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.

• NY's Growing Enviro Reg Framework Will Transform Projects

  

  Three closely connected environmental rulemakings in New York state — concerning greenhouse gas reporting, remediation standards and amendments to the State Environmental Quality Review Act — have reached critical stages, and taken together, they will have major impacts on business operations, construction project timelines and transactional risk, say attorneys at Holland & Knight.

• How 'Spillover' Effects Can Skew AI Securities Class Actions

  

  Event study evidence is often central in securities litigation at class certification and beyond, but in an environment where earnings forecasts and statements can have spillover market implications, particularly when concerning artificial intelligence, the task of parsing out the price impact of news requires careful consideration, say Erik Johannesson, Olivia Wurgaft and Nguyet Nguyen at Brattle Group.

• 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.

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  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.

• 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.

• 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.

• How Food, Beverage Claims May Preview Cosmetic Litigation

  

  Class action litigation targeting cosmetics and personal care products is accelerating, with a playbook that comes from the food and beverage industry — and the defenses that succeeded, and failed, in past class actions offer a critical road map for beauty and personal care brands, say attorneys at Crowell.

• 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.

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  Officiating Football Makes Me A Better Lawyer

  

  Though they may seem to have little in common, officiating football has sharpened many of the same skills that define effective lawyering in management-side labor and employment: preparation, judgment, composure, credibility and ability to make difficult decisions in real time, says Josh Nadreau at Fisher Phillips.

• Fresenius Ruling May Shift Anti-Kickback Enforcement

  

  The Ninth Circuit's recent decision in Fresenius v. Bonta suggests that businesses have a First Amendment right to donate to certain charities, even if those donations are motivated by economic self-interest, potentially calling into question years of Anti-Kickback Statute proceedings against pharmaceutical manufacturers for making similar donations, says Jonah Knobler at Patterson Belknap.

• Written Consent Ruling May Signal Change For Telemarketing

  

  The Fifth Circuit's ruling in Bradford v. Sovereign Pest Control is a takedown of the Federal Communications Commission's prior express written consent regulation, and because Loper Bright empowers courts to disregard agency interpretations, Telephone Consumer Protection Act litigants now have an opportunity to challenge previously settled FCC regulations, orders and interpretations, say attorneys at Manatt.