GLP-1 Receptor Agonists: Drug Litigation Overview and Trends
The recent uptick and rise in popularity of GLP-1 drugs for addressing weight loss and obesity has led to an increase in U.S. litigation involving this class of drugs.
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Texas Court Vacates FDA’s Laboratory Developed Test (LDT) Final Rule
A Texas judge for the U.S. District Court for the Eastern District of Texas issued a ruling on March 31, 2025, to vacate and set aside, in its entirety, the U.S. Food and Drug Administration’s (FDA) Final Rule titled Medical Devices; Laboratory Developed Tests (LDTs)
Massachusetts: Expansion of Oversight Authority — New Notice of Material Change Form for Health Care Transactions
The Massachusetts Health Policy Commission, an independent state agency that works to improve affordability of health care for residents of the Commonwealth, released Advance Guidance for “Providers” and “Provider Organizations” considering transactions subject to the HPC’s updated Notice of Material Change process.
DEA Buprenorphine Rule Delayed to December 31, 2025
The U.S. Department of Health and Human Services and the Drug Enforcement Administration have postponed the effective date of the final rule regarding telemedicine prescribing of buprenorphine to December 31, 2025.
Telehealth Companies and Social Media Influencers May Face New FDA Laws
On February 20, 2025, U.S. Senators Dick Durbin (D-IL) and Roger Marshall, M.D. (R-KS) introduced bipartisan legislation, the Protecting Patients from Deceptive Drug Ads Act, which closes perceived “legal loopholes” in social media advertisements by telehealth companies.
Compounded GLP-1 Drugs: Texas Judge Denies PI Motion and Request for Stay of FDA’s Declaration that Tirzepatide Shortage is Resolved; Plaintiff OFA Appeals
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 and Patent Strategy: Securing Patent Protection for New Use of Old Drugs
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.
Colorado: Proposed Expanded Medical Care Transaction Oversight - What Providers and Investors Need to Know
On March 5, 2025, two Senators and one Representative introduced SB 25-198, designed to enhance transparency in transactions involving health care entities.
Nonprofit Health Care Mergers – Introduction: With Complexity Comes Opportunity
In the evolving health care landscape, mergers between nonprofit health care organizations are becoming increasingly common.
