Expert Analysis

• Previewing FDA Preapproval Access In Psychedelics EO

  

  The second of two pathways for psychedelic drug access outlined in President Donald Trump's recent executive order constitutes an unprecedented expansion of the Right to Try Act, which could fundamentally alter the psychedelic access landscape while presenting significant regulatory, operational and legal challenges, say attorneys at Husch Blackwell.

• Previewing FDA National Priority Vouchers In Psychedelics EO

  

  President Donald Trump's recent executive order on psychedelic drug access represents a watershed moment in federal drug policy, but its significance lies in two distinct regulatory pathways, the first being the Commissioner's National Priority Vouchers, which offer a significant opportunity to compress U.S. Food and Drug Administration review, say Kimberly Chew at Husch Blackwell and Odette Hauke at Odette Alina.

• Series

  Playing Magic: The Gathering Makes Me A Better Lawyer

  

  The competitive card game Magic: The Gathering offers me a training ground for the strategic thinking skills crucial to litigation, challenging me to adapt to oft-updated rules, analyze text as complicated as any statute and anticipate my opponent’s next moves, says Christopher Smith at Lash Goldberg.

• Why Product-Based Public Nuisance Claims May Be Waning

  

  The Maryland Supreme Court's recent decision in Express Scripts v. Anne Arundel County is the latest in a national trend of rulings rejecting product-based public nuisance claims — but other forms of government litigation against companies that allegedly increase the cost of public services are likely to continue, say attorneys at Simpson Thacher.

• What's At Stake For Employers In Fight Over Visa Pause

  

  For employers that rely on foreign talent, the Trump administration’s suspension of immigrant visa issuance for the nationals of 75 countries is creating practical problems, and a recently filed lawsuit challenging the pause could determine whether consular processing, for some, ceases to be an individualized process, says attorney Lisa Eisenberg.

• Improving Well-Being In Law, 10 Years After Landmark Study

  

  An important 2016 study revealed significant substance abuse and mental health issues among lawyers, and while the findings helped normalize the conversation around these topics, a decade later, structural change is still needed, says Denise Robinson at PLI.

• How To Gear Up For Trump's Pharma Tariffs

  

  President Donald Trump's proclamation establishing tariffs on certain pharmaceutical products holds a few areas of ambiguity that companies should review and prepare for before the tariffs come into effect later this year, say attorneys at Arnold & Porter.

• AG Watch: Texas Charts A Course On Investigative Authority

  

  The Texas Supreme Court's recent decision in Texas v. PFLAG affirmed, and arguably expanded, the Texas attorney general's civil investigative demand authority, providing a road map that other courts evaluating state attorney general CIDs may find instructive, amid a lack of precedent, say attorneys at Kelley Drye.

• Initial Virginia AG Actions Signal Focus On Multistate Efforts

  

  Now that Virginia Attorney General Jay Jones has reached the 100-day mark in office, his first set of actions reveals a clear preference for coalition with regional and national counterparts, which means the primary risk for businesses is no longer just the fact of enforcement, but the speed at which investigations can escalate, says Lauren Cooper at Hogan Lovells.

• How CMS Fraud Priorities Complicate Provider Acquisitions

  

  As the Centers for Medicare & Medicaid Services steps up usage of its affiliates authority and post-transaction audits, parties contemplating the acquisition or sale of home health and hospice providers should take steps to avoid the potential suspension of Medicare billing privileges, say attorneys at Alston & Bird.

• Mapping Philly US Atty's White Collar Enforcement Push

  

  Attorneys at Blank Rome discuss the U.S. Attorney for the Eastern District of Pennsylvania David Metcalf’s commitments and priorities, survey early results from his first year, and suggest practical action items for companies operating under the office's jurisdiction.

• How The Coming Months Will Shape State Drug Price Boards

  

  The future of state prescription drug affordability boards may be determined in the next few months, between an upcoming court decision in a challenge against state authority to set drug prices, and pending state decisions about whether to use federal Medicare maximum fair prices as reference, say Michael Kolber, Steven Chen and Kelechi Ezealaji at Manatt.

• High Court 'Skinny Label' Case Will Matter To Tech Litigators

  

  Hikma v. Amarin, set for oral argument in the U.S. Supreme Court on Wednesday, has potential to affect not just generic drug label-based evidence in patent cases, but also how technology inducement cases are presented and proven, says attorney Abdul Abdullahi.

• Steps To Consider As DOJ Launches Fraud Division

  

  The establishment this month of the National Fraud Enforcement Division within the U.S. Department of Justice is a significant reorganization that suggests an increase in enforcement activity involving federally funded programs but leaves a number of important questions unanswered, say attorneys at Crowell & Moring.

• Court's HRSA Policy Reversal Leaves 340B Rules Murky

  

  A D.C. federal court's recent decision in Premier v. U.S. Department of Health limits the Health Resources and Services Administration's ability to enforce long-standing Section 340B interpretations through subregulatory guidance, leaving open core statutory questions about purchasing models, inventory classification and program oversight, says Martha Cramer at Hooper Lundy.