Washington, D.C. — President Donald Trump signed an executive order on Monday aimed at bolstering domestic pharmaceutical manufacturing. The initiative seeks to ease the approval process for U.S. production facilities as the administration considers implementing tariffs on imported drugs.
The order mandates the Food and Drug Administration (FDA) to expedite the approval timeline for new manufacturing plants by eliminating regulations deemed unnecessary and streamlining the review process. It also emphasizes early support for domestic drugmakers in facilitating new operations. According to the White House, the current timeline for establishing manufacturing capacity can take between five to ten years, which officials label as problematic from a national security perspective.
Trump expressed his concerns regarding reliance on foreign pharmaceutical supplies, stating, “We want to be able to make our own.” He highlighted the importance of reinforcing the nation’s medical supply chains and emphasized the move to produce pharmaceuticals and medical supplies within the U.S.
Alongside the new manufacturing incentives, the FDA is tasked with increasing inspections of foreign manufacturing plants, shifting from scheduled to unannounced visits. FDA Commissioner Marty Makary pointed out the discrepancy in inspection processes, noting that domestic manufacturers face rigorous scrutiny while foreign facilities benefit from pre-arranged inspections.
The executive order also instructs the Environmental Protection Agency to facilitate the establishment of pharmaceutical manufacturing sites and ensures that federal agencies streamline permit applications through a designated point of contact. This move reflects a broader effort to stimulate domestic investment in drug production amid planned tariffs on imported pharmaceuticals.
The proposed tariffs, which Trump plans to announce within two weeks, are tied to a recent investigation into how pharmaceutical imports impact national security. The investigation is seen as a precursor to the imposition of levies aimed at increasing costs for foreign-made drugs.
While some pharmaceutical companies have welcomed the potential for increased domestic manufacturing, others, like Pfizer, have voiced concerns. CEO Albert Bourla indicated that the tariff threats may hinder further investments in research and development within the U.S.
The pharmaceutical industry has witnessed a significant decline in domestic manufacturing over the past few decades, with many active ingredients now sourced from lower-cost countries, particularly in Asia. In 2023 alone, the U.S. imported over $203 billion in pharmaceutical products, with the majority coming from European nations, particularly Ireland, Germany, and Switzerland.
Industry analysts suggest that reshoring manufacturing could enhance the resilience of the drug supply chain, decreasing vulnerabilities to disruptions. However, there are concerns that such shifts might lead to increased production costs and higher drug prices, thereby impacting affordability.
As this landscape evolves, the balance between bolstering national manufacturing capacities and ensuring accessible healthcare will be crucial, with stakeholders closely monitoring the implications of the executive order and forthcoming tariff decisions.