In the past month, President Trump signed two executive orders concerning drug access and affordability, including for biologics and biosimilar drugs. On April 15, 2025, President Trump signed Executive Order No. 14273 (“EO 273”), titled “Lowering Drug Prices By Once Again Putting Americans First.” Then, on May 12, 2025, President Trump signed an executive order titled “Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients” (“the MFN EO”). Both Executive Orders seek to tackle various drug pricing and accessibility issues and provide a high-level policy blueprint for the Trump Administration.
MFN EO. According to the order, its purpose is to address an “imbalance” in how much the United States pays for pharmaceutical products compared to other countries. As discussed in this week’s Goodwin Alert, it appears that the executive order seeks to place the burden to “equalize” prices across countries compared to the United States first on the foreign countries that demand deep ex-U.S. discounts on prices and the manufacturers that acquiesce to these price demands. The MFN EO instructs the Department of Health and Human Services (“HHS”) to identify MFN target pricing and to take steps to incentivize direct-to-consumer purchasing for certain drugs. The MFN EO also outlines a process for various administrative agencies to determine further enforcement actions if “significant progress towards most-favored-nation pricing for American patients is not delivered.” This Executive Order comes days after another Executive Order, “Regulatory Relief to Promote Domestic Production of Critical Medicines,” designed to eliminate regulatory barriers that inhibit domestic manufacturing of drugs by ordering FDA to review and streamline existing regulations, enhance the efficiency of inspections, and even subject foreign drug manufacturing facilities to increased scrutiny and fees.
Further details on the MFN EO are available in Goodwin’s Client Alert.
EO 273. EO 273 states that “[i]t is the policy of the United States that Federal health care programs, intellectual property protections, and safety regulations are optimized to provide access to prescription drugs at lower costs to American patients and taxpayers.” EO 273 identifies 13 directives related to that policy, with many of those directives specific to the Secretary of Health and Human Services (“the Secretary”).
Several directives expressly seek to increase the number of available prescription and over-the-counter drugs for Americans by directing various agencies to propose guidance and recommendations on how to reduce Medicare drug prices, Medicare Part D premiums, and “align the treatment of small molecule prescription drugs with that of biological products, ending the distortion that undermines relative investment in small molecule prescription drugs, coupled with other reforms to prevent any increase in overall costs to Medicare and its beneficiaries.”
EO 273 also directs the FDA to issue a report providing recommendations on how to accelerate approval of “generics, biosimilar, combination products, and second-in-class brand name medications,” and how to improve the process of reclassifying prescription drugs as over-the-counter drugs. It requires the Secretary to issue a report with recommendations on how to “reduce anti-competitive behavior from pharmaceutical manufacturers.”
One directive expressly addresses pharmacy benefit managers and says that the “Secretary of Labor shall propose regulations” “to improve employer health plan fiduciary transparency into the direct and indirect compensation received by pharmacy benefit managers.” Finally, another directive expressly focuses on the costs associated with insulin and injectable epinephrine and requires the Secretary to ensure that certain grants “are conditioned upon health centers establishing practices to make insulin and injectable epinephrine available at or below the discounted price paid by the health center grantee or sub-grantee” “to individuals with low incomes, as determined by the Secretary.”
At this time, it is unclear how these directives will impact the pharmaceutical drug industry, and especially the market for biologics and biosimilars. Stay tuned as Big Molecule Watch continues to follow any potential regulatory and legislative developments arising from these executive orders.