Insights

On October 29, 2026, the Federal Trade Commission (FTC) and attorneys general from Colorado, Florida, Illinois, Iowa, Nebraska, Oklahoma, and Utah, joined by Los Angeles County Counsel and the San Francisco City Attorney, sued Toast over allegedly deceptive advertising, hidden fees, and cancellation barriers. The bipartisan lawsuit shows that federal, state, and local regulators continue to work together on consumer protection, including claims involving business customers. Like the Seek Capital, First American Payment Systems, and newly announced Riverside Payments matters discussed below, the Toast case concerns allegedly misleading sales claims, unexpected costs, and difficulty canceling services, this time in restaurant technology.

On October 16, 2026, the U.S. Centers for Medicare and Medicaid Services (CMS) issued a proposed rule implementing key sections of the Consolidated Appropriations Act (CAA) of 2026, Section 6224 (“Modernizing and Ensuring Pharmacy Benefit Manager Accountability”). The agency also proposes a conforming change mandated by section 6219 of the CAA (“Adjustments to Medicare Part D Cost-Sharing Reductions for Low-Income Individuals”) that would reduce the generic-drug copayment from $1 to $0 for full-benefit dual eligible individuals. Comments to the proposed rule are due December 15, 2026.   

On October 1, 2026, Judge Brian M. Cogan of the U.S. District Court for the Eastern District of New York denied NYP’s motion to dismiss a consolidated antitrust complaint brought by three self-funded union health plans. The ruling is significant for two reasons. First, it demonstrates that plaintiffs can successfully allege market power against hospital systems even in the absence of traditionally high market shares. Second, the court’s reasoning closely tracks the arguments advanced by the DOJ in its Statement of Interest filed in the case: that market power need not be established through market share alone and can be shown through direct evidence such as supracompetitive pricing, and that exclusionary conduct and rival foreclosure are not required elements of a Section 1 claim. The recent decision validates the government’s legal theories and could enhance the viability of the DOJ’s parallel action against NYP, which is currently proceeding in the Southern District of New York.

On October 1, 2026, the U.S. Department of Justice’s (DOJ) National Fraud Enforcement Division issued Directive 26-12: Corporate Enforcement in the Fight Against Fraud. Assistant Attorney General Colin M. McDonald’s October directive follows his August 2026 memorandum setting the Division’s enforcement priorities. The directive signals — in the DOJ’s words — “an aggressive, all-tools” enforcement posture across the Division’s health care, government contracting, tax, and trade fraud priorities, while simultaneously supporting the incentives designed to promote transparency, reward cooperation, and encourage voluntary disclosure of misconduct. 

The rapid emergence of AI/ML tools in drug discovery, from target identification to generative molecular design, lead optimization, and repurposing, has transformed how life sciences companies build some of their most valuable assets. As AI/ML tools take on an increasingly significant role in the drug discovery process, companies face a set of largely unresolved IP challenges that require careful planning and proactive governance.  

When federal law enforcement agencies issue subpoenas to companies for information about their customers, the subpoenas or cover letters often contain boilerplate nondisclosure language. This language generally directs companies not to notify those customers and implies that there may be legal consequences for doing so. But as two lawmakers recently called out in a formal letter to the U.S. Supreme Court and the U.S. Government Accountability Office (GAO), this boilerplate language may not carry the force of law.

The U.S. Food & Drug Administration (FDA) is seeking feedback on a regulatory framework that could be used to evaluate generative artificial intelligence (GenAI)-enabled medical devices. Such devices could create new types of risks because their outputs can vary and evolve, unlike more traditional software-enabled devices. An August 18, 2026, discussion paper (“Considerations for the regulation of GenAI-enabled medical devices”) discusses potential regulatory considerations for GenAI-enabled medical devices. 

Enbrel (etanercept) is one of the best-selling biologic drugs in the United States, approved to treat rheumatoid arthritis and other serious inflammatory conditions. Etanercept was launched as Enbrel in 1998 as a treatment for moderate to severe rheumatoid arthritis, and was later approved to treat additional inflammatory diseases including plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and polyarticular juvenile idiopathic arthritis.  

On August 19, 2026, the Federal Trade Commission (FTC) announced a proposed Enforcement Policy Statement on personalized pricing — the practice of companies using consumers’ personal data to set individualized prices, discounts, coupons, or other incentives. The proposed statement, which is open for public comment for 30 days following publication in the Federal Register, marks a major step up in the FTC’s focus on data-driven pricing strategies and puts businesses across industries on notice that undisclosed or inadequately disclosed personalized pricing will not be tolerated. Importantly, while the proposed statement is not a binding legal requirement and does not create new legal obligations, it serves as an enforcement warning that the FTC is prepared to use its existing enforcement authority under Section 5 of the FTC Act (Section 5) and is also a potential harbinger of rulemaking. Businesses that engage in — or are considering — personalized pricing should carefully assess their disclosure practices and data collection procedures against the standards articulated in this statement.

On July 22, 2026, Missouri Attorney General Catherine L. Hanaway filed a federal lawsuit against the city of Kansas City, Missouri, challenging the city’s longstanding Minority and Women Business Enterprise (MWBE) program as unconstitutional. The AG filed the complaint in the U.S. District Court for the Western District of Missouri alongside private plaintiffs Charles Cacioppo Jr. and his company, Industrial Salvage and Wrecking Co.

The United States had barely finished blowing out 250 candles on its birthday cake when the Federal Trade Commission (FTC) decided to remind corporate America what “Made in USA” is actually supposed to mean. On July 6, 2026, the FTC sent a pointed message to the marketplace: unsubstantiated “Made in USA” claims will not go unnoticed. The FTC sent warning letters to several companies advertising products as “Made in USA” — and, in at least one case, “Made in Texas” — despite information suggesting that the products were imported in whole or in significant part.

RICO was built for the mob. But Congress gave trade secret victims access to it in 2016, and a recent U.S. Court of Appeals for the Fifth Circuit decision shows that access is real.

In June 2026, federal regulators and lawmakers continued their efforts to improve drug affordability through targeted reforms. These recent developments will primarily impact pharmaceutical manufacturers, managed care organizations, and pharmacy benefit managers (PBM) serving Medicare Part D program members. PBMs, Medicare Advantage organizations, and Part D sponsors should monitor these changes in the interest of maintaining compliance and providing input on regulatory proposals that may influence their business operations or compensation structures in the future.

On the surface, United States v. Bankman-Fried is a case about the collapse of a cryptocurrency exchange. But the U.S. Court of Appeals for the Second Circuit’s recent opinion — affirming Samuel Bankman-Fried’s conviction on seven counts of fraud and conspiracy — carries important lessons that extend well beyond the world of digital assets.

On April 10, 2026, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule (2026 CMS Interoperability Standards and Prior Authorization for Drugs, or CMS-0062-P) outlining the agency’s plans to impose new interoperability requirements on payors participating in certain Medicare and Medicaid programs. As described by the agency in a recent press release, the proposed rule “builds on” prior rulemaking by clarifying and enhancing interoperability requirements for payors’ prior authorization processes, specifically those associated with coverage requests for pharmaceutical therapies.

The Federal Trade Commission (FTC) recently released its Strategic Plan for Fiscal Years 2026–2030, setting out the agency’s enforcement priorities and operational objectives for the next five years under Chairman Andrew N. Ferguson. The plan reaffirms the FTC’s commitment to vigorously enforcing the nation’s antitrust and consumer protection laws “without fear or favor.” Critically for businesses, the plan returns the phrase “without unduly burdening legitimate business activity” to the agency’s mission statement, signaling a commitment to ending what the agency characterizes as overregulation of businesses that compete fairly and deal honestly with consumers. Despite this business-friendly framing, the plan signals robust enforcement across consumer protection, antitrust, and emerging technology — areas that will directly affect in-house counsel’s compliance planning over the coming years.

The U.S. Court of Appeals for the Federal Circuit recently decided in Bd. of Trs. of Columbia Univ. v. Gen Digital Inc., No. 2024-1243 (Fed. Cir. 2026) that the district court erred in its denial of judgment as a matter of law as to damages resulting from foreign sales of downloadable software. At Columbia University's request, the jury had been instructed that “Columbia [was] entitled to damages based on sales to customers located outside of the United States if . . . the infringing product sold to those customers was made in or distributed from the United States, even if the infringing product [was] delivered to and used by the customer outside the United States.” The court concluded as a matter of law that the software sold to Gen Digital‘s (Norton) foreign customers was made outside the United States, and therefore the $94 million in foreign sales damages could not stand.

As pharmaceutical weight-loss therapies have surged in popularity, health plans, regulators, and courts have found themselves grappling with a set of increasingly pressing and complex questions: who must cover these drugs, under what circumstances, and for whom?

The New Jersey Legislature is considering two bills, that if enacted, would prohibit business entities from using either consumers' personal data or “personalized algorithmic pricing” to set prices for merchandise or services, including groceries. If enacted, the new laws would have broad implications for companies across industries that rely on algorithmic or data-informed pricing strategies. In her recent State Budget Address, New Jersey Governor Mikie Sherrill pledged to sign the proposals into law if they reach her desk.

On March 10, 2026, the Department of Justice released the first-ever Department-wide Corporate Enforcement and Voluntary Self-Disclosure Policy (the “Department-wide CEP” or “Policy”), which applies to all non-antitrust corporate criminal cases across the Department. The new policy has been anticipated since December 2025, when Deputy Attorney General Todd Blanche announced the Department’s plans to release a new, single corporate enforcement policy for all criminal matters. According to the Department, the new policy is designed to “help ensure consistency across the Department” and “transparently describe the Department’s policies and decisionmaking.”