Expert Analysis

• Pros And Cons Of FDA's Push For Nonprescription Drugs

  

  The U.S. Food and Drug Administration's recent moves to shift more prescription drugs to over-the-counter status could increase access to important medications, but also bring potential safety risks and other trade-offs for drug companies, say attorneys at Hogan Lovells.

• Prepping For The Future Of No Surprises Act Enforcement

  

  This year is expected to be a transition point for the No Surprises Act framework from regulatory delay to operational enforcement, so stakeholders should use this time to stress-test systems, clean up processes and prepare for enforcement, say attorneys at Akerman.

• High Court's 'Skinny Label' Case May Tackle Wider Questions

  

  The U.S. Supreme Court's upcoming decision in Hikma v. Amarin will have important ramifications for broader debates over what defines a generic version of a drug, and the pending case is already altering patent practice, say attorneys at Taft.

• Aligning Microsoft Tools With NYC Bar AI Recording Guidance

  

  The New York City Bar Association’s recently issued formal opinion, providing ethical guidance on artificial intelligence-assisted recording, transcription and summarization, raises immediate questions about data governance and e-discovery for companies that use Microsoft 365 and Copilot, say Staci Kaliner, Martin Tully and John Collins at Redgrave.

• Class Actions At The Circuit Courts: March Lessons

  

  In this month's review of class action appeals, Mitchell Engel at Shook Hardy discusses four recent rulings from January and identifies practice tips from cases involving allegations of violations of consumer fraud regulations, the Fair Credit Reporting Act, employment law and breach of contract statutes.

• FDA's Biosimilarity Guidance Holds Uncertain Implications

  

  The U.S. Food and Drug Administration's new draft guidance aimed at simplifying the biosimilarity demonstration process may not be enough to overcome the barriers that have historically constrained biosimilar competition, and could affect biosimilar access in unexpected ways, say analysts at Analysis Group.

• Unpacking Key Themes From NY's New Healthcare Strategy

  

  New York Gov. Kathy Hochul's 2026 State of the State agenda, read together with the state's fiscal year 2027 executive budget, reflect a clear framework to utilize Medicaid as the state's operating platform for healthcare reform, say attorneys at Sheppard.

• 5 Different AI Systems Raise Distinct Privilege Issues

  

  A New York federal court’s recent U.S. v. Heppner decision, holding that a defendant’s use of Claude was not privileged, only addressed one narrow artificial intelligence system, but lawyers must recognize that the spectrum of AI tools raises different confidentiality and privilege questions, says Heidi Nadel at HP.

• Health Co.'s 'Success Story' Misstep Holds HIPAA Lessons

  

  Cadia Healthcare Facilities' fall settlement with the U.S. Department of Health and Human Services for improperly disclosing patients' protected health information in online success stories is an instructive example of Health Insurance Portability and Accountability Act risks that can arise from digital marketing efforts, say attorneys at Woods Rogers.

• Opinion

  AI-Assisted Arbitration Needs Safeguards To Ensure Fairness

  

  As tribunals and arbitral institutions increasingly use artificial intelligence tools in their decision-making processes, ​​​​​​​clear disclosure standards and procedural safeguards are necessary to ensure that efficiency gains do not erode the fairness principles on which arbitration depends, says Alexander Lima at Wesco International.

• Trans Care Enforcement Landscape Is Evolving Quickly

  

  The recent coordinated federal effort to reshape pediatric gender-affirming care through enforcement and funding pressure has created a rapidly evolving regulatory environment marked by shifting risk assessments and potential downstream market effects for healthcare institutions and life sciences companies, say attorneys at Arnall Golden.

• Series

  Playing Piano Makes Me A Better Lawyer

  

  Playing piano and practicing law share many parallels relating to managing complexity: Just as hearing an entire musical passage in my head allows me to reliably deliver the message, thinking about the audience's impression helps me create a legal narrative that keeps the reader engaged, says Michael Shepherd at Fish & Richardson.

• 11th Circ. May Bring Tectonic Shift To FCA Qui Tam Actions

  

  The Eleventh Circuit's upcoming decision in Zafirov v. Florida Medical Associates, assessing whether the False Claims Act permits ordinary citizens to stand as officers of the federal government, could significantly limit private relators' ability to bring FCA actions, say attorneys at Saul Ewing.

• AI-Generated Doc Ruling Guides Attys On Privilege Risks

  

  A New York federal court's ruling, in U.S. v. Heppner, that documents created by a defendant using an artificial intelligence tool were not privileged, can serve as a guide to attorneys for retaining attorney-client or work-product privilege over client documents created with AI, say attorneys at Sher Tremonte.

• To Survive FCA Actions, Small Cos. Must Take Offensive Steps

  

  A fumbled response to False Claims Act allegations can doom lower-middle-market businesses, and with FCA enforcement hitting record levels for two years, smaller companies must have offensive strategies ready that focus their limited resources on defeating civil qui tam and federal criminal actions, says Derrelle Janey at Olshan Frome.