Policy & Compliance

Expert Analysis

• 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.

• NY Opioid Antagonist Mandate Leaves Employers Guessing

  

  A recently enacted New York law will require employers that are federally mandated to maintain first-aid supplies to now include an opioid antagonist, but being that it is subject to a complicated Occupational Safety and Health Administration analysis, employers face several unanswered compliance questions, say attorneys at Conn Maciel.

• Calif. Case Raises Questions For Medical Practice Investors

  

  The California attorney general's amicus brief in Art Center v. WCE and the California Medical Association's response highlight how the California appeals court's ruling could significantly affect the structure and enforceability of succession arrangements in medical practice ownership, say attorneys at Ropes & Gray.

• Previewing FDA Preapproval Access In Psychedelics EO

  

  The second of two pathways for psychedelic drug access outlined in President Donald Trump's recent executive order constitutes an unprecedented expansion of the Right to Try Act, which could fundamentally alter the psychedelic access landscape while presenting significant regulatory, operational and legal challenges, say attorneys at Husch Blackwell.

• Previewing FDA National Priority Vouchers In Psychedelics EO

  

  President Donald Trump's recent executive order on psychedelic drug access represents a watershed moment in federal drug policy, but its significance lies in two distinct regulatory pathways, the first being the Commissioner's National Priority Vouchers, which offer a significant opportunity to compress U.S. Food and Drug Administration review, say Kimberly Chew at Husch Blackwell and Odette Hauke at Odette Alina.

• AG Watch: Texas Charts A Course On Investigative Authority

  

  The Texas Supreme Court's recent decision in Texas v. PFLAG affirmed, and arguably expanded, the Texas attorney general's civil investigative demand authority, providing a road map that other courts evaluating state attorney general CIDs may find instructive, amid a lack of precedent, say attorneys at Kelley Drye.