Policy & Compliance

Expert Analysis

• How Citizen Petitions Have Affected Drug Competition

  

  In light of recent citizen petitions and proposed legislation regulating such petitions, Omar Robles at Managing Health analyzes the statistics of the extent to which citizen petitions have been filed, and to what extent they have delayed competition in prescription pharmaceuticals.

• Drug Kickback Ruling Will Make FCA Liability Harder To Prove

  

  The First Circuit's ruling in U.S. v. Regeneron Pharmaceuticals, requiring the government to prove but-for causation to establish False Claims Act liability based on violations of the Anti-Kickback Statute, raises the bar for FCA enforcement and deepens a circuit split that the U.S. Supreme Court may need to resolve, say attorneys at Baker Donelson.

• Assessing PE Risk After Mass. False Claims Act Amendments

  

  A law recently passed in Massachusetts amends the commonwealth's False Claims Act by dramatically expanding potential liability for private equity firms and investors, underscoring the importance of robust diligence and risk assessments for private equity firms conducting transactions in the commonwealth, say attorneys at Gibson Dunn.

• What Trump Actions Mean For Federal Research Funding

  

  New guidance from the National Institutes of Health represents a massive policy shift regarding federal funding for researchers at institutions of higher education, contributing to a perfect storm of significant resource shortfalls in upcoming years, say attorneys at Arnold & Porter.

• A Look At Healthcare Transaction Oversight In Oregon

  

  Understanding Oregon's enforcement authority and its impact on proposed transactions last year provides a road map to the state's plans to strengthen its processes this year, though enforcement could be challenged by ongoing litigation, say attorneys at Ropes & Gray.

• Rethinking 'No Comment' For Clients Facing Public Crises

  

  “No comment” is no longer a cost-free or even a viable public communications strategy for companies in crisis, and counsel must tailor their guidance based on a variety of competing factors to help clients emerge successfully, says Robert Bowers at Moore & Van Allen.

• High Court Must Acknowledge US History Of Anti-Trans Laws

  

  Despite Justice Amy Coney Barrett's claim to the contrary during oral arguments in U.S. v. Skrmetti, U.S. governments at every level have systematically discriminated against transgender people, and the U.S. Supreme Court must consider this historical context in upcoming cases about transgender issues, says Paisley Currah at the City University of New York.

• The Fate Of Biden-Era Clinical Study Guidance Under Trump

  

  Draft guidance about the study of sex and gender differences in medical product development issued by the outgoing Biden administration currently faces significant uncertainty and litigation potential due to the Trump administration's executive orders and other actions, say attorneys at Arnold & Porter.

• 10 Issues To Watch In Aerospace And Defense Contracting

  

  This year, in addition to evergreen developments driven by national security priorities, disruptive new technologies and competition with rival powers, federal contractors will see significant disruptions driven by the new administration’s efforts to reduce government spending, regulation and the size of the federal workforce, say attorneys at Thompson Hine.

• Dispelling 10 Myths About Health Provider-Based Compliance

  

  Congress appears intent on requiring hospitals to submit provider-based attestations for all off-campus outpatient hospital locations, so now is the time for hospitals to prepare for this change by understanding common misconceptions about provider-based status and proactively correct noncompliance, say attorneys at McDermott.

• A Look At HHS' New Opinion On Patient Assistance Programs

  

  A recent advisory opinion from the U.S. Department of Health and Human Services' Office of Inspector General follows a recent trend of blessing patient assistance program arrangements that implicate the Anti-Kickback Statute, as long as they are structured with appropriate safeguards to minimize the risk of fraud and abuse, say attorneys at Sheppard Mullin.

• 2 Anti-Kickback Developments Hold Lessons For Biopharma

  

  The U.S. Department of Justice's Anti-Kickback Statute settlement with QOL Medical and a favorable advisory opinion from the U.S. Department of Health and Human Services provide a study in contrasts, but there are tips for biopharma manufacturers trying to navigate the vast compliance space between them, says Mary Kohler at Kohler Health Law.

• Tips For Pharma-Biotech Overlap Reporting In New HSR Form

  

  While there’s no secret recipe for reporting overlaps to the Federal Trade Commission in the new Hart-Scott-Rodino Act form, there are several layers of considerations for all pharma-biotech companies and counsel to reflect on internally before reporting on any deal, say attorneys at A&O Shearman.