post here). The relators pursued an FCA theory against Solvay based on allegations of …

    • Pennsylvania Appeals Court Affirms Preemption of State Law Claims Based on Off-Label MarketingMay 16th, 2018

      Last week, the Superior Court of Pennsylvania struck a blow to Appellant Joseph Caltagirone’s wrongful death and survival claims against drug manufacturers Cephalon, Inc. and Teva Pharmaceuticals, USA, Inc. The Superior Court’s non-precedential decision relied on federal preemption principles to affirm the trial court’s dismissal …

    • DePuy Petitions Supreme Court to Weigh in on FCA Pleading StandardsMarch 22nd, 2018

      Last year, the First Circuit reversed the dismissal of a False Claim Act (FCA) case brought against DePuy Orthopaedics, Inc., holding that the district court had wrongly dismissed the relators’ complaint for failing to plead with particularity under Federal Rule of Civil Procedure 9(b) (see …

    • New DOJ Memo Discusses Factors for Dismissing FCA CasesJanuary 25th, 2018

      The Department of Justice recently issued a memo to all attorneys in the Commercial Litigation Branch, Fraud Section, and any Assistant U.S. Attorneys handling False Claims Act (FCA) cases, directing those attorneys to seek dismissal of FCA cases under certain circumstances. While the government’s ability …

    • DEA Administrative Decisions: 2017 in ReviewJanuary 12th, 2018

      It was a somewhat unsettling year for the Drug Enforcement Administration. The Agency faced a barrage of criticism in the press regarding its involvement in passage of the Ensuring Patient Access and Effective Drug Enforcement Act (EPAEDEA), which some criticized as hobbling DEA’s immediate suspension …

    • Litigation Briefing: HP&M Issues Report Summarizing Leading Cases and Settlements of 2017January 8th, 2018

      Hyman, Phelps & McNamara, P.C. is pleased to present this report summarizing leading cases and settlements from 2017 affecting the FDA-regulated industry. Our goal was to provide a concise summary of issues that most impact our clients, many of whom are drug and medical device …

    • What to Do When You Receive a DEA Order to Show CauseNovember 16th, 2017

      You may be a doctor, dentist, veterinarian, pharmacy, wholesale distributor, or manufacturer, and you just received an Order to Show Cause from the Drug Enforcement Administration (DEA). An Order to Show Cause can have a significant impact on your ability to handle controlled substances and, …