Policy & Compliance

Expert Analysis

• High Court's Hikma Decision Reshapes 'Skinny Label' Suits

  

  The U.S. Supreme Court's decision in Hikma v. Amarin marks a significant victory for generic drug manufacturers, but rather than putting an end to so-called skinny label inducement claims, it narrows and refocuses them, say attorneys at Sterne Kessler.

• Turning To The Courts When PBM Reform Falls Short

  

  The effectiveness of state laws intended to regulate pharmacy benefit managers remains uncertain, but litigation — utilizing tried-and-true theories like breach of contract and fair dealing — offers another mechanism through which stakeholders may seek relief from PBMs, say attorneys at Reed Smith.

• High Court's Abortion Pill Stay Reinforces Appellate Principles

  

  The U.S. Supreme Court's recent order in Danco Laboratories v. Louisiana, staying a Fifth Circuit ruling that reinstated an in-person requirement for dispensing the abortion medicine mifepristone, should be seen not as a definitive ruling on reproductive rights, but as an affirmation of a more disciplined jurisdictional reality, says Daniel Nardo at Nardo & Associates.

• Bracing For Enforcers' Growing Focus On Behavioral Health

  

  While recent law enforcement scrutiny of the behavioral health industry has resulted in several settlements, indicating that more enforcement activity is on the way, organizations now have an opportunity to take proactive compliance measures, says Jeffrey Fitzgerald at Polsinelli.

• DOJ Activity Indicates Rising Antitrust Risk For Hospitals

  

  Two civil actions filed by the U.S. Department of Justice against New York-Presbyterian Hospital and OhioHealth, both alleging that the hospital systems used their market power to stifle competition, highlight the government's growing scrutiny of barriers to lower-cost insurance options, say attorneys at Freshfields.

• Engaging With FDA's New Complete Response Letter Policy

  

  A citizen petition filed with the U.S. Food and Drug Administration last month puts renewed focus on the agency's practice of releasing complete response letters in near real time, materially altering the context in which life sciences companies communicate with investors regarding regulatory developments, say attorneys at Debevoise.

• 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.

• 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.

• 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.

• 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.

• 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.

• Health Cos. Must Act Quickly To Secure Digital Front Doors

  

  A fast-approaching deadline will require health providers to implement digital accessibility standards to their websites, necessitating important compliance steps that will help to ensure equal access to online health services, say attorneys at Holland & Knight.

• How Oregon Ruling Affects Federal Gender Care Crackdown

  

  In a favorable development for healthcare providers, an Oregon federal court recently vacated certain U.S. Department of Health and Human Services restrictions on gender-affirming care for minors, but the government's broader campaign against this care, including proposed rulemaking and agency investigations, leaves significant uncertainty, say attorneys at Arnold & Porter.