FDA Bill Shows Risk Of Inexact Statute Text, Post-Loper Bright

A recent House bill to amend the Food and Drug Administration's drug preclusion framework reveals the increased importance of precision when drafting statutory rules in a post-Loper Bright landscape, as several minor errors in the text could lock in unintended results that will be difficult to repeal, say attorneys at Venable.

Species 'Harm' Definition Rollback Brings Risk For Developers

A rule recently adopted by federal agencies rescinds the definition of "harm" in Endangered Species Act regulations to exclude habitat destruction — but while the move is aimed at reducing regulatory burdens, it creates new uncertainty for developers, and may trigger increased environmental protections in California, say attorneys at Cox Castle.

$95M Nev. Case Provides Clues On Wound Care Enforcement

Federal prosecutors’ recent U.S. v. Dubin indictment, charging a Nevada physician with healthcare fraud over an alleged $95 million Medicare billing scheme involving amniotic wound allografts, provides a clearer picture of an increasingly data-driven enforcement strategy that follows the entire wound care transaction, say attorneys at Bass Berry.

DOJ Fraud Memo Highlights Trade Enforcement Playbook

A recent U.S. Department of Justice memo that outlines the Fraud Enforcement Division's priorities demonstrates that customs and trade fraud enforcement has entered a new and far more aggressive phase, with recent cases highlighting how the False Claims act is driving the new push, say attorneys at Foley & Lardner.

HPE-Juniper Settlement Teaches Key Tunney Act Lessons

A California federal court's recent approval of the U.S. Department of Justice's settlement with Hewlett Packard over its Juniper Networks acquisition offers legal practitioners some crucial lessons, including on unique tech-sector remedies for mergers and acquisitions and the continued viability of the Tunney Act, says Shubha Ghosh at Syracuse University College of Law.

What Opt-In Framework Means For Novel Space Activities

The U.S. Department of Commerce's Office of Space Commerce is advancing a voluntary certification framework for commercial space activities not covered by existing licenses — but it's unclear whether this approach becomes a durable mission authorization regime, and separate legal permissions from agencies may still be necessary, say attorneys at Morgan Lewis.

Negotiating The Scope Of The Stablecoin Customer ID Rule

Though comments on bank regulators’ proposed rule for stablecoin issuers under the Genius Act generally agree that oversight would help prevent illicit activity, agencies must reconcile disagreement over whether to extend customer identification requirements from issuers' primary-market relationships to secondary-markets activity, say attorneys at Ballard Spahr.

How To Improve Hiring Transparency Amid Ghost Job Scrutiny

Recent regulatory and state law scrutiny of ghost job postings for roles that don't exist or aren't being filled signals a shift toward hiring transparency, and employers that fail to adapt risk enforcement actions, consumer protection claims and financial penalties, say attorneys at Foley & Lardner.

FTC Push May Create Dual Origin-Claim Risks For Contractors

Recent Federal Trade Commission actions involving Made in USA advertising requirements offer a preview of enforcement themes that may impose dual compliance burdens on government contractors that are also subject to Federal Acquisition Regulation Buy American restrictions, says Amy Hoang at Seyfarth.

Series

Playing Bid Whist Makes Me A Better Lawyer

As a child, I viewed bid whist as a family tradition and a source of friendly card game competition, but as a lawyer, I see it as a tool that has helped me cultivate skills like communication, teamwork, risk assessment and composure, says Keyonn Pope at Riley Safer.

FCC Robotics Restrictions Raise AI Compliance Risks

A recent "covered list" update from the Federal Communications Commission places restrictions on foreign-produced advanced robotic devices’ ability to obtain new authorizations, creating a framework that is poorly suited to continuous artificial intelligence updates, and raising several transactional and contractual challenges, says Kim Larsen at Stinson.

Navigating Employer Obligations Under NY Personnel File Law

In light of a New York law that will soon give private sector employees the right to review and comment on their personnel files, employers should understand where their exposure lies and be mindful of where records are stored, and for how long, among other things, says attorney Jason Tenenbaum.

Banks Should Stay Disciplined As OCC, FDIC Ease Oversight

Despite a newly issued Office of the Comptroller of the Currency and the Federal Deposit Insurance Corp. rule that narrows the range of conduct that regulators may require institutions to remediate, prudent risk management suggests banks should still document how they arrive at their risk determinations, say attorneys at Crowell & Moring.

Tracking Trends In State-Level Regulatory Enforcement

State-level enforcement now increasingly involves antitrust, artificial intelligence and data privacy issues, and the key for organizations to reducing risk is having the ability to respond across governance, public affairs, discovery and remediation in multiple states simultaneously, say consultants at FTI Consulting.

Opinion

The Time Is Right To Simplify Overlapping Broker-Dealer Regs

While the U.S. Securities and Exchange Commission has made an important start to simplifying its rules, legislators should follow and expand on the commission's example by reexamining and removing the unnecessary overlap between SEC, Financial Industry Regulatory Authority and state broker-dealer regulations, says Howard Spindel at Integrated Solutions.