Expert Analysis

• FDA's Drug Software Draft Guidance Raises New Questions

  

  The U.S. Food and Drug Administration's long-awaited draft guidance regarding regulatory considerations for prescription drug use-related software functions as an informative starting point for developers, but many new and lingering questions must be answered before the regulatory limbo is resolved, say attorneys at King & Spalding.

• Series

  ESG Around The World: European Union

  

  As the EU makes ESG regulation a priority, companies — both those based in the EU and others just doing business there — need to keep abreast of myriad new legislation that has either already taken effect or will in the near future, as noncompliance could result in fines, damages and director liability, say attorneys at Steptoe & Johnson.

• Avoiding The Ethical Pitfalls Of Crowdfunded Legal Fees

  

  The crowdfunding of legal fees has become increasingly common, providing a new way for people to afford legal services, but attorneys who accept crowdsourced funds must remember several key ethical obligations to mitigate their risks, say Hilary Gerzhoy and Julienne Pasichow at HWG.

• 4 Pharma Industry Arguments Against CMS Drug Pricing Plan

  

  The Centers for Medicare & Medicaid Services is facing significant pushback regarding its plans for implementing the Inflation Reduction Act's Medicare drug price negotiation program, due to a number of potential repercussions for manufacturers, say attorneys at Mintz Levin.

• Issues Ahead As Psychedelic Medicine Faces Pivotal Moment

  

  Recent regulatory changes and decriminalization efforts have opened doors for research and development in psychedelic medicine, but challenges like stigma, access and funding persist, meaning companies will need to address these issues to support the industry’s credibility, say consultants at FTI Consulting.

• Bracing For Regulatory Delays As Shutdown Looms

  

  As a government shutdown looms, stakeholders should plan for regulatory delays and note that more regulations could become vulnerable to congressional disapproval under the Congressional Review Act, say Matthew Shapanka and Holly Fechner at Covington.

• An Overview Of 6 PBM Bills Moving Through Congress

  

  As legislators turn to pharmacy benefit manager reform as a potential next step in addressing the cost of prescription drugs, six congressional committees have recently advanced PBM-related legislation with generally high bipartisan support, suggesting that a final package is likely to advance through Congress, say Rachel Stauffer and Katie Waldo at McDermott+Consulting.

• 10th Circ. ERISA Ruling Is Promising For Self-Funded Plans

  

  Though some recent appellate decisions have seemingly narrowed application of Employee Retirement Income Security Act preemption, which generally helps protect self-funded health plans from state regulation, the Tenth Circuit's decision in PCMA v. Mulready takes a big step toward reaffirming preemption, say attorneys at Bass Berry.

• What Large Language Models Mean For Document Review

  

  Courts often subject parties using technology assisted review to greater scrutiny than parties conducting linear, manual document review, so parties using large language models for document review should expect even more attention, along with a corresponding need for quality control and validation, say attorneys at Sidley.

• Checking In On How SuperValu Has Altered FCA Litigation

  

  Four months after the U.S. Supreme Court's ruling in U.S. ex rel. Chutte v. SuperValu, the decision's reach may be more limited than initially anticipated, with the expansion of the scienter standard counterbalanced by some potential defense tools for defendants, say Elena Quattrone and Olivia Plinio at Epstein Becker.

• Participating In Living History Makes Me A Better Lawyer

  

  My role as a baron in a living history group, and my work as volunteer corporate counsel for a book series fan association, has provided me several opportunities to practice in unexpected areas of law — opening doors to experiences that have nurtured invaluable personal and professional skills, says Matthew Parker at the Nebraska Department of Health and Human Services.

• How A Gov't Shutdown Would Affect Immigration Processing

  

  While a government shutdown would certainly create issues and cause delays for immigration processing, independently funded functions would continue for at least a limited time, and immigration practitioners can expect agencies to create reasonable exceptions and provide guidance for navigating affected matters once operations resume, say William Stock and Sarah Holler at Klasko Immigration Law Partners.

• Opinion

  Smart Immigration Reform Can Improve Health Care Access

  

  With the U.S. health care crisis expected to worsen due to ongoing nationwide physician shortages, immigration reform can provide one short-term solution to bring more trained doctors to medically underserved areas, says Sarah Peterson at Fragomen.

• Opinion

  Private Equity Owners Can Remedy Law Firms' Agency Issues

  

  Nonlawyer, private-equity ownership of law firms can benefit shareholders and others vulnerable to governance issues such as disparate interests, and can in turn help resolve agency problems, says Michael Di Gennaro at The Law Practice Exchange.

• Cos. Must Overhaul Data Privacy Approach To Avoid Lawsuits

  

  With the proliferation of third-party trackers and the increasing complexity of privacy laws, companies need to significantly change their approach to online privacy to avoid litigation by focusing on responsible data collection practices and ongoing monitoring of ad tech tools, says Ian Cohen at LOKKER.