Expert Analysis

• Questions Linger After FDA's Lab-Developed Tests Proposal

  

  The U.S. Food and Drug Administration's recently proposed rule regarding its plan to regulate lab-developed tests is light on details, leaving many fundamental questions about the agency's authority and ability to execute its plans, say attorneys at Covington.

• Lessons For Biosimilar And Biologic Antitrust Litigation

  

  Aaron Marks at Cohen Milstein considers emerging ways in which biosimilar markets differ from traditional small-molecule drug markets, and recommends how pharmaceutical antitrust litigators can account for these market dynamics in biosimilar-delay cases.

• Balancing Justice And Accountability In Opioid Bankruptcies

  

  As Rite Aid joins other pharmaceutical companies in pursuing bankruptcy following the onslaught of state and federal litigation related to the opioid epidemic, courts and the country will have to reconcile the ideals of economic justice and accountability against the U.S. Constitution’s promise of a fresh start through bankruptcy, says Monique Hayes at DGIM Law.

• How To Navigate The FTC's New Private Equity Frontier

  

  The Federal Trade Commission's recent district court complaint against an anesthesia firm and its private equity partner tests key bounds of the agency's stand-alone authority, and defense strategies can include challenges to both the geographic and the service market fronts, say attorneys at Baker McKenzie.

• Opinion

  Newman Suspension Shows Need For Judicial Reform

  

  The recent suspension of U.S. Circuit Judge Pauline Newman following her alleged refusal to participate in a disability inquiry reveals the need for judicial misconduct reforms to ensure that judges step down when they can no longer serve effectively, says Aliza Shatzman at The Legal Accountability Project.

• An Overview Of Congress' Proposed Drug Shortage Solutions

  

  Recently, Congress has seen a number of bipartisan bills that seek to prevent and respond to national drug shortages, though disagreements over the right vehicle and timeline have slowed progress, says Miranda Franco at Holland & Knight.

• Considerations And Calculations For DOJ Clawback Program

  

  The U.S. Department of Justice’s clawback pilot program announced earlier this year presents numerous questions for businesses, and both hypothetical and recent real-world examples capture how companies’ cost-benefit analyses about whether to claw back compensation in exchange for penalty reductions may differ, say Yogesh Bahl and Jonathan Hecht at Resolution Economics.

• SEC's Life Sciences Actions Utilize Novel Tools And Theories

  

  Recent enforcement actions show that the U.S. Securities and Exchange Commission is employing new forms of data analytics and noteworthy applications of insider trading laws in its scrutiny of fraud within the life sciences and health industries, say Edward Imperatore and Jina Choi at MoFo.

• What Case Trends Reveal About Life Sciences Results At ITC

  

  A look at recent U.S. International Trade Commission case data shows that pharmaceuticals, medical devices and other life sciences products constitute a growing share of the technologies involved in Section 337 investigations, with overwhelmingly positive results for companies seeking to protect their IP rights from foreign competitors, say Brian Busey and Daniel Muino at MoFo.

• Series

  ESG Around The World: Japan

  

  Japan is witnessing rapid developments in environmental, social and corporate governance policies by making efforts to adopt a soft law approach, which has been effective in encouraging companies to embrace ESG practices and address the diversity of boards of directors, say Akira Karasawa and Landry Guesdon at Iwata Godo.

• How And Why Your Firm Should Implement Fixed-Fee Billing

  

  Amid rising burnout in the legal industry and client efforts to curtail spending, pivoting to a fixed-fee billing model may improve client-attorney relationships and offer lawyers financial, logistical and stress relief — while still maintaining profit margins, say Kevin Henderson and Eric Pacifici at SMB Law Group.

• Potential Broader Effects Of FDA's Lab-Developed Test Rule

  

  Though it's unclear whether the U.S. Food and Drug Administration's proposed rule for regulating lab-developed tests will ever go into effect, it nonetheless functions as a threatened hammer that may make legislative efforts to regulate such tests more palatable, say attorneys at King & Spalding.

• Opinion

  Judicial Independence Needs Defense Amid Political Threats

  

  Amid recent and historic challenges to the judiciary from political forces, safeguarding judicial independence and maintaining the integrity of the legal system is increasingly urgent, says Robert Peck at the Center for Constitutional Litigation.

• 2 New Ways FDA Is Changing Lab-Developed Test Regulation

  

  The U.S. Food and Drug Administration's recently announced rulemaking and voluntary pilot program signal the agency's dedication to ramping up oversight of lab-developed tests, which have been largely unregulated by the FDA until now, say attorneys at Sidley.

• FDI Considerations For UK Venture Capital Transactions

  

  With the U.K. National Security and Investment Act highlighting foreign direct investment matters for venture capital transactions, investors dealing with companies connected to the U.K. should be alive to how the act's requirements can affect deal timelines, structures and terms, say lawyers at Covington.