The Top FCA Developments of 2025
Client Alert | 1 min read | 03.23.26
False Claims Act (FCA) settlements and judgments hit record highs yet again in FY 2025, surpassing the previous record by over $1 billion and setting a new high-water mark for the number of new FCA cases filed. These records were built both on existing enforcement priorities such as pandemic-related fraud and healthcare enforcement actions and new guidance from the Executive Branch instructing the Department of Justice to enforce its 2025 priorities including Diversity, Equity, and Inclusion (DEI), civil rights, and customs issues. Procurement fraud, cybersecurity issues, and small business fraud also remained focal points, with significant settlements in each of those areas. In the courts, an Eleventh Circuit decision expanded relators’ ability to use discovery to avoid dismissal under Rule 9(b), and a Ninth Circuit ruling clarified a number of customs fraud issues while applying the Supreme Court’s Schutte scienter test. Debate over the qui tam provisions’ constitutionality continued to grow, with arguments made in multiple circuits, including an Eleventh Circuit oral argument in the appeal of the Middle District of Florida’s Zafirov decision that helped to spark the recent wave of challenges. Crowell FCA attorneys explain these developments, trends, and what’s next for the FCA in a “Feature Comment” published in The Government Contractor.
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Client Alert | 5 min read | 04.13.26
EU Pharma Package: Global (Orphan) Marketing Authorization Compromise Proposal
In our fifth alert in this EU Pharma Package Series, we provided an analysis of the background and ongoing legal debates regarding the concept of the global marketing authorization (GMA). We discussed in particular the missed opportunities in the Pharma Package to further codify and clarify the GMA, in view of its central role in determining the regulatory data protection (RDP) rights of a medicinal product.
Client Alert | 4 min read | 04.10.26
CMS Finalizes Rate Notice for Medicare Parts C and D (CY 2027)
Client Alert | 2 min read | 04.10.26
Client Alert | 4 min read | 04.10.26
FTC Issues Five-Year Strategic Plan: What Businesses Need to Know







