Defective Pricing & the False Claims Act
Client Alert | 1 min read | 05.21.19
The enactments of the False Claim Act (FCA) and the Truth in Negotiations Act (TINA) were separated by nearly 100 years, yet the two statutes have become kissing cousins, with many defective pricing cases turning into fraud actions. In Defective Pricing & the False Claims Act, published in the April 2019 issue of Thomson Reuters’s Briefing Papers, Crowell & Moring attorneys discuss: (1) the historical factors and practical warning signs linking defective pricing and FCA actions; (2) the burdens and elements of proof in TINA and FCA litigations and how certain elements may overlap and even bolster defenses to both defective pricing and fraud actions; and (3) the procedural elements of TINA and FCA actions—such as stays of proceedings, evidentiary standards, and statutes of limitation—and where these factors may determine the outcomes in both defective pricing and fraud proceedings.
Insights
Client Alert | 2 min read | 05.09.25
FDA Seeks Stakeholder Consultation on Prescription Drug User Fee Reauthorization
On May 8, the U.S. Food and Drug Administration (FDA) took steps to begin the process for reauthorizing the Prescription Drug User Fee Amendments (PDUFA) by announcing a public meeting to be held on July 14, 2025. The agency invited public stakeholders, including patient and consumer advocate groups, health care professionals, and scientific and academic experts to participate in the meeting and subsequent public meetings to consult on the PDUFA reauthorization.
Client Alert | 2 min read | 05.09.25
New SF-328 for Foreign Ownership, Control, and Influence Assessments Approved, Publication Imminent
Client Alert | 4 min read | 05.08.25
Client Alert | 4 min read | 05.07.25
