FDA Issues "Biosimilars" Draft Guidelines

The U.S. Department of Health and Human Services and FDA have submitted an interim access policy for peptide compounding to regulatory review, but no peptides have yet been added to the official list allowing pharmacies to compound them. While advisory committee votes in July 2026 recommended six peptides for inclusion, formal rulemaking has not begun, and any near-term access would likely come through temporary enforcement discretion rather than full approval.

On October 23, 2026, the U.S. House Committee on Oversight and Government Reform announced an investigation into whether the three largest pharmacy benefit managers (PBMs)—CVS Caremark, Express Scripts and Optum...

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.

Senator Maria Cantwell has proposed a comprehensive AI governance framework that could fundamentally reshape how health insurance plans deploy artificial intelligence in prior authorization and utilization management. With explicit focus on CMS's WISeR model and requirements for meaningful human oversight, the framework signals potential federal mandates that would require health plans to audit AI systems, ensure transparency in consequential decisions, and maintain accountability for AI-related harms.

U.S. House Representative Frank Pallone Jr. has introduced legislation that would fundamentally restructure the No Surprises Act by eliminating its independent dispute resolution process after 2027 and replacing it with a recalculated qualifying payment amount as the mandatory out-of-network payment rate.

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...

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.

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

California's Office of Health Care Affordability has approved sweeping new regulations that dramatically expand transaction review requirements for private equity groups, hedge funds, and management services organizations acquiring or investing in healthcare entities.