Policy & Compliance

Expert Analysis

• 5 Drug And Device Developments That Shaped 2024

  

  The last year saw significant legal developments affecting drug and device manufacturers, with landmark decisions and regulatory changes that require vigilance and agility from the industry, say attorneys at Faegre Drinker.

• How New Fraud Enforcement Tool Affects Gov't Contractors

  

  Government contractors will likely face greater scrutiny under the recently enacted Administrative False Claims Act, which broadens federal agencies' authority to pursue low-dollar fraud claims, but contractors may also find the act makes settlement of such claims easier to negotiate, say attorneys at Wiley.

• Consultants Should Be Aware Of DOJ's Potential New Reach

  

  The U.S. Department of Justice's recent first-of-its-kind settlement with McKinsey & Co. indicates not only the DOJ's more aggressive stance toward businesses' potential criminal wrongdoings, but also the benefits of self-disclosure and cooperation when wrongdoing becomes apparent, says Dom Caamano at Kibler Fowler.

• Health Tech Regulatory Trends To Watch In 2025

  

  With an upcoming change in administration and the release of some long-awaited rules, the healthcare industry should prepare for shifting trends, including a growing focus on health data and interest in technology-enabled delivery of healthcare, say attorneys at Orrick.

• 10 Noteworthy CFPB Developments From 2024

  

  In a banner year for consumer finance regulation, the Consumer Financial Protection Bureau made significant strides in its efforts to rein in Big Tech and nonbank financial firms, including via rules regarding open banking, credit card late fees, and buy now, pay later products, say attorneys at Wiley.

• 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.