Responding To FINRA's Insider Trading Inquiries

On March 5, 2025, one U.S. District Court ruled unequivocally in the Food & Drug Administration’s (FDA) favor in the case, Outsourcing Facilities Ass’n, et. al. v. U.S. Food and Drug Admin., et. al., 4:24-cv-0953-P, slip op., 2025 WL 746028, at *15  (N.D. Tex. Mar. 5, 2025), denying plaintiffs’ motion for (1) a preliminary injunction (PI) prohibiting the FDA from taking action against Outsourcing Facilities Association (OFA) members and FarmaKeio based on their compounding of the drug ingredient tirzepatide pending final judgment in the case and (2) a stay pending conclusion of the review proceedings in response to the FDA’s declaration that the shortage of the diabetes and weight-loss tirzepatide products has been resolved.  

GLP-1 receptor agonists were initially approved for diabetes treatment (e.g., Ozempic®) but have revolutionized weight management (e.g., Wegovy®) and are now being explored for treating a wide range of health conditions.

It is well-settled that under Article III of the Constitution, United States federal courts are limited to trying “cases and controversies.”