The Top FCA Developments of 2023
Client Alert | 1 min read | 03.12.24
2023 brought many important False Claims Act developments for companies with business involving government funds. While overall recoveries remained down compared to pre-2022 levels, the total number of settlements and judgments exceeded any prior year. Those settlements and judgments also highlight areas of particular focus for the Government, including cybersecurity compliance, pandemic fraud, and small business fraud, among others. Of particular note, 2023 saw the U.S. Supreme Court issue decisions concerning the Government’s authority to dismiss qui tam actions and the critical element of scienter/knowledge that will have wide-reaching impact. The courts of appeals also issued significant decisions on damages, materiality, and more. Crowell attorneys discuss these highlights and others in a "Feature Comment" published in The Government Contractor.
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Client Alert | 4 min read | 04.29.24
Red Alert on the Orange Book: The FTC Continues to Crack Down on Improperly Listed Drug Patents
As reported in an earlier Client Alert, on November 7, 2023, the Federal Trade Commission challenged 100 patents as improperly listed in the Food and Drug Administration’s “Approved Drug Products with Therapeutic Equivalence Evaluations” publication, commonly known as the Orange Book. The FTC sent warning letters to ten drug and medical device manufacturers identifying patents for inhalers, autoinjectors and anti-inflammatory multi-dose bottles that the FTC believes are improperly listed. In the letters, the FTC indicated it is using the FDA’s regulatory dispute process to challenge the listing of these patents in the Orange Book because improperly listed patents may violate antitrust laws and impede competition.
Client Alert | 3 min read | 04.26.24
CFIUS Proposes Enhanced Enforcement and Mitigation Rules and Steeper Penalties for Non-Compliance
Client Alert | 3 min read | 04.25.24
JUST RELEASED: EPA’s Bold New Strategic Civil-Criminal Enforcement Collaboration Policy
Client Alert | 6 min read | 04.25.24
