Policy & Compliance

Expert Analysis

• 10 Practical Takeaways From FDA's Biopharma AI Guidance

  

  Recent guidance from the U.S. Food and Drug Administration provides much-needed insight on the usage of artificial intelligence in producing information to support regulatory decision-making regarding drug safety, with implications ranging from life cycle maintenance to AI tool acquisition, say attorneys at Covington.

• Lawmakers Shouldn't Overlook Rare Disease Therapies' Value

  

  As the ORPHAN Cures Act is pending in Congress, policymakers assessing the value of certain drugs for price regulation should consider data beyond what is collected in clinical trials, say Alice Chen at the University of Southern California, and Molly Frean and Yao Lu at Analysis Group.

• What Trump's Order Means For The Legal Status Of IVF

  

  An executive order signed by President Donald Trump last month signals the administration's potential intention to increase protections for in vitro fertilization services, though more concrete actions would be needed to resolve the current uncertainty around IVF access or bring about a binding legal change, says Jeanne Vance at Weintraub Tobin.

• Mitigating Tariff Risks For Healthcare In US And Canada

  

  Healthcare stakeholders should take steps to evaluate the impact of cross-border tariffs, as the historically strong ties between Canada and the U.S. demonstrate the potential for real disruption and harm to the healthcare industry in both countries, say attorneys at Norton Rose.

• What's At Stake In High Court Transgender Care Suit

  

  The outcome of U.S. v. Skrmetti will have critical implications for the rights of transgender youth and their access to gender-affirming care, and will likely affect other areas of law and policy involving transgender individuals, including education, employment, healthcare and civil rights, say attorneys at ArentFox Schiff.

• 6 Laws Transforming Calif.'s Health Regulatory Framework

  

  Attorneys at Hooper Lundy discuss a number of new California laws that raise pressing issues for independent physicians and small practice groups, ranging from the use of artificial intelligence to wage standards for healthcare employees.

• Anticipating Calif. Oversight Of PE Participation In Healthcare

  

  A new bill recently introduced in the California Senate revives last year's attempt to increase oversight of healthcare transactions involving private equity groups and hedge funds, meaning that attorneys may soon need to assess the compliance status of existing management relationships and consider modifying contract terms, says Andrew Demetriou at Husch Blackwell.

• Considering The Future Of AI Regulation On Health Sector

  

  As Texas looks to become the next state to pass a comprehensive law regulating artificial intelligence, the healthcare industry should consider how AI regulation will continue to evolve in the U.S. and how industry members can keep up with compliance considerations, say attorneys at Kirkland & Ellis.

• What To Expect From 'Make America Healthy Again' Actions

  

  The Make America Healthy Again Commission recently established by President Donald Trump and chaired by Robert F. Kennedy Jr. will potentially bring energy and attention to important public health topics, and stakeholders should be aware of pathways for sharing their input and proactively informing proceedings, says Nicholas Manetto at Faegre Drinker.

• How Citizen Petitions Have Affected Drug Competition

  

  In light of recent citizen petitions and proposed legislation regulating such petitions, Omar Robles at Managing Health analyzes the statistics of the extent to which citizen petitions have been filed, and to what extent they have delayed competition in prescription pharmaceuticals.

• Drug Kickback Ruling Will Make FCA Liability Harder To Prove

  

  The First Circuit's ruling in U.S. v. Regeneron Pharmaceuticals, requiring the government to prove but-for causation to establish False Claims Act liability based on violations of the Anti-Kickback Statute, raises the bar for FCA enforcement and deepens a circuit split that the U.S. Supreme Court may need to resolve, say attorneys at Baker Donelson.

• Assessing PE Risk After Mass. False Claims Act Amendments

  

  A law recently passed in Massachusetts amends the commonwealth's False Claims Act by dramatically expanding potential liability for private equity firms and investors, underscoring the importance of robust diligence and risk assessments for private equity firms conducting transactions in the commonwealth, say attorneys at Gibson Dunn.

• What Trump Actions Mean For Federal Research Funding

  

  New guidance from the National Institutes of Health represents a massive policy shift regarding federal funding for researchers at institutions of higher education, contributing to a perfect storm of significant resource shortfalls in upcoming years, say attorneys at Arnold & Porter.