Insights

On May 12, 2025, President Trump issued an Executive Order titled "Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients," which aims to reduce the costs of prescription drugs and biologics for American consumers and other payers. This Order revives a plan from President Trump’s first term and follows his April Executive Order, “Lowering Drug Prices by Once Again Putting Americans First,” which also sought to reduce drug prices. With drug prices in the United States nearly three times higher than many other countries, this second Order asks drug manufacturers to adopt Most-Favored-Nation (MFN) pricing for drugs sold in the United States or face potential regulation. MFN pricing would tether drug prices offered in the United States to the lower-cost prices offered in other comparably developed nations, such as Canada, Germany, or the United Kingdom.

On April 29, 2025, the Supreme Court heard oral argument in Laboratory Corporation of America Holdings, dba Labcorp, v. Luke Davis, et al., No. 22-55873. The Supreme Court had granted a petition for writ of certiorari in the case as to the following question: “[w]hether a federal court may certify a class action pursuant to Federal Rule of Civil Procedure 23(b)(3) when some members of the proposed class lack any Article III injury.” The Justices focused much of the oral argument on whether the case was moot, suggesting they may not reach the merits. And when soliciting argument on the merits, the Court appeared divided as to how to answer the question.

On January 24, 2025, the United States Supreme Court agreed to hear a case that could resolve whether putative Rule 23(b)(3) classes may be certified in the federal courts when some of the class members are uninjured. Or, as the Supreme Court put the certified question in the case, Laboratory Corporation of America Holdings, dba Labcorp, v. Luke Davis, et al., No. 22-55873:

On December 20, 2024, the Federal Circuit affirmed a district court’s holding that five device patents had been improperly listed in the Orange Book by Teva Pharmaceuticals, Inc. as claiming a drug, and ordering that they be delisted.

As reported in earlier Client Alerts, on November 7, 2023, the Federal Trade Commission challenged 100 patents as improperly listed in the Food and Drug Administration’s “Approved Drug Products with Therapeutic Equivalence Evaluations” publication, commonly known as the Orange Book. The FTC sent warning letters to ten drug and medical device manufacturers identifying patents for inhalers, autoinjectors and anti-inflammatory multi-dose bottles that the FTC believes are improperly listed. In response, some manufacturers withdrew their patents, and others agreed to cap certain out-of-pocket costs for their drugs, resulting in a “victory lap” of media activity from the FTC in April.

The Food and Drug Administration (FDA) has published revised draft guidelines in the Federal Register on promotional labeling and advertising considerations for the biologic and biosimilar industry, updating guidance from 2020. The quick revisions emphasize the fast-changing and rapidly growing nature of this industry.

As reported in an earlier Client Alert, on November 7, 2023, the Federal Trade Commission challenged 100 patents as improperly listed in the Food and Drug Administration’s “Approved Drug Products with Therapeutic Equivalence Evaluations” publication, commonly known as the Orange Book. The FTC sent warning letters to ten drug and medical device manufacturers identifying patents for inhalers, autoinjectors and anti-inflammatory multi-dose bottles that the FTC believes are improperly listed. In the letters, the FTC indicated it is using the FDA’s regulatory dispute process to challenge the listing of these patents in the Orange Book because improperly listed patents may violate antitrust laws and impede competition.    

On April 12, 2024, the Tenth Circuit issued a decision in I DIG Texas LLC v. Kerry Creager, which analyzed country-of-origin claims in a manner that diverged from the well-established Federal Trade Commission’s “Made in USA” policy.

Following federal lawmakers’ initiative to lower prescription drug prices under the Inflation Reduction Act of 2022, several states have taken similar steps to limit certain drugs’ prices. Drug affordability for consumers is a top priority for federal and state lawmakers and regulators because it is a bipartisan issue that directly impacts consumers’ wallets. With negotiations between the federal government and drug manufacturers over 10 drugs’ prices for Medicare beneficiaries well underway under the Inflation Reduction Act, 11 states, including Maryland and Colorado, have created drug affordability review boards to more directly tackle rising prices for both brand and generic drugs.[1] And another 12 states have pending legislation to create these boards.[2] 

In late December, the FDA released a guidance document that provides clarity for small businesses marketing direct-to-consumer (DTC) drug products on television or radio.  The Q&A followed the FDA’s November 2023 Final Rule amending DTC advertising regulations for prescription drugs. 

On July 7, 2022, the Federal Trade Commission (“FTC” or “Commission”) announced it is acting against grill manufacturer Weber-Stephen Products, LLC, arguing that Weber’s warranties illegally restrict consumers’ right-to-repair. The Weber complaint is the third salvo in the FTC’s recent string of right-to-repair administrative complaints, after issuing two similar complaints against Harley-Davidson Motor Company Group, LLC and MWE Investments, LLC mere weeks prior. The FTC’s recent action thus signals that it will continue prioritizing enforcement of tying rules under the Magnuson Moss Warranty Act (“MMWA”).