Expert Analysis

• Unpacking HHS' Opinion On Cell Therapy Refund Programs

  

  A recent advisory opinion from the U.S. Department of Health and Human Services, determining that a biopharma company's refund program for its cell therapy will not be penalized, indicates an encouraging willingness to engage, but the regulator's assumptions about the program's limited term warrant a closer look, says Mary Kohler at Kohler Health.

• Series

  Rock Climbing Makes Me A Better Lawyer

  

  Rock climbing requires problem-solving, focus, risk management and resilience, skills that are also invaluable assets in my role as a finance lawyer, says Mei Zhang at Haynes and Boone.

• What Chevron's End Means For How Congress Does Business

  

  The U.S. Supreme Court’s recent Loper Bright Enterprises v. Raimondo decision, overturning the Chevron doctrine, will have a far-reaching impact across the entire public policy life cycle, beginning with how Congress writes its laws and extending through agency implantation and judicial review, say attorneys at K&L Gates.

• How 5 States' Deal Notification Laws Are Guiding Healthcare

  

  Healthcare transaction notification laws at various stages of implementation in California, Illinois, Indiana, Oregon and Washington are shaping sector mergers and acquisitions, with significant transparency, continuity of care and compliance implications as providers tackle complex regulatory requirements, says Melesa Freerks at DLA Piper.

• Think Like A Lawyer: Dance The Legal Standard Two-Step

  

  From rookie brief writers to Chief Justice John Roberts, lawyers should master the legal standard two-step — framing the governing standard at the outset, and clarifying why they meet that standard — which has benefits for both the drafter and reader, says Luke Andrews at Poole Huffman.

• Examining Chancery's Relaxed New Confidential Filing Rules

  

  The Delaware Court of Chancery’s overhauled Rule 5.1, which governs confidential filings, risks permitting nonconfidential information to be shielded from public review unless and until a challenge notice is filed — but several potential solutions could help to override this issue, says Delaware attorney Daniel J. McBride.

• Recent Settlement Shows 'China Initiative' Has Life After Death

  

  Though the U.S. Department of Justice shuttered its controversial China Initiative two years ago, its recent False Claims Act settlement with the Cleveland Clinic Foundation demonstrates that prosecutors are more than willing to civilly pursue research institutions whose employees were previously targeted, say attorneys at Benesch.

• How Orange Book Antitrust Scrutiny Is Intensifying

  

  Pharmaceutical patent holders should be reviewing Orange Book listing practices, as the Federal Trade Commission takes a more aggressive antitrust approach with actions such as the Teva listing probe, and the U.S. Food and Drug Administration calls attention to potentially improper listings, say attorneys at McDermott.

• What To Know As Children's Privacy Law Rapidly Evolves

  

  If your business hasn't been paying attention to growing state and federal efforts to protect children online, now is the time to start — there is no sign of this regulation slowing down, and more aggressive enforcement actions are to be expected in the coming year, says Susan Rohol at Willkie Farr.

• Opinion

  OFAC Sanctions Deserve To Be Challenged Post-Chevron

  

  The U.S. Supreme Court's Loper Bright decision opens the door to challenges against the Office of Foreign Assets Control's sanctions regime, the unintended consequences of which raise serious questions about the wisdom of what appears to be a scorched-earth approach, says Solomon Shinerock at Lewis Baach.

• Behind The Delay Of Final HSR Premerger Filing Rules

  

  Erin Toomey at Epiq discusses the wait for the final version of the revised Hart-Scott-Rodino premerger filing requirements that were first introduced in June 2023, the factors that might be behind the delay, and how to plan for the potential data-focused rule change

• What Cos. Should Know About New Global Plastics Regs

  

  As the global regulatory landscape for plastics and recycling changes rapidly — with new policies coming into effect in California, at the federal level, in the European Union and at the United Nations — businesses that operate across jurisdictions must stay informed to remain compliant, mitigate legal risk and achieve stewardship goals, say attorneys at O'Melveny.

• How Calif. Ruling Alters Worker Arb. Agreement Enforcement

  

  The California Supreme Court’s recent ruling in Ramirez v. Charter Communications should caution employers that while workers’ arbitration agreements will no longer be deemed unenforceable based on their number of unconscionable provisions, they must still be fair and balanced, says Sander van der Heide at CDF Labor.

• Opinion

  After Jarkesy, IRS Must Course-Correct On Captive Insurance

  

  The U.S. Supreme Court’s recent Securities and Exchange Commission v. Jarkesy decision has profound implications for other agencies, including the IRS, which must stop ignoring due process and curtailing congressional intent in its policing of captive insurance arrangements, says Peter Dawson at the 831(b) Institute.

• Congress Quietly Amends FEPA: What Cos. Should Do Now

  

  Last week, Congress revised the Foreign Extortion Prevention Act — passed last year to criminalize demand-side foreign bribery — to address inconsistencies and better harmonize the law with the Foreign Corrupt Practices Act, and companies should review their compliance programs accordingly, say Mark Mendelsohn and Benjamin Klein at Paul Weiss.