CMS Posts Final HIPAA Administrative Simplification Transaction Testing Checklists

The FDA has escalated enforcement against online peptide sellers through warning letters and criminal prosecution, while state medical boards impose stricter standards on prescribers. Recent actions reveal how research-use-only disclaimers fail when evidence shows intended human use, and one case resulted in a 70-month prison sentence combined with $5 million forfeiture.

Welcome to FDA in Flux — A Mintz newsletter tracking rapid changes in policy and agency actions that impact medical, life sciences, and consumer product investment decisions and development strategies.

The Trump administration's most-favored-nation pricing initiative has expanded to include nine additional mid-sized pharmaceutical manufacturers, bringing the total coverage to 89% of the brand drug market. These new agreements focus on Medicaid pricing discounts aligned with international rates, while manufacturers commit billions to U.S. manufacturing and research in exchange for exemptions from future pricing mandates and potential tariffs.

The U.S. Food and Drug Administration has released a discussion paper outlining its initial framework for regulating generative AI-enabled medical devices, proposing a two-axis risk assessment approach and a novel competency-based premarket evaluation system. With public comments due by October 19, 2026, this represents a critical opportunity for device manufacturers and stakeholders to shape the regulatory landscape for this transformative technology.

Over the past year, industry has had a front row seat as the Food and Drug Administration (“FDA” or the “Agency”) decides just how much leeway it wants to afford the manufacture, marketing, and sale of peptide products, and just where it wants to draw the line. Despite the recent decision of FDA’s Pharmacy Compounding Advisory Committee (“PCAC”) to recommend a number of peptides for inclusion on the 503A bulks list process — a move that represents a potentially more permissive stance toward peptide regulation, at least in terms of what can and cannot be compounded under 503A...

In Snyder v. Virginia Mason Medical Center, No. 104136-5 (Wash. Oct. 1, 2026), the Washington Supreme Court held that corporate defense counsel, risk managers, and claims adjusters may not communicate ex parte with a hospital’s former employee health care providers about patient care. The Court reaffirmed Loudon v. Mhyre, 110 Wn.2d 675, 756 P.2d 138 (1988) prohibiting ex parte communication by defense counsel with a plaintiff’s treating physicians, held that prejudice is presumed when Loudon is violated, and ruled that a quality improvement (QI) committee member’s involvement in defense strategy waives the committee’s statutory privilege under Wash. Rev. Code § 70.41.200.

As previously reported, the FDA’s Pharmacy Compounding Advisory Committee (PCAC) recently voted in favor of adding six peptides—BPC-157, KPV, TB-500...

In October 2025, California Governor Gavin Newsom signed Assembly Bill 1503 into law, marking a significant change for pharmacies located outside California...

On Friday, California Office of Health Care Affordability (“OHCA”) published proposed final regulations that implement a 2026 law that significantly expanded OHCA’s review authority over health care transactions involving private equity (“PE”) groups, hedge funds, and management services organizations (“MSOs”). Stakeholders involved in California health care transactions should re-assess whether their ongoing or contemplated transactions are implicated by these regulations, because newly covered transactions will need to comply with the 90-day advance notice requirement established in the original OHCA regulations.

The FDA, in collaboration with federal partners, held a landmark public hearing on September 14, 2026, to gather input on the future therapeutic use of psychedelic drugs, drawing over 18,000 registered attendees. This hearing represents one of the earliest implementations of Executive Order 14401, which directs federal agencies to expedite research, review, and approval of psychedelic drugs for serious mental health conditions.