Over the past several years, U.S. drug manufacturing policy has shifted toward encouraging domestic production of pharmaceuticals and critical components. Supply chain disruptions, geopolitical risk, and quality concerns associated with overseas manufacturing have converged with a renewed federal focus on resiliency, creating both opportunities and regulatory considerations for manufacturers evaluating onshoring or reshoring strategies.

Amplifying this shift has been the Trump Administration's emphasis on strengthening domestic manufacturing. In May 2025, the administration issued an Executive Order titled "Regulatory Relief to Promote Domestic Production of Critical Medicines," representing a significant Federal policy signal in support of U.S.-based pharmaceutical manufacturing. The Reshoring Manufacturing EO directs multiple agencies, including the U.S. Food and Drug Administration (FDA), to reduce regulatory barriers, accelerate review timelines, and increase predictability for companies building or expanding domestic drug manufacturing facilities. FDA is specifically tasked with eliminating duplicative or unnecessary requirements, maximizing review predictability, and expanding early engagement mechanisms that provide technical input before facilities become operational. In parallel, other Federal agencies such as the EPA are directed to streamline permitting and approvals, supported by enhanced interagency coordination through the Office of Management and Budget.

For years, FDA has also been urging drug manufacturers to establish risk management plans to reduce shortages – and increasing U.S. manufacturing is one way for a company to show FDA it is managing shortage risks. Building on these priorities, FDA has advanced a more concrete initiative aimed at improving regulatory transparency for domestic manufacturing: FDA PreCheck. First announced in August 2025, PreCheck is a voluntary program intended to strengthen the U.S. pharmaceutical supply chain by promoting earlier FDA engagement during facility development and application preparation.

In late 2025, FDA convened a public workshop to solicit stakeholder feedback on the PreCheck framework. Industry participants broadly welcomed the program as a means to de-risk U.S. manufacturing investments, while emphasizing the need for clarity around eligibility, integration with existing regulatory pathways, and meaningful incentives. Following this feedback, FDA released a PreCheck implementation roadmap, announcing that applications will open on 1 February 2026, with initial facilities selected based on national priorities such as product type, facility innovations, and time to market.

Despite these developments, onshoring remains a capital- and time-intensive undertaking. For manufacturers considering onshoring or reshoring investments, these developments have implications across the facility lifecycle – from feasibility and site selection through design, construction, regulatory planning, inspection, and product approval – that require careful regulatory planning. Success will depend not only on leveraging PreCheck for early dialogue, but also on embedding quality management maturity principles, inspection readiness, and robust CMC planning into project timelines. As PreCheck moves into implementation in 2026 and beyond, companies should monitor evolving FDA expectations, prepare for early engagement, and align legal, regulatory, quality, and operations teams to manage risk and position domestic manufacturing investments for long-term success.