President Trump’s executive orders and legislative proposals from Congress leverage FDA to help lower drug prices, address anti-competitive practices, and accelerate generic drug approvals.

By J. Benneville (Ben) Haas and William A. McConagha

President Trump signed two executive orders in the last few months aimed at reducing prescription drug costs and addressing drug pricing strategies. On April 15, 2025, he signed an executive order titled “Lowering Drug Prices by Once Again Putting Americans First” in an effort to deliver on campaign promises to reduce the cost of prescription drugs stretching back to his first term in office. While the executive order is not particularly lengthy, it addresses 12 substantive areas related to drug pricing that may have an outsized impact on the biopharmaceutical industry. On May 12, 2025, the president reiterated his intent to use drug importation and anti-competition tools to help bring down the cost of drugs in the US in a second executive order, “Delivering Most-Favored Nation Prescription Drug Pricing to American Patients.”

Of particular interest are the sections that implicate the US Food and Drug Administration (FDA), including sections related to reviving the Section 804 drug importation program (commonly known as “SIP”) and accelerating the approval of generics and biosimilars as lower cost alternatives to brand name drugs and biologics.

The US Congress has also expressed a renewed interest in addressing the activities of pharmaceutical manufacturers that it perceives as anti-competitive or abusive. Thus far in 2025, the Senate Judiciary Committee under Senator Charles Grassley has proposed at least five pieces of legislation intended to accelerate generic drug and biosimilar approvals, increase competition, and limit perceived anti-competitive abuses within the biopharmaceutical industry. Many of these proposals identify FDA as a key stakeholder in achieving Congress’s goals.

In this Alert, we examine pertinent provisions of the executive orders and recently proposed federal legislation with respect to their impact on FDA activities. We identify key issues and concerns emanating from Washington policymaking that pharmaceutical manufacturers should consider in the coming year with respect to FDA and drug approvals and pricing.

For more details, see our Client Alert.