Policy & Compliance

Expert Analysis

• FDA Commissioner Speech Suggests New Vision For Agency

  

  In his first public remarks as U.S. Food and Drug Administration commissioner, Marty Makary outlined an ambitious framework for change centered around cultural restoration, scientific integrity, regulatory flexibility and selective modernization, and substantial enforcement shifts for the food and tobacco sectors, say attorneys at Arnall Golden.

• Customs Fraud Enforcement In The Age Of Tariffs

  

  In the wake of the Trump administration’s new approach toward tariffs, two recent Justice Department developments demonstrate aggressive customs fraud enforcement, with the DOJ emphasizing competitive harm to American businesses, and signaling that investigations will likely involve both civil and criminal enforcement tools, say attorneys at Bernstein Litowitz and London & Naor.

• Legal Risks For Providers Discussing Psychedelic Therapies

  

  The emergence of psychedelic therapies as potential treatments for mental health conditions and other ailments continues to garner significant attention, but the legal landscape surrounding discussions and referrals remains fraught with complexity, creating potential risks for healthcare providers and institutions, says Kimberly Chew at Husch Blackwell.

• How NY's FAIR Act Mirrors CFPB State Recommendations

  

  New York's proposed FAIR Business Practices Act, which targets predatory lending and junk fees, reflects the Rohit Chopra-era Consumer Financial Protection Bureau's recommendations to states in a number of ways, including by defining "abusive" conduct and adding a new right to file class actions, says Christian Hancock at Bradley Arant.

• A Breakdown Of Trump's Order On Drug Pricing

  

  The Trump administration may attempt to effectuate through rulemaking a recently issued executive order on lowering drug prices, which would likely have an adverse effect on stakeholders and trigger litigation, say attorneys at Debevoise.

• Takeaways From DOJ's 1st Wage-Fixing Jury Conviction

  

  U.S. v. Lopez marked the U.S. Department of Justice's first labor market conviction at trial as a Nevada federal jury found a home healthcare staffing executive guilty of wage-fixing and wire fraud, signaling that improper agreements risk facing successful criminal prosecution, say attorneys at McGuireWoods.

• Deregulation Memo Presents Risks, Opportunities For Cos.

  

  A recent Trump administration memo providing direction to agencies tasked with rescinding regulations under an earlier executive order — without undergoing the typical notice-and-review process — will likely create much uncertainty for businesses, though they may be able to engage with agencies to shape the regulatory agenda, say attorneys at Blank Rome.

• The IRS Shouldn't Go To War Over Harvard's Tax Exemption

  

  If the Internal Revenue Service revokes Harvard's tax-exempt status for violating established public policy — a position unsupported by currently available information — the precedent set by surviving the inevitable court challenge could undercut the autonomy and distinctiveness of the charitable sector, says Johnny Rex Buckles at Houston Law Center.

• New Hospice Regulations Should Enforce Core Principles

  

  As the U.S. Department of Health and Human Services' Office of Inspector General prepares to research and expand on oversight of Medicare hospice care, the OIG should keep in mind certain core principles, such as an emphasis on preventing the entry of hospices that raise red flags, says Bill Dombi at Arnall Golden.

• 7 Considerations For Conducting Drug Clinical Trials Abroad

  

  With continuing cuts to U.S. Food and Drug Administration staffing motivating some pharmaceutical companies to consider developing drugs abroad, it's important to understand the additional risks and compliance requirements associated with conducting clinical studies in other countries, say attorneys at Morgan Lewis.

• Compliance Lessons From Warby Parker's HIPAA Fine

  

  The U.S. Department of Health and Human Services' civil money penalty against Warby Parker highlights the emerging challenges that consumer-facing brands encounter when expanding into healthcare-adjacent sectors, with Health Insurance Portability and Accountability Act compliance being a potential focus of regulatory attention, say attorneys at Saul Ewing.

• 5th Circ. Ruling Is Latest Signal Of Shaky Qui Tam Landscape

  

  In his recent concurring opinion in U.S. v. Peripheral Vascular Associates, a Fifth Circuit judge joined a growing list of jurists suggesting that the False Claims Act's whistleblower provisions are unconstitutional, underscoring that acceptance of qui tam relators can no longer be taken for granted, say attorneys at Miller & Chevalier.

• Medicare Advantage Enforcement Strong Amid Agency Cuts

  

  The second Trump administration's actions thus far suggest that Medicare Advantage enforcement remains a bipartisan focus despite challenges presented by evolving trends in federal agency staffing and resources, say attorneys at Ropes & Gray.