Expert Analysis

• New Orphan Drug Law Provides A Key Fix For Pharma Cos.

  

  The Consolidated Appropriations Act enacted last month restores the U.S. Food and Drug Administration's long-standing interpretation of "same disease or condition," related to orphan drug exclusivity, resolving years of regulatory uncertainty and litigation that have discouraged rare disease research, say attorneys at Spencer Fane.

• FDA User Fee Talks Offer Clues On Upcoming Reforms

  

  As the U.S. Food and Drug Administration undergoes the User Fee Act reauthorization process and renegotiates its user fee agreements over the next several months, the agency's consultation meetings with relevant industries can shed light on the FDA's priorities, and provides stakeholders an opportunity to participate in the reform process, say attorneys at Holland & Knight.

• Changes Coming To The SBIR And STTR Programs

  

  Legislation recently approved by Congress to reauthorize the Small Business Innovation Research and Small Business Technology Transfer Programs includes changes focused on national security that would improve transparency but also increase applicants' administrative burdens, slow the awards process and likely increase litigation, say attorneys at Fluet & Associates.

• FDA Framework For Personalized Therapies Raises Questions

  

  The U.S. Food and Drug Administration's new plausible mechanism framework for developing individualized therapies reflects the agency's focus on rare-disease drugs, but numerous significant, unresolved issues cast uncertainty on how effective the framework will be in practice, say attorneys at Ropes & Gray.

• 5 Tips For Navigating Your Firm's All-Attorney Summit

  Excerpt from Practical Guidance

  

  Law firm retreats should be approached strategically, as they present valuable opportunities to advance both the firm's objectives and attorneys' professional development through meaningful participation, building and strengthening internal relationships, and proactive follow-up, says James Argionis at Cozen O’Connor.

• Scrutiny Of Nursing Home Practices Marks Inflection Point

  

  Recent congressional inquiries into UnitedHealth Group's Medicare Advantage-linked nursing home practices raise questions about whether financial metrics are allowed to influence decisions governed by the standard of care, and could implicate duties imposed by federal regulations, state negligence laws and elder abuse statutes, says Lindsey Gale at Rafferty Domnick.

• Series

  Coaching Soccer Makes Me A Better Lawyer

  

  Coaching youth soccer for my 7-year-old son's team has sharpened how I communicate with clients, prepare witnesses, work within teams and think about leadership, making me a more thoughtful and effective lawyer in many ways, says Joshua Holt at Smith Currie.

• Series

  Law School's Missed Lessons: The Human Element

  

  Law school teaches you to quickly apply intellect and logic when handling a legal issue, but every fact pattern also involves a person, making the ability to balance expertise with empathy critical to the growth of relationships with clients, colleagues and adversaries, says Rachel Adcox at Adcox Strategies.

• CMS Healthcare Enforcement Initiatives May Cause Disruption

  

  The Centers for Medicare & Medicaid Services' recently announced enforcement actions against healthcare fraud mark a significant escalation, and CMS' prior approach in the hospice sector suggests that even compliant providers and suppliers should brace for impact, say attorneys at Morgan Lewis.

• How Cos. Should Prepare For NY RAISE Act Compliance

  

  With the New York Responsible AI Safety and Education Act taking effect March 19, state regulators will expect subject artificial intelligence governance policies to understand whether appropriate safeguards and protocols are in place to prevent or mitigate discriminatory or adverse outcomes by frontier models, says Michael Paulino at Gordon Rees.

• What We Know About DOJ's New FCA Enforcement Priorities

  

  Recent remarks from the leader of the Justice Department’s commercial litigation branch provide key insights on how False Claims Act cases — especially healthcare fraud, trade fraud, antidiscrimination and cybersecurity claims — will be evaluated, prioritized and pursued as heightened enforcement becomes the new normal, say attorneys at Latham.

• The Benefits Of Choosing A Niche Practice In The AI Age

  

  As artificial intelligence becomes increasingly accessible, lawyers with a niche practice may stand out as clients seek specialized judgment that automation cannot replicate, but it is important to choose a niche that is durable, engaging and a good personal fit, says Daniel Borneman at Lowenstein Sandler.

• How PBMs Can Adapt To Plan Sponsors' Disclosure Demands

  

  As federal reforms, growing state regulation and litigation threats push plan sponsors to expect visibility into revenue streams, pharmacy benefit managers should leverage transparency strategically, including by simplifying how they get paid, offering clients audit-ready data and co-designing contracts that are easy for fiduciaries to explain and defend, says Kristie Blase at Frazer + Blase.

• How To Engage With Gov't's Direct-To-Consumer Drug Policy

  

  The U.S. Department of Health and Human Services' recent request for industry input on manufacturers' direct-to-consumer drug sales reflects the government's caution in this arena, and allows stakeholders a rare opportunity to help shape policy, says Mary Kohler at Kohler Health Law.

• Opinion

  It's Time To Clarify California's Elder Abuse Act

  

  As California's elderly population soars, the Golden State's high court and Legislature must provide needed clarification about the scope of the Elder Abuse Act, to resolve the inconsistencies and ambiguities that have impeded the law's ability to remedy elder abuse, neglect and abandonment, say attorneys at Horvitz & Levy.