Insights

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.”

A recent decision by the United States Court of Appeals for the Fifth Circuit, Farmers Texas County Mutual Insurance Co. v. 1st Choice Accident & Injury, LLC, No. 24-20275 (5th Cir. Feb. 24, 2026), offers important lessons for health care payors and other potential plaintiffs considering civil claims under the federal Racketeer Influenced and Corrupt Organizations Act (RICO). Although the Fifth Circuit’s decision focused on a procedural issue, the underlying case turned on a fundamental pleading failure: the plaintiff insurers did not adequately describe the fraudulent network they were suing as a RICO “enterprise.” The result was dismissal of a $14 million fraud case.

On February 10, 2026, California enacted Senate Bill 25 (“SB 25”), known as the California Uniform Antitrust Pre-Merger Notification Act. The new law takes effect on January 1, 2027, making California the third state—following Washington (effective July 27, 2025) and Colorado (effective August 6, 2025)—to implement a “mini-HSR” regime modeled after the Uniform Antitrust Pre-Merger Notification Act (“UAPNA”). The legislation reflects the growing state-level focus on merger oversight, and it signals California’s continuing intent to increase early pre-merger scrutiny and concurrent review of transactions with federal authorities.

By the end of 2025, 16 drug manufacturers had voluntarily negotiated and executed agreements to adopt Most Favored Nation (MFN) pricing for certain high-cost drugs. The Trump Administration highlighted the agreements in its “Great Healthcare Plan,” published on January 15, 2026, and communicated the government’s plans to “codify” such deals as a means of “get[ting] Americans the same low prices that people in other countries pay.” The Administration recently leveraged MFN pricing to establish the TrumpRx website, which helps uninsured or cash-paying consumers find drugs at a discounted price. The website reflects the Administration’s stated commitment to provide more lower-cost drugs directly to consumers. Currently, 40 branded medications are available at reduced prices.

On July 8, 2025, the U.S. Court of Appeals for the Eighth Circuit vacated the Federal Trade Commission’s (FTC) Rule Concerning Subscriptions and Other Negative Option Plans, commonly known as the “Click-to-Cancel” rule. As detailed in a previous client alert, the rule was intended to regulate negative option plans[1]— such as subscriptions and automatic renewals — by imposing stringent requirements on businesses, including streamlined cancellation processes and enhanced disclosure obligations. The Eighth Circuit vacated the Click-to-Cancel rule because it found that the FTC had failed to comply with mandatory procedural requirements. As a result, the rule is no longer in effect, and businesses are not currently subject to its mandates.

On February 3, 2026, President Trump signed a $1.2 trillion spending deal that, among other points, introduced significant regulatory changes for Medicare Part D plans and PBMs providing services to PDP sponsors in the Medicare Advantage and Medicare Part D programs, and imposed significant new restrictions and transparency requirements on PBMs contracting with private group health plans.

New York Governor Kathy Hochul has signed into law the most significant update to New York’s consumer protection law in 45 years — the Fostering Affordability and Integrity through Reasonable Business Practices Act, or FAIR Business Practices Act — expanding the scope of the state’s authority to now challenge unfair and abusive business practices. The measure, backed by New York Attorney General (“AG”) Letitia James and signed on December 19, 2025, amends New York’s General Business Law § 349, giving regulators new tools to protect consumers and promote fair marketplace practices.