Expert Analysis

• New Pharma Guidelines Bring Pitfalls For Compounders

  

  New guidelines from U.S. Pharmacopeia, which went into effect last month, require some extensive and potentially expensive compliance efforts from hospitals and compounding pharmacies, and smaller compounders could particularly struggle, says Natalia Mazina at Mazina Law.

• The State Of CFPB Focus On Credit Reporting Of Medical Debt

  

  An increase in credit reporting complaints and the Consumer Financial Protection Bureau's recent annual report on the Fair Debt Collection Practices Act — which focuses on medical debt in credit reporting — are both evidence of the fact that the bureau will continue to prioritize oversight of credit reporting of medical debt, says Kristen Watson at Burr & Forman.

• Opinion

  What Happens If High Court Rejects Releases In Purdue Ch. 11

  

  Reading the tea leaves following the U.S. Supreme Court's recent arguments in Harrington v. Purdue Pharma, it appears likely that the justices will decide that bankruptcy courts lack the power to release third-party claims against nondebtors, which would result in one of three scenarios, says Gregory Germain at Syracuse University.

• FDA's Recent Litigation Records Are Strong, But Imperfect

  

  The U.S. Food and Drug Administration has notched its share of litigation wins in recent years thanks to a number of key advantages, but the FDA has been less successful in certain highly visible arenas, Jonathan Berman and Colleen Heisey at Jones Day.

• 5 Steps For Healthcare Companies After Biden's AI Order

  

  Rather than simply monitoring for the issuance of agency guidelines on artificial intelligence in the wake of President Joe Biden's October executive order, health and life sciences companies should take action now and begin building internal operational and technical infrastructures designed to govern the use of AI, says Joy Sharp at Faegre Drinker.

• Opinion

  Giving The Gov't Drug Patent March-In Authority Is Bad Policy

  

  The Biden administration's recent proposal to allow government seizure of certain taxpayer-funded drug patents is a terrible idea that would negate the benefits of government-funded research, to the detriment of patients and the wider economy, says Wayne Winegarden at Pacific Research Institute.

• How Clients May Use AI To Monitor Attorneys

  Excerpt from Practical Guidance

  

  Artificial intelligence tools will increasingly enable clients to monitor and evaluate their counsel’s activities, so attorneys must clearly define the terms of engagement and likewise take advantage of the efficiencies offered by AI, says Ronald Levine at Herrick Feinstein.

• When Patients Have Standing For Hospital Antitrust Suits

  

  Brown v. Hartford Healthcare Corp., recently decided by a Connecticut state court, provides a useful examination of how antitrust standing issues may be analyzed when patients directly sue a healthcare system for anti-competitive conduct, says Charles Honart at Stevens & Lee.

• How AI Executive Order Aims To Compete For Foreign Talent

  

  Immigration provisions within the Biden administration's executive order on artificial intelligence take a strategic approach to promoting the U.S. as a destination for AI and STEM talent by streamlining visa processing, enhancing educational and exchange programs, and improving current visa programs and pathways to permanent residency, says Eric Bord at Morgan Lewis.

• Series

  ESG Around The World: Singapore

  

  Singapore is keen to establish itself as a leading international financial center and a key player in the sustainable finance ecosystem, and key initiatives led by its government and other regulatory bodies have helped the Asian nation progress from its initially guarded attitude toward ESG investment and reporting, say attorneys at Morgan Lewis.

• Series

  The Pop Culture Docket: Judge D'Emic On Moby Grape

  

  The 1968 Moby Grape song "Murder in My Heart for the Judge" tells the tale of a fictional defendant treated with scorn by the judge, illustrating how much the legal system has evolved in the past 50 years, largely due to problem-solving courts and the principles of procedural justice, says Kings County Supreme Court Administrative Judge Matthew D'Emic.

• Navigating Asset Tracing Challenges In Bankruptcy

  

  A Virginia court’s recent ruling in Health Diagnostic Laboratory Inc.'s bankruptcy highlights the heightened demand for asset tracing and the strategic use of the lowest intermediate balance rule in recovering funds from commingled accounts, says Daniel Lowenthal at Patterson Belknap.

• Reading The Fine Print On FDA's Prescription Drug Ad Rule

  

  The U.S. Food and Drug Administration's new final rule regarding the disclosure of risks and side effects in ads for prescription drugs includes some broad and potentially subjective language, and some missed opportunities to address how traditional media formats have changed in recent years, say attorneys at Ropes & Gray.

• The Basics Of Law Firm Cyber Liability Insurance Applications

  

  Cyber liability insurance has become a common consideration for law firms as cyber threats have escalated, but these insurance forms can be quite complicated given the nature of the industry and associated risks, so simply filling out the form won't necessarily result in an ideal policy for your firm, says Kevin Haight at WAMS.

• Insurance Considerations For Cos. Assessing New AI Risks

  

  Because no two businesses will have the same artificial intelligence risk profile, they should consider four broad risk categories as a baseline for taking a proactive approach to guarding against AI-related exposures, say attorneys at Hunton.