Policy & Compliance

Expert Analysis

• Informal Announcements Are Reshaping FDA Regulations

  

  The U.S. Food and Drug Administration's recent shift toward using press releases, podcasts and other informal channels to announce major policy changes reflects a valid desire to modernize and accelerate regulatory efforts, but it could lead to diminished transparency, increased industry burden and reduced policy durability, says Rachel Turow at Skadden.

• A Shift In Fed. Circ.'s Approach To Patent Summary Judgment

  

  The Federal Circuit's recent decision in Range of Motion v. Armaid may come to be seen as a seminal opinion for potentially exposing and entrenching the Federal Circuit's movement away from its previous framework for identifying obvious noninfringement cases, says Nicholas Nowak at Nowak IP Group.

• DOJ Actions Suggest Expansion Of Healthcare Enforcement

  

  Recent actions by the U.S. Department of Justice and U.S. Food and Drug Administration suggest that federal healthcare enforcement efforts are moving away from traditional program-based fraud and toward cases centered on product integrity, regulatory transparency and telehealth marketing, effectively widening the government's enforcement playbook, say attorneys at MoFo.

• 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.

• 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.

• 7 Steps For Gov't Contractors In Post-IEEPA Tariff Landscape

  

  In response to U.S. Supreme Court's recent decision to strike down tariffs issued by the Trump administration under the International Emergency Economic Powers Act, there are several actions federal contractors should take to preserve their place in any refund waterfall, and to manage audit, overpayment and False Claims Act risk, say attorneys at Holland & Knight.

• 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.

• 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.

• 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.