Expert Analysis

• The Road Ahead For Florida's Drug Importation Program

  

  Though the U.S. Food and Drug Administration approved Florida's drug importation program in January, a series of hurdles — including requisite buy-in from Canada — and potential legal challenges must be addressed before importation can begin, say attorneys at Ropes & Gray.

• Practical Steps For Navigating New Sanctions On Russia

  

  After the latest round of U.S. sanctions against Russia – the largest to date since the Ukraine war began – companies will need to continue to strengthen due diligence and compliance measures to navigate the related complexities, say James Min and Chelsea Ellis at Rimon.

• Opinion

  UK Whistleblowers Flock To The US For Good Reason

  

  The U.K. Serious Fraud Office director recently brought renewed attention to the differences between the U.K. and U.S. whistleblower regimes — differences that may make reporting to U.S. agencies a better and safer option for U.K. whistleblowers, and show why U.K. whistleblower laws need to be improved, say Benjamin Calitri and Kate Reeves at Kohn Kohn.

• Think Like A Lawyer: Forget Everything You Know About IRAC

  

  The mode of legal reasoning most students learn in law school, often called “Issue, Rule, Application, Conclusion,” or IRAC, erroneously frames analysis as a separate, discrete step, resulting in disorganized briefs and untold obfuscation — but the fix is pretty simple, says Luke Andrews at Poole Huffman.

• Valeant Ruling May Pave Way For Patent-Based FCA Suits

  

  The Ninth Circuit’s recent ruling in Silbersher v. Valeant marks a significant development in False Claims Act jurisprudence, opens new avenues for litigation and potentially raises the stakes for patent applicants who intend to do business with the government, say Joshua Robbins and Rick Taché at Buchalter.

• The Corporate Transparency Act Isn't Dead Yet

  

  After an Alabama federal court's ruling last week rendering the Corporate Transparency Act unconstitutional, changes to the law may ultimately be required, but ongoing compliance is still the best course of action for most, says George Singer at Holland & Hart.

• Employer Pointers As Wage And Hour AI Risks Emerge

  

  Following the Biden administration's executive order on artificial intelligence, employers using or considering artificial intelligence tools should carefully assess whether such use could increase their exposure to liability under federal and state wage and hour laws, and be wary of algorithmic discrimination, bias and inaccurate or incomplete reporting, say attorneys at ArentFox Schiff.

• How New EU Tax And Transfer Pricing Rules May Affect M&A

  

  Companies involved in mergers and acquisitions may need to adjust fiscal due diligence procedures to ensure they consider potential far-reaching effects of newly implemented transfer pricing measures, such as newly implemented global minimum tax and European Union anti-tax avoidance directives and proposals, says Patrick Tijhuis at BDO.

• Employers, Prep For Shorter Stock Awards Settlement Cycle

  

  Companies that provide equity compensation in the form of publicly traded stock will soon have one less day to complete such transactions under U.S. Securities and Exchange Commission and Nasdaq rules — so employers should implement expedited equity compensation stock settlement and payroll tax deposit procedures now, say attorneys at Morgan Lewis.

• Complying With Enforcers' Ephemeral Messaging Guidance

  

  Given federal antitrust enforcers’ recently issued guidance on ephemeral messaging applications, organizations must take a proactive approach to preserving short-lived communications — or risk criminal obstruction charges and civil discovery sanctions, say attorneys at Manatt.

• New FinCEN Guide Provides Useful BOI Context For Banks

  

  Financial institutions should review a new Financial Crimes Enforcement Network compliance guide for helpful details about how the agency's beneficial ownership information database should be used, though questions remain about the access rule and whether it will truly streamline bank borrowers' Corporate Transparency Act due diligence, says George Singer at Holland & Hart.

• What's New In FDA's Updated Data Monitoring Guidance

  

  The U.S. Food and Drug Administration's new guidance on the use of data monitoring committees in clinical trials is set to replace the agency's 2006 guidance on the topic, with notable updates including stronger language indicating a more stringent stance against financial conflicts of interest and adaptation to recent changes in DMC structure, say attorneys at Hogan Lovells.

• Opinion

  Suits Against Insulin Pricing Are Driven By Rebate Addiction

  

  A growing wave of lawsuits filed by states, cities and counties against insulin manufacturers and pharmacy benefit managers improperly allocate the blame for rising insulin costs, when in actuality the plaintiffs are partially responsible, says Dan Leonard at Granite Capitol Consulting.

• Conn. Data Privacy Enforcement Takeaways For Cos.

  

  In light of the Connecticut attorney general's recently released report on its enforcement of the Connecticut Data Privacy Act, which focuses on companies' privacy policies, protections of sensitive data and more, businesses can expect increased enforcement scrutiny — especially in areas that are the subject of consumer complaints, say Paul Pittman and Abdul Hafiz at White & Case.

• Lessons For D&O Policyholders From Pharma Co. Ruling

  

  A California federal court's recent decision in AmTrust v. 180 Life Sciences, requiring insurers to advance defense costs for a potentially covered claim, provides a valuable road map for directors and officers insurance policyholders, rebutting the common presumption that a D&O insurer's duty to advance costs is more limited than under other policies, say attorneys at Pasich.