Expert Analysis

• FDA Transparency Plans Raise Investor Disclosure Red Flags

  

  The U.S. Food and Drug Administration’s recently announced intent to publish complete response letters for unapproved drugs and devices implicates certain investor disclosure requirements under securities laws, making it necessary for life sciences and biotech companies to adopt robust controls going forward, say attorneys at Arnold & Porter.

• With Obligor Ruling, Ohio Justices Calm Lending Waters

  

  A recent decision by the Ohio Supreme Court, affirming a fundamental principle that lenders have no duty to disclose material risks to obligors, provides clarity for commercial lending practices in Ohio and beyond, and offers a reminder of the risks presented by guarantee arrangements, says Carrie Brosius at Vorys.

• Federal AI Action Plan Marks A Shift For Health And Bio Fields

  

  The Trump administration's recent artificial intelligence action plan significantly expands federal commitments across biomedical agencies, defining a pivotal moment for attorneys and others involved in research collaborations, managing regulatory compliance and AI-related intellectual property, says Mehrin Masud-Elias at Arnold & Porter.

• Preparing For DEA Rescheduling Of 2 Research Chemicals

  

  A recent decision to allow the U.S. Drug Enforcement Administration to reclassify two research psychedelics in Schedule I under the Controlled Substances Act may pose significant barriers to scientific study, including stringent registration requirements, heightened security protocols and burdensome reporting obligations, say Kimberly Chew at Husch Blackwell and Jackie von Salm at Psilera.

• 9th Circ.'s Kickback Ruling Strengthens A Prosecutorial Tool

  

  The Ninth Circuit's decision last month in U.S. v. Schena, interpreting the Eliminating Kickbacks in Recovery Act to prohibit kickback conduct between the principal and individuals who do not directly interact with patients, serves as a wake-up call to the booming clinical laboratory testing industry, say attorneys at Kendall Brill.

• Fla. Misses Opportunity To Rectify Wrongful Death Damages

  

  Florida Gov. Ron DeSantis' recent veto of a bill that would have removed certain arbitrary and unfair prohibitions on noneconomic wrongful death damages in medical negligence cases highlights the urgent need for reforms to current state law, say attorneys at Farah & Farah.

• A Shifting Trend In FDA Form 483 Disclosure Obligations

  

  A New York federal court's Checkpoint Therapeutics decision extends a recent streak of dismissals of securities class actions alleging that pharmaceutical companies failed to disclose U.S. Food and Drug Administration Form 483 inspection reports, providing critical guidance for companies during the FDA approval process, say attorneys at Alston & Bird.

• The Future Of Lab-Test Regs After FDA Rescinds Rule

  

  The U.S. Food and Drug Administration recently rescinded its laboratory-developed tests rule in response to a Texas federal court decision this spring, reinforcing a separation of authority between the FDA and the Centers for Medicare & Medicaid Services, and calling into question the FDA's role in overseeing such tests without congressional action, say attorneys at Venable.

• Unpacking Ore. Law's Limits On PE Healthcare Investment

  

  A recent Oregon law imposes significant restrictions on nonphysicians owning or controlling medical practices, but newly enacted amendments provide some additional flexibility in certain ownership arrangements without scuttling the law's intent of addressing concerns about the rise of private equity investment in healthcare, say attorneys at Debevoise.

• Criminal Healthcare Fraud Takeaways From 4th Circ. Reversal

  

  After the Fourth Circuit reversed a doctor’s postconviction acquittal in U.S. v. Elfenbein last month, defense attorneys should consider three strategies when handling complex criminal healthcare matters, says Jonathan Porter at Husch Blackwell.

• AG Watch: Texas Embraces The MAHA Movement

  

  Attorneys at Kelley Drye examine Texas Attorney General Ken Paxton's actions related to the federal Make America Healthy Again movement, and how these actions hinge on representations or omissions by the target companies as opposed to specific analyses of the potential health risks.

• How States Are Regulating Health Insurers' AI Usage

  

  The absence of a federal artificial intelligence framework positions states as key regulators of health insurers’ AI use, making it important for payors and service providers to understand the range of state AI legislation being passed in California and elsewhere, and consider implementing an AI-focused compliance infrastructure, say attorneys at Ropes & Gray.

• HHS Plan To Cut Immigrant Benefits Spurs Provider Questions

  

  A recent notice from the U.S. Department of Health and Human Services identifying new federal public benefit programs for which nonqualified aliens are not eligible may have a major impact on entities that participate in these programs — but many questions remain unanswered, say attorneys at Foley.