Policy & Compliance

Expert Analysis

• 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  The U.S. Food and Drug Administration's latest draft guidance about accelerated drug approval indicates the FDA's intent to address the significant lag time between accelerated approval and full approval of drugs and may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.

• Top 10 Noncompete Developments Of 2024

  

  Following an eventful year in noncompete law at both state and federal levels, employers can no longer rely on a court's willingness to blue-pencil overbroad agreements and are proceeding at their own peril if they do not thoughtfully review and carefully enforce such agreements, say attorneys at Faegre Drinker.

• What 2024 Tells Us About Calif. Health Transaction Reviews

  

  Looking back at the California Office of Health Care Affordability's first year accepting notices for material healthcare transactions reveals critical lessons on what the OHCA's review process may mean for the future of covered transactions in the state, say attorneys at Ropes & Gray.

• Updated HIPAA Rule Is A Necessary Step For Data Protection

  

  The U.S. Department of Health and Human Services' updated rules addressing cybersecurity threats in healthcare will necessitate significant investment in technology, training and compliance infrastructure, but are an essential evolution in safeguarding data in an increasingly digital world, say attorneys at Clark Hill.

• Courts Must Curb The Drug Price Negotiation Program

  

  The Inflation Reduction Act's drug price negotiation program upends incentive structures that drive medical innovation, and courts must act appropriately to avoid devastating consequences for American healthcare and the pharmaceutical industry, says Jeff Stier at the Consumer Choice Center.

• The OIG Report: Preparing For Oversight In 2025

  

  Across sectors, Office of Inspector General work plans and challenge reports for 2025 provide a trove of information on the issues and industries that will likely be the focus of government oversight in the year to come, says Diana Shaw at Wiley.

• 5 Drug And Device Developments That Shaped 2024

  

  The last year saw significant legal developments affecting drug and device manufacturers, with landmark decisions and regulatory changes that require vigilance and agility from the industry, say attorneys at Faegre Drinker.

• How New Fraud Enforcement Tool Affects Gov't Contractors

  

  Government contractors will likely face greater scrutiny under the recently enacted Administrative False Claims Act, which broadens federal agencies' authority to pursue low-dollar fraud claims, but contractors may also find the act makes settlement of such claims easier to negotiate, say attorneys at Wiley.

• Consultants Should Be Aware Of DOJ's Potential New Reach

  

  The U.S. Department of Justice's recent first-of-its-kind settlement with McKinsey & Co. indicates not only the DOJ's more aggressive stance toward businesses' potential criminal wrongdoings, but also the benefits of self-disclosure and cooperation when wrongdoing becomes apparent, says Dom Caamano at Kibler Fowler.

• Health Tech Regulatory Trends To Watch In 2025

  

  With an upcoming change in administration and the release of some long-awaited rules, the healthcare industry should prepare for shifting trends, including a growing focus on health data and interest in technology-enabled delivery of healthcare, say attorneys at Orrick.