Expert Analysis

• Trump's Psychedelics EO Creates A Regulatory Collision

  

  Sponsors pursuing U.S. Food and Drug Administration approval for psychedelic drug access must tackle how to generate regulatory-grade safety and efficacy data in controlled trials when President Donald Trump's recent executive order on psychedelics mandates uncontrolled access through Right to Try, say Kimberly Chew at Husch Blackwell and Odette Hauke at Odette Alina.

• Becoming The Biz-Savvy GC That Portfolio Companies Need

  

  Candidates for general counsel roles at private equity-backed portfolio companies should prioritize proving their sector-specific experience, commercial judgment and ease with uncertainty — and attorneys hoping to be candidates in five to 10 years should start working on those skills now, says Dimitri Mastrocola at Major Lindsey.

• AI Regulatory Gaps May Fuel FCA Enforcement Action

  

  The intersection of artificial intelligence and False Claims Act enforcement presents legal risk for government contractors across several industries, particularly in the absence of a federal regulatory framework explicitly governing its development and use, say attorneys at O’Melveny.

• Series

  Judges On AI: How Courts Can Survive The Tech Revolution

  

  Colorado Supreme Court Justice Maria Berkenkotter and Colorado Court of Appeals Judge Lino Lipinsky de Orlov discuss how artificial intelligence has already fundamentally altered the legal system and offer tips for courts navigating deepfakes, hallucinations and a gap in access to AI tools.

• 'Skinny Label' Arguments Spotlight Induced Infringement Risk

  

  Recent oral arguments before the U.S. Supreme Court in Hikma Pharmaceuticals v. Amarin Pharma highlight the uncertain boundary between lawful generic competition through so-called skinny labels and induced patent infringement, with potential implications for patent holders’ communication, enforcement and causation strategies across industries, says Anton Hopen at Trenam.

• 3 AI Adoption Mistakes GCs Should Avoid

  

  The pressure in-house legal teams face to quickly adopt artificial intelligence tools, combined with budget constraints and the need to evaluate a crowded market of options, sets the stage for implementation mistakes that are often difficult to undo, says former 23andMe general counsel Guy Chayoun.

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  Playing Basketball Makes Me A Better Lawyer

  

  My grandfather used to say "I wear your jersey" as shorthand for wholly committing to support someone with loyalty and integrity — ideals that have shaped my life on the basketball court and in legal practice, says Tracy Schimelfenig at Schimelfenig Legal.

• EPA Listing Signals New Scrutiny Of Drugs In Drinking Water

  

  The recent publication of the U.S. Environmental Protection Agency's latest draft drinking water contaminant list highlights pharmaceuticals as a category of concern, marking the start of a process that could shape future research priorities, monitoring requirements, and federal and state actions, say attorneys at Morgan Lewis.

• Opinion

  5th Circ.'s Abortion Pill Order Is Shaky On Multiple Grounds

  

  The Fifth Circuit's recent order in Louisiana v. U.S. Food and Drug Administration, reinstating an in-person dispensing requirement for the abortion medication mifepristone, seems to turn federalism upside-down, and is also questionable for several other reasons, says Gregory Curtner at Curtner Law.

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  The Biz Court Digest: Georgia Court Has Business On Its Mind

  

  Thanks to recent legislation, the Georgia State-wide Business Court will soon offer business litigants greater access to the court than ever before, further enhancing the court's emphasis on efficiency, predictability and accessibility for sophisticated commercial disputes, says former GSBC judge Walt Davis at Jones Day.

• 5 Takeaways From Justices' Subpoena Fight Ruling

  

  The U.S. Supreme Court's recent decision in First Choice v. Davenport fortifies a line of First Amendment associational privacy cases stretching back nearly 70 years, and ensures that organizations subject to government demands for donor information have a meaningful federal forum in which to defend their constitutional rights, say attorneys at DLA Piper.

• Mass. Draft Regs Signal Nationwide Scrutiny Of Junk Fees

  

  Massachusetts Attorney General Andrea Campbell's new draft regulations for assisted living facilities is only her latest move in the war on junk fees — and part of a national reordering of consumer protection enforcement in which states are aggressively and creatively asserting authority, says Steve Provazza at Arnall Golden.

• 4 Emerging Approaches To AI Protective Order Language

  

  Over the last year, at least five federal district courts have issued or analyzed specific protective order provisions restricting the use of generative artificial intelligence platforms with protected materials, establishing that proactive AI-specific provisions are now standard practice and demonstrating that no single model works for every case, says Joel Bush at Kilpatrick.

• What Justices Are Focusing On In 'Skinny Label' Patent Case

  

  Though Hikma v. Amarin appears to be a patent dispute that could reshape inducement doctrine in the pharmaceutical context, oral argument suggests the U.S. Supreme Court may treat this as primarily a pleading-stage dispute, with important unresolved questions lurking beneath the surface, says Shashank Upadhye at Upadhye Tang.

• Accelerated Psychedelic Therapy Pathways Require Caution

  

  President Donald Trump's new executive order aiming to accelerate the approval of psychedelic drugs for the treatment of mental health disorders will likely bolster investigational psychedelic therapies, but parties within the psychedelic product supply chain will still need to prepare for potentially burdensome compliance requirements, say attorneys at Morgan Lewis.