CMS Proposes Transitional Coverage For Emergency Technologies

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.

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.

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.

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.

The Italian data protection authority fined IQVIA Solutions Italy €7 million for treating patient records as anonymous when they were actually pseudonymised personal data subject to GDPR. This decision demonstrates regulators' strict interpretation of what constitutes personal data, even as the EU considers narrowing this definition through the Digital Omnibus reforms.

California's new Senate Bill 574 introduces statutory duties for attorneys using generative AI, including mandatory citation verification and court disclosure requirements starting January 1, 2027. The law raises critical questions about how these obligations extend to AI-assisted eDiscovery review and document summarization that feed into court filings.

Generative AI is transforming litigation defense by enabling in-house legal teams to manage costs and complexity more effectively across the entire case lifecycle. From early research and drafting through expert witness strategy and trial preparation, AI tools are helping defense teams work faster and more consistently. How are these technologies reshaping the way sophisticated counsel approaches multidistrict litigation, mass torts, and large-scale document management?

The Federal Communications Commission has proposed sweeping changes to its equipment authorization program that would reorganize security restrictions around where devices are manufactured rather than who makes them. These new measures could fundamentally reshape how communications equipment—from smartphones to data center hardware—enters the U.S. market, with significant implications for manufacturers relying on foreign production.

A federal district court has preliminarily enjoined the EPA from reclassifying California's Clean Air Act preemption waiver orders as "rules" subject to the Congressional Review Act. The court found that EPA's reclassification likely violated the Administrative Procedure Act and exceeded the agency's authority, though the order does not prevent Congress from proceeding with pending disapproval resolutions.

Chinese authorities issued the first major update to criminal bribery laws in a decade, lowered thresholds for private-sector corruption crimes, and maintained aggressive enforcement against both bribe givers and receivers. Three senior officials faced prosecution in the first half of 2026, with investigations reaching back decades and emphasizing "family-style corruption" involving relatives who exploited officials' influence for personal gain.

Federal healthcare fraud enforcement leaders reveal a strategic shift at CMS and HHS-OIG, where administrative sanctions—including enrollment moratoria, revocations, and exclusions—now serve as the first line of defense against fraud, often preceding False Claims Act litigation. The panel discussion at AHLA's Fraud and Compliance Forum outlined how agencies are leveraging data analytics, financial crimes intelligence, and cross-program coordination to identify and shut down fraudulent providers

The Federal Trade Commission has introduced stringent new requirements for parties using technology-assisted review or artificial intelligence in document production during investigations, mandating extensive upfront disclosures, prescriptive performance metrics, and validation processes. These requirements represent a significant departure from previous FTC practice and may discourage parties from using AI or TAR due to increased complexity and agency oversight. Parties now face critical decisions about wh

US extradition proceedings are regulated by both treaty and US domestic legislation.

The Fifth Circuit's en banc decision in Sterling v. City of Jackson tests whether residents exposed to lead-contaminated municipal drinking water can sue under Section 1983 for substantive due process violations. In a 10-5 ruling, the court held that environmental harms caused by government mismanagement belong to tort law and the political process, not constitutional claims, creating a significant circuit split with implications for how environmental compliance failures by public officials are litigated.