FDA Issues Final Order Downclassifying Certain IVDs

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.

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.

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...

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.

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.

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.

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.

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.

The Code is voluntary, but it will likely become an important reference point for demonstrating compliance with Article 50 of the AI Act.

The Ninth Circuit Court of Appeals vacated a preliminary injunction against Perplexity AI, determining that when an AI agent acts at a user's direction, it is the user—not the AI company—who "accesses" computer systems under federal and California computer fraud statutes. This landmark appellate decision addresses how existing computer-access laws apply to agentic artificial intelligence and has significant implications...

The New York Stock Exchange and Nasdaq are implementing overnight trading sessions starting December 6, 2026, extending the trading day to nearly 23 hours by compressing the daily pause to just one hour. While this evolution toward continuous trading introduces new considerations for corporate actions, disclosure timing, and deal execution, the practical impact varies significantly between NYSE-listed companies,

China's Supreme People's Court has issued comprehensive judicial rules addressing artificial intelligence disputes, establishing frameworks for product liability, intellectual property rights, and data protection. These landmark opinions provide critical guidance for global companies navigating AI-related legal risks in China's evolving regulatory landscape.

The Ninth Circuit has ruled that health plan participants whose confidential information was disclosed without authorization have standing to sue in federal court, even without showing financial loss or future harm. This decision, which departs from the risk-based approach many courts have applied since TransUnion, relies on the centuries-old action for breach of confidence and could have significant implications for companies' privacy commitments and data-sharing practices.

The European Commission has initiated infringement procedures against 20 EU Member States for failing to transpose the EmpCo Directive by the March 27, 2026 deadline. This directive aims to combat greenwashing by requiring substantiation of environmental claims and third-party certification for sustainability labels, with full implementation expected by September 27, 2026.

Mexico's comprehensive anti-money laundering framework has undergone a sweeping transformation through Acuerdo 115/2026, introducing mandatory risk-based methodologies, enhanced client due diligence protocols, and automated monitoring requirements. With implementation deadlines beginning March 1, 2027, obligated parties conducting vulnerable activities face compressed timelines to overhaul their compliance infrastructure while navigating heightened enforcement risks and stricter beneficial ownership thresho

The European Commission has proposed replacing the EU's three core procurement directives with a single, directly applicable Regulation that would fundamentally reshape how companies compete for public contracts across Member States. The reform introduces mandatory quality criteria thresholds, embeds ESG considerations as evaluation factors, and establishes new security and European-preference provisions that could restrict participation based on ownership, supply chain exposure, and strategic dependencies.

A federal court has struck down New York's Climate Change Superfund Act, which sought to recover $75 billion from fossil fuel companies based on historical emissions. The ruling found the Act preempted by the Clean Air Act, marking the first judicial decision on state climate superfund legislation and establishing that EPA's rescission of the endangerment finding does not alter preemption analysis.

The Illinois Holocaust Museum & Education Center (IHMEC) held a third program as part of its Jones Day Foundation Community Series, a special series of educational events