Policy & Compliance

Expert Analysis

• The Future Of GLP-1 Policy After Drug Shortage Ends

  

  If and when the U.S. Food and Drug Administration determines that GLP-1 RA drugs are no longer in short supply, regulators will face questions of how to balance access to GLP-1 RAs with statutory and policy considerations applicable to compounded drugs, say attorneys at Skadden.

• Top 10 Whistleblowing And Retaliation Events Of 2024

  

  From a Florida federal court’s ruling that the False Claims Act’s qui tam provision is unconstitutional to a record-breaking number of whistleblower tips filed with the U.S. Commodity Futures Trading Commission, employers saw significant developments in the federal and state whistleblower landscapes this year, say attorneys at Proskauer.

• How White Collar Defense Attys Can Use Summary Witnesses

  

  Few criminal defense attorneys have successfully utilized summary witnesses in the past, but several recent success stories show that it can be a worthwhile trial tactic to help juries understand the complex decision-making at issue, says Jonathan Porter at Husch Blackwell.

• Nutraceutical Patent Insights As Market Heats Up

  

  Companies entering the expanding nutraceutical market and seeking patents to protect their innovations should evaluate successful nutraceutical claim language and common patent challenges in this field, say attorneys at Sterne Kessler.

• How White Collar Attys Can Use Mythic Archetypes At Trial

  

  A careful reading of a classic screenwriting guide shows that fairy tales and white collar trials actually have a lot in common, and defense attorneys would do well to tell a hero’s journey at trial, relying on universal character archetypes to connect with the jury, says Jack Sharman at Lightfoot Franklin.

• What 2024 Election Means For Drugs, Medicare And Medicaid

  

  With Republicans running the White House, U.S. House of Representatives and U.S. Senate, the incoming administration is likely to provide pathways — through new initiatives and others returning from Trump's previous presidency — for a range of potential changes to drug pricing, Medicare and Medicaid, say attorneys at Morgan Lewis.

• Justices Mull Sex-Based Classification In Trans Law Case

  

  After the U.S. Supreme Court heard oral argument in U.S. v. Skrmetti this week, it appears that the fate of the Tennessee law at the center of the case — a law banning gender-affirming healthcare for transgender adolescents — will hinge on whether the majority read the statute as imposing a sex-based classification, says Alexandra Crandall at Dickinson Wright.

• Key Takeaways From FDA's Latest Social Media Warnings

  

  The U.S. Food and Drug Administration's latest untitled letter concerning a drug company's social media promotion provides lessons for how companies should navigate risk presentation, FDA labeling requirements and superiority claims, say attorneys at Sheppard Mullin.

• Rank-And-File DOJ Attorneys Will Keep Calm And Carry On

  

  Career prosecutors at the U.S. Department of Justice often pride themselves on their ability to remain apolitical in order to ensure consistency and keep the department’s mission afloat, and the incoming Trump administration is unlikely to upend this tradition, says Michael Landman at Bird Marella.

• Unpacking Arguments From High Court's Rural Hospital Case

  

  During oral arguments in Advocate v. Becerra, the U.S. Supreme Court justices focused questions on the meaning of being "entitled to" supplementary security income assistance, and there's reason for optimism that the likely split decision will break in favor of hospitals, say attorneys at King & Spalding.

• Health Policy Predictions For Trump's Second Administration

  

  As President-elect Donald Trump's nominations for health policy and enforcement heads work their way through the confirmation process, healthcare organizations can look at nominee backgrounds, campaign statements and actions from Trump's previous presidency to predict incoming priorities, say attorneys at McDermott.

• What Trump's Next Term May Mean For Biz Immigration

  

  Leonard D'Arrigo at Harris Beach discusses the employment-based immigration policies businesses can potentially expect during President-elect Donald Trump’s second term, based on policies enacted during his first administration, statements made during his campaign and proposals in Project 2025.

• Weak Reasoning Underlies Fla. Judge's Bold Qui Tam Ruling

  

  U.S. District Judge Kathryn Mizelle's groundbreaking decision in U.S. ex rel. Zafirov v. Florida Medical Associates LLC, holding that qui tam provisions of the False Claims Act are unconstitutional, relies on weak logic to reach a conclusion that differs from every other court that has ruled on the issue, says Ethan Greenberg at Anderson Kill.