Former President Donald Trump has signed an executive order aimed at increasing the domestic manufacturing of prescription drugs in the United States. The order is part of a broader effort to reduce dependence on foreign pharmaceutical supply chains and comes ahead of a potential announcement of new tariffs on imported medicines.
The executive order instructs the Food and Drug Administration (FDA) to fast-track the approval of new U.S. drug manufacturing facilities by eliminating unnecessary requirements and streamlining reviews. It also directs the FDA to increase inspection fees for foreign plants and replace scheduled inspections with more unannounced visits to overseas manufacturing sites. The Environmental Protection Agency (EPA) has been directed to accelerate permitting for domestic production of active pharmaceutical ingredients and other key materials.
According to CNBC, the White House said the U.S. currently takes five to ten years to build new pharmaceutical manufacturing capacity, a timeline that is “unacceptable from a national-security standpoint.” CNBC quoted Trump from a White House fact sheet stating, “We don’t want to be buying our pharmaceuticals from other countries because if we’re in a war, we’re in a problem, we want to be able to make our own. 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.”
FDA Commissioner Marty Makary said the order would help the agency conduct more inspections without needing additional resources. He pointed out that foreign plants are often inspected less rigorously than U.S. facilities, and the order seeks to level the playing field.
The order also directs federal agencies involved in permitting pharmaceutical manufacturing to assign a single point of contact to coordinate the process with the White House Office of Management and Budget.
Trump said a “big announcement” about pharmaceutical-specific tariffs is expected within the next two weeks. This comes after the administration launched a Section 232 investigation in April into whether the reliance on pharmaceutical imports poses a national security risk.
Major pharmaceutical companies, including Eli Lilly, Johnson & Johnson, and AbbVie, are already investing in domestic manufacturing. However, Pfizer CEO Albert Bourla recently warned that the threat of tariffs is discouraging further investment in U.S.-based operations.
As reported by NTD, the executive order acknowledges that building new pharmaceutical manufacturing capacity can take up to a decade, and even updating existing lines requires extensive permitting and approvals. NTD noted, “Industry estimates suggest that building new manufacturing capacity for pharmaceuticals and critical inputs may take as long as five to 10 years, which is unacceptable from a national security standpoint.” The report also emphasized that much of the world’s supply of active pharmaceutical ingredients and key starting materials comes from China, creating long-term risks for the U.S. healthcare system.
Commerce Secretary Howard Lutnick has said that pharmaceutical and semiconductor tariffs will be finalized in the next two months and will not be open to negotiation with other countries.
In 2023, the U.S. imported $203 billion worth of pharmaceutical products, with 73 percent coming from Europe. Experts warn that reshoring could raise drug prices even as it aims to strengthen supply chain security.
Disclaimer: The information presented in this article is based on the most recent available sources. The views expressed are those of the author and do not necessarily reflect the official position of any government agency or pharmaceutical organization.
