President Donald Trump signed an executive order aimed at revitalizing pharmaceutical manufacturing within the United States. The move comes amid growing concerns over dependency on foreign sources for critical medical supplies and drugs. The order directs the Food and Drug Administration to expedite approval processes for domestic manufacturing plants by cutting unnecessary requirements and streamlining reviews. It also mandates early FDA engagement with U.S. drugmakers to support facilities before they become operational.
Additionally, the order calls for higher inspection fees for foreign manufacturing sites and more stringent enforcement of reporting on active ingredient sources from overseas producers. Non-compliant facilities may be publicly identified. According to the White House, constructing new pharmaceutical manufacturing infrastructure currently takes between five to ten years—a delay described as unacceptable from a national security standpoint.
Trump emphasized that relying on foreign countries for essential medicines is a strategic risk, especially in times of conflict. He reaffirmed his administration’s commitment to reshoring medical supply chains to safeguard public health and national security. Under the new directive, the FDA will increase inspections of new domestic facilities using existing resources and will also expand unannounced inspections of foreign drug producers.
The Environmental Protection Agency has been tasked with expediting the construction of pharmaceutical manufacturing facilities. Furthermore, all federal permitting agencies must now designate a single point of contact to assist companies through the application process, with oversight from the Office of Management and Budget.
These actions come ahead of expected pharmaceutical-specific tariffs, which Trump said he will announce within two weeks. In April, his administration launched a Section 232 investigation to assess whether pharmaceutical imports compromise national security—a move often seen as a precursor to tariffs.
Major drugmakers including Eli Lilly, Johnson & Johnson, and AbbVie have already begun increasing domestic investment in anticipation of the policy shift. However, not all industry players are on board. Pfizer CEO Albert Bourla recently stated that the threat of tariffs is discouraging the company from investing further in U.S.-based research and manufacturing.
The U.S. pharmaceutical manufacturing base has declined in recent decades, with most active ingredients now produced overseas, particularly in China, due to lower labor and production costs. In 2023 alone, the U.S. imported $203 billion in pharmaceuticals, with 73% coming from European countries. While reshoring production may reduce supply chain vulnerabilities, analysts warn it could also lead to higher drug prices and raise concerns over affordability.
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