Expert Analysis

• 4 Legislative Proposals Reflect Growing Scrutiny Of Pharma IP

  

  Bipartisan legislative momentum in Congress, including a recent package of bills targeting exclusivity strategies that delay generic and biosimilar competition, signals growing scrutiny of life sciences intellectual property strategies, so biologics companies and investors must pay attention to new strategic, compliance and litigation risks, says Olga Berson at Thompson Coburn.

• The Potential Efficiencies, Risks Of Folding PCAOB Into SEC

  

  Integrating the Public Company Accounting Oversight Board into the U.S. Securities and Exchange Commission offers the potential for regulatory efficiencies, as well as a more streamlined and consistent enforcement approach, but it also presents constitutional and operational uncertainties, say attorneys at Hilgers Graben.

• What To Watch For As High Court Mulls NRC's Powers

  

  If successful, Texas’ challenges to the U.S. Nuclear Regulatory Commission’s authority — recently heard by the U.S. Supreme Court and currently pending before a Texas federal court — may have serious adverse consequences for aspiring NRC licensees, including potential nuclear power plant operators, say attorneys at Haynes Boone.

• Series

  Adapting To Private Practice: From NY Fed To BigLaw

  

  While the move to private practice brings a learning curve, it also brings chances to learn new skills and grow your network, requiring a clear understanding of how your skills can complement and contribute to a firm's existing practice, and where you can add new value, says Meghann Donahue at Covington.

• Reviewing Trump Admin's Rapid Pro-Crypto Regulatory Pivot

  

  The digital asset industry has received a boost from the explicitly pro-crypto Trump administration, which in its first few months reversed Biden-era rules and installed industry proponents at regulatory agencies, marking one of the biggest regulatory about-faces by a government in recent memory, says Robert Appleton at Olshan Frome.

• 7 Considerations For Conducting Drug Clinical Trials Abroad

  

  With continuing cuts to U.S. Food and Drug Administration staffing motivating some pharmaceutical companies to consider developing drugs abroad, it's important to understand the additional risks and compliance requirements associated with conducting clinical studies in other countries, say attorneys at Morgan Lewis.

• Trump's 1st 100 Days Show That Employers Must Stay Nimble

  

  Despite the aggressive pace of the Trump administration, employers must stay abreast of developments, including changes in equal employment opportunity law, while balancing state law considerations where employment regulations are at odds with the evolving federal laws, says Susan Sholinsky at Epstein Becker.

• Cos. Face Enviro Justice Tug-Of-War Between States, Feds

  

  The second Trump administration's sweeping elimination of environmental justice policies, programs and funding, and targeting of state-level EJ initiatives, creates difficult questions for companies on how best to avoid friction with federal policy, navigate state compliance obligations and maintain important stakeholder relationships with communities, say attorneys at Arnold & Porter.

• Top 3 Litigation Finance Deal-Killers, And How To Avoid Them

  

  Like all transactions, litigation finance deals can sometimes collapse, but understanding the most common reasons for failure, including a lack of trust or a misunderstanding of deal terms, can help both parties avoid problems, say Rebecca Berrebi at Avenue 33 and Boris Ziser at Schulte Roth.

• A 2-Step System For Choosing A Digital Asset Reporting Path

  

  Under the Internal Revenue Service's new digital asset reporting regulation, each type of asset may have three potential reporting destinations, so a detailed testing framework can help to determine the appropriate path, says Keval Sonecha at Sonecha & Amlani.

• NEPA Repeal Could Slow Down Environmental Review

  

  As the Trump administration has rescinded the Council on Environmental Quality's long-standing National Environmental Policy Act regulations, projects that require NEPA review may be bogged down by significant regulatory uncertainty and litigation risks, potentially undermining the administration's intent to streamline the permitting process, say attorneys at Mayer Brown.

• Compliance Lessons From Warby Parker's HIPAA Fine

  

  The U.S. Department of Health and Human Services' civil money penalty against Warby Parker highlights the emerging challenges that consumer-facing brands encounter when expanding into healthcare-adjacent sectors, with Health Insurance Portability and Accountability Act compliance being a potential focus of regulatory attention, say attorneys at Saul Ewing.

• 5th Circ. Ruling Is Latest Signal Of Shaky Qui Tam Landscape

  

  In his recent concurring opinion in U.S. v. Peripheral Vascular Associates, a Fifth Circuit judge joined a growing list of jurists suggesting that the False Claims Act's whistleblower provisions are unconstitutional, underscoring that acceptance of qui tam relators can no longer be taken for granted, say attorneys at Miller & Chevalier.

• Foreign Countries Have Strong Foundation To Fill FCPA Void

  

  Though the U.S. has paused enforcement of the Foreign Corrupt Practices Act, liberal democracies across the globe are well equipped to reverse any setback in anti-corruption enforcement, potentially heightening prosecution risk for companies headquartered in the U.S., says Stephen Kohn at Kohn Kohn.

• How Attys Can Use A Therapy Model To Help Triggered Clients

  

  Attorneys can lean on key principles from a psychotherapeutic paradigm known as the "Internal Family Systems" model to help manage triggered clients and get settlement negotiations back on track, says Jennifer Gibbs at Zelle.