Health Care Law Today

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.

On March 5, 2025, two Senators and one Representative introduced SB 25-198, designed to enhance transparency in transactions involving health care entities.

In the evolving health care landscape, mergers between nonprofit health care organizations are becoming increasingly common.

On February 21, 2025, California introduced AB 1415, a bill aimed at expanding the regulatory oversight of the Office of Health Care Affordability.

PYA and Foley & Lardner hosted the 7th Annual “Let’s Talk Compliance” two-day virtual conference on January 23 and 24, 2025. Panelists included Foley attorneys and PYA subject matter experts. The event was hosted by Foley partner, Jana Kolarik, and PYA consulting principal, Angie Caldwell. Here are the key takeaways from each session.

The Medicare program continues to face long term financial pressures associated with inflationary effects on health care costs and the growing wave of aging baby boomers. The Medicare Trust Fund, which is often viewed as a foil for health care affordability, has long faced a proverbial financing question.

Recently, a new class of drugs, based on GLP-1, are revolutionizing medicine and the treatment of patients with diabetes, obesity, and other disorders associated with obesity.

Immunotherapies have provided successful precision therapy for human diseases by reducing side effects caused by untargeted...