Policy & Compliance

Expert Analysis

• Drug Pricing Policy Trends To Expect In 2025 And Beyond

  

  Though 2025 may bring more of the same in the realm of drug pricing policy, business as usual entails a sustained, high level of legal and policy developments across at least six major areas, say attorneys at Ropes & Gray.

• Top 10 Healthcare And Life Sciences Issues To Watch In 2025

  

  Under the new Trump administration, this coming year may benefit some healthcare and life sciences stakeholders, while creating new challenges for others amid an increasingly complex regulatory environment, say attorneys at Debevoise.

• 4 Keys To Litigating In An Active Regulatory Environment

  

  For companies facing litigation influenced by government regulatory action — a recent trend that a politically charged atmosphere will exacerbate — there are a few principles that can help to align litigation strategy with broader public positioning in the regulatory and oversight context, say attorneys at Jenner & Block.

• How Views On Healthcare Price Transparency Are Changing

  

  Regulators' attitudes toward price transparency regulation have shifted over the past several years in ways that may seem contradictory, and research into detailed rate information published by hospitals and health plans has yielded mixed results, says Matthew List at Charles River Associates.

• EEOC Wearable Tech Guidance Highlights Monitoring Scrutiny

  

  The U.S. Equal Employment Opportunity Commission's recent fact sheet on wearable technologies cautions against potential issues with federal anti-discrimination laws and demonstrates growing concern from regulators and legislators about intrusive technologies in the workplace, say attorneys at Littler.

• Navigating The Potential End Of GLP-1 Drug Shortages

  

  The U.S. Food and Drug Administration's determination of whether GLP-1 products are in shortage may affect how compounders provide these products and spur a range of litigation including patent disputes and unfair competition suits, say attorneys at Goodwin.

• Politicized OIGs Could Target Federal Employees, Contractors

  

  After President Donald Trump fired nearly 20 inspectors general last week, it’s worth exploring how the administration could use Offices of Inspectors General to target federal employees and contractors, why it would be difficult to fight this effort, and one possible bulwark against the politicization of these watchdogs, says Sara Kropf at Kropf Moseley.

• Takeaways From DOJ Fraud Section's 2024 Year In Review

  

  Attorneys at Paul Weiss highlight notable developments in the U.S. Department of Justice Fraud Section’s recently released annual report, and discuss what the second Trump administration could mean for enforcement in the year to come.

• IVF Suits Highlight Need For Better Legal Frameworks

  

  The high number of in vitro fertilization embryo losses underscores the need for more cohesive legal and regulatory guidance related to human errors, property versus personhood, and liability, says Jeff Korek at Gersowitz Libo.

• Takeaways From FDA's Updated Confirmatory Trial Guidance

  

  The U.S. Food and Drug Administration's latest draft guidance about accelerated drug approval indicates the FDA's intent to address the significant lag time between accelerated approval and full approval of drugs and may help motivate the industry to complete confirmatory trials, say attorneys at Sheppard Mullin.

• A Look At FDA's Plans To Establish New OTC Drug Category

  

  The U.S. Food and Drug Administration's recently finalized rule, creating a new over-the-counter pathway for drugs when patients satisfy certain conditions, may be useful for off-patent drugs with established safety records, though switching to OTC comes with additional costs and considerations, say attorneys at Skadden.

• 2024 Was A Significant Year For HIPAA Compliance

  

  The Office of Civil Rights' high level of Health Insurance Portability and Accountability Act activity in 2024 and press releases about its specific focus on certain cybersecurity issues make it abundantly clear that the OCR is not going to tolerate widespread compliance complacency, says Nathan Kottkamp at Williams Mullen.

• How 2025 NDAA May Affect DOD Procurement Protests

  

  A bid protest pilot program included in the 2025 National Defense Authorization Act shifts litigation costs onto unsuccessful bid protesters and raises claim-filing thresholds, which could increase risks to U.S. Department of Defense contractors who file protests, and reduce oversight of DOD procurement awards, say attorneys at Venable.