Insights

The deadline for Department of Health and Human Services (“HHS”) to notify approved manufacturers of acceptance into the 340B Rebate Model Pilot Program has passed, and stakeholders across the healthcare industry should start planning for compliance and operational changes. The Model Pilot Program may also face legal challenges that could delay or disrupt implementation.

California recently enacted two laws instituting new restrictions and requirements for health care transactions. On October 6, Governor Newsom signed SB 351, which codifies elements of the state’s corporate practice of medicine doctrine and strengthens restrictions against private equity, hedge fund, and other private investor control of health care organizations and operations. On October 11, Newsom signed AB 1415, which expands the scope of parties and relevant transactions that require pre-transaction notice to the state’s Office of Health Care Affordability (OHCA). Both laws are intended to provide the State of California greater oversight of transactions involving health care entities, and raise additional hurdles for parties seeking to acquire or sell health care operations in the state,[1] consistent with a broader trend across the country. The key points of each of the California laws are summarized below:

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 17, 2025, Arkansas recently became the first state to enact broad restrictions on pharmacy benefit managers (“PBMs”) owning retail pharmacies within the state.

California’s Assembly Bill 824 (“AB 824”) was enacted in October 2019 to curb “reverse payment” settlements among pharmaceutical companies that are used to resolve or settle patent infringement claims. The law establishes a presumption that such settlement agreements, through which a brand-name manufacturer compensates a generic manufacturer to forego its patent challenges in exchange for an agreement to enter at a later date (but before the expiration of the branded company’s patents), are anticompetitive and unlawful. AB 824 imposes significant financial penalties, with violators facing civil fines of up to three times the value received from the agreement or $20 million, whichever is greater.

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.    

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] 

On November 7, 2023, the Federal Trade Commission (“FTC”) announced it is challenging over 100 patents as improperly listed in the Food and Drug Administration’s (“FDA”) publication titled “Approved Drug Products with Therapeutic Equivalence Evaluations,” which is 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 listing patents may violate antitrust laws and impede competition. The FTC’s actions appear to be consistent with its recent and increased scrutiny of the healthcare and pharmaceutical industries.