Policy & Compliance

Expert Analysis

• 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.

• 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.

• How Law Firms Can Use Account-Based Marketing Strategies

  

  Amid several evolving legal industry trends, account-based marketing can help law firms uncover additional revenue-generating opportunities with existing clients, with key considerations ranging from data analytics to relationship building, say Jennifer Ramsey at stage LLC and consultant Gina Sponzilli.

• AGs' Distaste For Food Bill May Signal Other State Issues

  

  States' recent opposition to a proposed federal law that would block them from regulating out-of-state agricultural production could affect issues beyond this narrow debate, such as the balance of state and federal regulatory power, reproductive rights post-Dobbs, and energy production and water use, say Christopher Allen and Stephen Cobb at Cozen O'Connor.

• Strategic Succession Planning At Law Firms Is Crucial

  

  Senior partners' reluctance to retire, the rise of the nonequity partner tier and generational differences in expectations are all contributing to an increasing number of departures from BigLaw, making it imperative for firms to encourage retirement among senior ranks and provide clearer leadership pathways to junior attorneys, says Laura Leopard at Leopard Solutions.

• What An NCAA Drug Test Change Could Mean For Cannabis

  

  If the NCAA follows through with its decision to remove cannabis from its banned list of substances, it will affect college athletes, athletic directors, public relations employees, and marketing departments at universities and colleges, and it will have a significant economic effect on the cannabis industry, say Stanley Jutkowitz and Sydney Jenkins at Seyfarth.

• When Calif. Health Shield Law Reaches Beyond State Borders

  

  In light of California's newly signed shield law to increase protections for reproductive health and gender-affirming care, it's important to understand how the law's covered services and key legal protections could affect patients and providers nationwide, says Natalie Birnbaum at Nelson Hardiman.

• FDA's Lab-Developed Test Rule Faces High Hurdles

  

  The U.S. Food and Drug Administration's recently announced plans to explicitly regulate lab-developed tests will likely face resistance from industry stakeholders and congressional actions, and lead to significant litigation, say attorneys at Hogan Lovells.

• FTC's Health Co. Suit Indicates Agency's Private Equity Focus

  

  The Federal Trade Commission's latest lawsuit against an anesthesia company and its private equity investor highlights the agency's willingness to regulate the health care industry even when relevant acquisitions are relatively dated or when the controlling entity's economic interest is under 50%, say attorneys at Simpson Thacher.

• What Marijuana Status Change Would Mean For Industry

  

  If the Drug Enforcement Administration accepts the U.S. Department of Health and Human Services’ recent recommendation to change marijuana’s classification under federal law, it would be a significant regulatory shift that could foster many industry benefits — but questions, risks and uncertainties at both the state and federal levels would remain, say attorneys at Neal Gerber.

• Top 4 Antitrust Enforcement Issues In Health Care Today

  

  The Federal Trade Commission's recent lawsuit against U.S. Anesthesia Partners exemplifies antitrust enforcement authorities' efforts to aggressively reshape the health care industry, ranging from new proposed rules to withdrawals of previous guidance, say attorneys at Fried Frank.

• Calif. Climate Disclosure Bills Promise Challenges For Cos.

  

  Two novel climate disclosure bills recently passed by the California Legislature will pose challenges for many businesses — especially private companies that are less familiar with climate-related reporting obligations — and will require investments of significant time and effort in processes, procedures and personnel, say John Rousakis and Chris Bowman at O'Melveny.