Policy & Compliance

Expert Analysis

• How 11th Circ.'s Zafirov Decision Could Upend Qui Tam Cases

  

  Oral argument before the Eleventh Circuit last month in U.S. ex rel. Zafirov v. Florida Medical Associates suggests that the court may affirm a lower court's opinion that the qui tam provisions of the False Claims Act are unconstitutional — which could wreak havoc on pending and future qui tam cases, say attorneys at Morgan Lewis.

• Key Trends For Life Sciences Cos. To Watch In 2026

  

  Following a year of drastic change at the U.S. Food and Drug Administration, two themes are likely to drive the coming year — a commitment to lowering the cost of drugs and an inherent tension between the priorities of the health agencies and the broader administration, say attorneys at Sheppard Mullin.

• The Next Pressure Point In Digital Health: Informed Consent

  

  Two new federal digital health initiatives will usher in a new era where virtual care, software-enabled devices and home-based monitoring are integrated into care and reimbursement models, with the impact of shifting rules and opportunities felt most immediately in the context of informed consent, says Kimberly Chew at Husch Blackwell.

• 4 Trends Shaping Drug And Medical Device Law For 2026

  

  2025 saw some significant legal developments with potential impact for drug and device manufacturers, ranging from growing skepticism in science and regulatory entities to new regulation of artificial intelligence, say attorneys at Faegre Drinker.

• Preparing For Congressional Investigations In A Midterm Year

  

  2026 will be a consequential year for congressional oversight as the upcoming midterm elections may yield bolder investigations and more aggressive state attorneys general coalitions, so companies should consider adopting risk management measures to get ahead of potential changes, say attorneys at Morgan Lewis.

• 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.