Can the FDA Speed Up Drug Factory Construction? Trump’s Order Aims to Make It Happen

U.S. President Donald Trump signed an executive order aimed at accelerating the approval process for domestic pharmaceutical manufacturing facilities. The order instructs the Food and Drug Administration (FDA) to streamline regulatory reviews, remove redundant requirements, and collaborate with domestic manufacturers to offer early support before new plants become operational.

FDA to tighten oversight of foreign drug plants as EPA fast-tracks U.S. facility approvals

The FDA is directed to raise inspection fees for overseas manufacturing sites and enhance enforcement of reporting requirements related to active pharmaceutical ingredient (API) sources. The agency will also evaluate the possibility of publicly listing non-compliant foreign facilities.

Additionally, the executive order tasks the Environmental Protection Agency (EPA) with expediting the development of facilities that produce prescription drugs, active pharmaceutical ingredients, and essential raw materials. To streamline the permitting process, federal agencies involved in authorizing these facilities must assign a single point of contact to coordinate applications. Interagency collaboration, including assistance from the White House Office of Management and Budget (OMB), will support this effort to ensure a more efficient and unified approval process.

The White House described the current lengthy timelines for pharmaceutical production as “unacceptable from a national-security standpoint.” President Trump emphasized the administration’s commitment to domestic production, stating, “As we invest in the future, we will permanently bring our medical supply chains back home. We will produce our medical supplies, pharmaceuticals, and treatments right here in the United States.” 

This move follows recent investigations launched by the administration into imports of pharmaceuticals and semiconductors, citing national security risks linked to heavy dependence on foreign manufacturing. While details regarding potential tariffs remain unclear, Trump indicated he would provide further updates within the next two weeks.

Tariffs and pricing reforms push drugmakers to invest in U.S. production

The Trump administration is applying renewed pressure on the pharmaceutical industry through multiple policy fronts, including tax reform, trade measures, and drug pricing strategies. In response, companies have announced major funding commitments for domestic production facilities in 2025, aiming to strengthen local supply chains. At the same time, the administration is considering broader price control mechanisms that may extend beyond the provisions of the Inflation Reduction Act. President Trump indicated that further details on both tariffs and pricing reforms could be announced within two weeks.

In parallel with regulatory changes, several major pharmaceutical firms, among them Johnson & Johnson, Eli Lilly, Merck & Co., Novartis, and Roche, are supporting efforts to bring drug production back to the U.S., while also seeking to influence policy outcomes. The executive order signed Monday aims to reduce regulatory delays in facility construction and streamline FDA inspections, especially for domestic sites. It also increases oversight of foreign plants supplying the U.S. market. Alex Schriver, representing the industry group PhRMA, welcomed the administration’s support for U.S. investment but warned that tariffs and international pricing models could have the opposite effect by discouraging domestic growth and weakening global competitiveness.

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Author

Denisse Sandoval