Expert Analysis

• A Meaningful Shift In FDA's Biosimilarity Analysis

  

  The U.S. Food and Drug Administration's potential pivot away from routinely requiring comparative efficacy studies for interchangeable biosimilar applications would not lower regulatory standards, but instead allow applicants to allocate resources toward establishing more probative evidence, says Theodore Thompson at Stinson.

• Top 5 Antitrust Issues For In-House Counsel To Watch In 2026

  

  With Trump administration enforcement policy having largely taken shape last year, antitrust issues that in-house counsel should have on the radar range from scrutiny of technology-assisted pricing to the return of merger remedies, say attorneys at Squire Patton.

• 2025 Legal Milestones That Will Shape Psychedelics Sector

  

  As 2025 draws to a close, psychedelic drug development stands at an inflection point, experiencing unprecedented momentum through recent sweeping regulatory changes and landmark clinical milestones, amid rapidly evolving regulatory expectations, say Odette Hauke at Odette Alina LLC and Kimberly Chew at Husch Blackwell.

• 2025 State AI Laws Expand Liability, Raise Insurance Risks

  

  As 2025 nears its end, claims professionals should be aware of trends in state legislation addressing artificial intelligence use, as insurance claims based on some of these liability-expanding statutes are a certainty, say attorneys at Wiley.

• Learning From 2025 FCA Trends Targeting PE In Healthcare

  

  False Claims Act enforcement trends and legislative developments from this year signal intensifying state and federal scrutiny of private equity's growing footprint in healthcare, and the urgency of compliance, says Lisa Re at Arnold & Porter.

• How 11th Circ.'s Qui Tam Review Could Affect FCA Litigation

  

  On Dec. 12, the Eleventh Circuit will hear arguments in U.S. ex rel. Zafirov v. Florida Medical Associates, setting the stage for a decision that could drastically reduce enforcement under the False Claims Act, and presenting an opportunity to seek U.S. Supreme Court review of the act's whistleblower provisions, say attorneys at Epstein Becker.

• How MAHA Is Taking Shape At The State Level

  

  The national spotlight on the federal government's Make America Healthy Again movement is bolstering state-level actions regarding potential health impacts of certain food ingredients, increasing the difficulty and importance of maintaining effective compliance programs, say attorneys at Cooley.

• A Look At Middlemen Fees In 340B Drug Discount Program

  

  A U.S. Senate committee's recent hearing on the Section 340B drug discount program, along with statistical analysis of payment amounts, contribute to a growing consensus that middlemen fees are too high, say William Sarraille at the University of Maryland, and Shanyue Zeng and Rory Martin at IQVIA.

• Nursing Home Abuse Cases Face 3 Barriers That Need Reform

  

  Recent headlines reveal persistent gaps in oversight and protection for vulnerable residents in long-term care, but prosecution of these cases is often stymied by numerous challenges that will require a comprehensive overhaul of regulatory, legal and financial structures to address, says Veronica Finkelstein at Wilmington University.

• Mulling Differing Circuit Rulings On Gender-Affirming Care

  

  Despite the Eleventh Circuit's recent holding in Lange v. Houston County that a health plan's exclusion for gender-affirming surgery did not violate Title VII, employers should be mindful of other court decisions suggesting that different legal challenges may still apply to blanket exclusions for such care, say attorneys at Smith Gambrell.

• State AGs May Extend Their Reach To Nat'l Security Concerns

  

  Companies with foreign supply-chain risk exposure need a comprehensive risk-management strategy to address a growing trend in which state attorneys general use broadly written state laws to target conduct that may not violate federal regulations, but arguably constitutes a national security threat, say attorneys at Wiley.

• Unique Aspects Of Texas' Approach To AI Regulation

  

  The Texas Responsible AI Governance Act — which will soon be the sole comprehensive artificial intelligence law in the U.S. — pulls threads from EU and Colorado laws but introduces more targeted rules with fewer obligations on commercial entities, say attorneys at MVA Law.

• Surveying The Healthcare Policy Landscape Post-Shutdown

  

  With last week's agreement to reopen the federal government, at least through the end of January, key healthcare legislation that has been in limbo since a December 2024 spending bill fell apart may recapture the attention of Congress, say attorneys at Faegre Drinker.