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Expert Analysis

• FDA's Hasty Policymaking Approach Faces APA Challenges

  

  Though the U.S. Food and Drug Administration has abandoned its usual notice-and-comment process for implementing new regulatory initiatives, two recent district court decisions make clear that these programs are still susceptible to Administrative Procedure Act challenges, says Rachel Turow at Skadden.

• DOJ Crypto Enforcement Is Shifting To Target Willfulness

  

  Three pending criminal prosecutions could be an indication of how the U.S. Department of Justice's recent digital assets memo is shaping enforcement of the area, and show a growing focus on executives who knowingly allow their platforms to be used for criminal conduct involving sanctions offenses, say attorneys at Gibson Dunn.

• Legal Considerations Around Ibogaine As Addiction Therapy

  

  Recent funding approval in Texas pertaining to the use of ibogaine for the potential treatment of substance use disorders signals a growing openness to innovative addiction treatments, but also underscores the need for rigorous compliance with state and federal requirements and ethical research standards, say attorneys at Husch Blackwell.

• How NJ's Proposed Privacy Rules Could Reshape AI Data Use

  

  Although not revolutionary, New Jersey's proposed privacy rules would create obligations around the management and processing of consumer personal data that will require careful planning before they can be successfully implemented, say attorneys at Norton Rose.

• Why SEC Abandoned Microcap Convertible Debt Crackdown

  

  The U.S. Securities and Exchange Commission has recently dismissed several cases targeting microcap convertible debt lenders, a significant disavowal of what was a controversial enforcement initiative under the Biden administration and a message that the new administration will focus on clear fraud, say attorneys at O'Melveny.

• The Metamorphosis Of The Major Questions Doctrine

  

  The so-called major questions doctrine arose as a counterweight to Chevron deference over the past few decades, but invocations of the doctrine have persisted in the year since Chevron was overturned, suggesting it still has a role to play in reining in agency overreach, say attorneys at Crowell & Moring.

• A Rapidly Evolving Landscape For Noncompetes In Healthcare

  

  A wave of new state laws regulating noncompete agreements in the healthcare sector, varying in scope, approach and enforceability, are shaped by several factors unique to the industry and are likely to distort the market, say attorneys at Seyfarth.

• Protecting Workers Amid High Court-EEOC Trans Rights Rift

  

  In Ames v. Ohio Department of Youth Services and U.S. v. Skrmetti, the U.S. Supreme Court clarified that Title VII protects employees from discrimination based on sexual orientation and gender identity, so employers should still protect against such discrimination despite the U.S. Equal Employment Opportunity Commission's unclear position, says Ally Coll at the Purple Method.

• Arguing The 8th Amendment For Reduction In FCA Penalties

  

  While False Claims Act decisions lack consistency in how high the judgment-to-damages ratio in such cases can be before it becomes unconstitutional, defense counsel should cite the Eighth Amendment's excessive fines clause in pre-trial settlement negotiations, and seek penalty decreases in post-judgment motions and on appeal, says Scott Grubman at Chilivis Grubman.

• Business Takeaways Following CCPA Enforcement Actions

  

  Advisories and recent enforcement activity by the California Privacy Protection Agency against Honda and Todd Snyder underscore the agency's enforcement interest in the intersection of data minimization and consumer rights, and could make it more challenging for a business to provide a streamlined consumer rights process, say attorneys at Covington.

• Compliance Lessons From 1st-Ever Product Safety Sentences

  

  A California federal judge’s recent sentencing of two former Gree USA executives in a landmark Consumer Product Safety Act case serves as a reminder of the federal government’s willingness to pursue criminal prosecution of individuals who fail to report safety hazards, as well as companies’ need to strengthen their reporting and compliance programs, say attorneys at Cooley.

• GENIUS Act Creates 'Commodity' Uncertainty For Stablecoins

  

  Half a century ago, Congress made trading in onion futures on commodity exchanges unlawful, and payment stablecoins could soon face a similarly unstable fate in the markets as the GENIUS Act heads to the president's desk for signature, says Peter Malyshev at Cadwalader.

• 9th Circ. Decisions Help Clarify Scope Of Legal Lab Marketing

  

  Two Ninth Circuit decisions last week provide a welcome development in clarifying the line between laboratories' legal marketing efforts and undue influence that violates the Eliminating Kickbacks in Recovery Act, and offer useful guidance for labs seeking to mitigate enforcement risk, says Joshua Robbins at Buchalter.

• $95M Caremark Verdict Should Put PBMs On Notice

  

  A Pennsylvania federal judge’s recent ruling that pharmacy benefits manager CVS Caremark owes the government $95 million for overbilling Medicare Part D-sponsored drugs highlights the effectiveness of the False Claims Act, as scrutiny of PBMs’ outsized role in setting drug prices continues to increase, say attorneys at Duane Morris.

• Cos. Face Convergence Of Anti-Terrorism Act, FCPA Risks

  

  Recent moves by the U.S. Department of Justice to classify cartels and transnational criminal organizations as terrorist groups, and to use a range of statutes including the Foreign Corrupt Practices Act to pursue these types of targets, mean that companies operating in certain jurisdictions are now subject to overlapping exposure, say attorneys at Miller & Chevalier.