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On April 15, 2025, President Donald J. Trump signed an titled “Lowering Drug Prices by Once Again Putting Americans First.� This order aims to reduce prescription drug costs through various measures, focusing on transparency, competition, and middleman reform. While many directives are Medicare or Medicaid focused, there may be the potential to indirectly impact employer-sponsored pharmacy benefits.

As a reminder to our readers, executive orders are directives aimed at federal government agencies and do not, by themselves, require immediate action from public or private sectors. They direct agencies on how to implement and enforce existing laws, and their impact depends on whether they lead to regulatory changes. Additionally, executive orders can be challenged in federal court if deemed unconstitutional or conflicting with existing laws.

Trump’s executive order regarding drug prices is extensive. A short list of provisions that may (or may not) have an indirect impact on employer-sponsored prescription drug plans is described below.

Transparency in Pharmacy Benefit Manager (PBM) Fees: The Department of Labor (DOL) is directed to propose new ERISA regulations requiring PBMs to disclose all direct and indirect compensation. This measure aims to empower plan sponsors to better assess PBM contracts and identify hidden fees.

Timing: The Secretary of the DOL is directed to issue proposed regulations within 180 days of the order.

340B Access for the Uninsured and Underinsured: Federally Qualified Health Centers may soon be required to offer insulin and epinephrine at or below 340B prices (plus minimal fees) to low-income individuals with high cost-sharing, unmet deductibles, or no insurance. This could potentially reduce emergency medication costs for qualified employees and dependents.

Timing: The Secretary is directed to take action within 90 days of the order to ensure future grants are only available to federally funded health centers that establish practices to comply with the specifics of this demand.

Acceleration of Generic and Biosimilar Approvals: The order includes a directive to fast-track FDA approval of generics and biosimilars, which could increase competition and drive down drug costs, benefiting employer plans through lower net costs over time.

Timing: The EO directed the Secretary to provide administrative and legislative recommendations within 180 days of the date of the order.

Section 804 Importation Programs: The order aims to facilitate improvements related to the under Section 804.  This pathway already exists but is only available to states and Indian tribes. Additionally, the process for gaining FDA approval has proved complex and arduous for states, and only one state has been approved so far, and they’ve not yet taken steps to import drugs. This move shines a light on international Rx outsourcing, especially those interested in importing prescription drugs for employer-sponsored programs.

Timing: The Secretary, via the Commissioner of Food and Drugs, has 90 days to take steps to “streamline and improve� the current Section 804 drug importation pathway for states to obtain approval to import drugs.

Summary

There is no action necessary at this time other than monitoring the news for more developments. As mentioned previously, the impact an executive order has depends on whether it leads to regulatory changes. While President Trump’s executive order on lowering drug prices could lead to significant step towards reducing prescription drug costs, its full impact remains to be seen.

obÌåÓý will continue to monitor regulator guidance and offer meaningful, practical, timely information. This material should not be considered as a substitute for legal, tax and/or actuarial advice. Contact the appropriate professional counsel for such matters. These materials are not exhaustive and are subject to possible changes in applicable laws, rules, and regulations and their interpretations.

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