US president Donald Trump signed an executive order on Monday to accelerate drug manufacturing in the US.
The order seeks to streamline the regulatory approval process for pharmaceutical plants, cutting red tape and encouraging companies to expand or relocate their production operations domestically.
The executive action comes as the Trump administration escalates its pressure on the pharmaceutical industry to reduce reliance on foreign drug manufacturing, particularly from China and India.
“Our nation’s health security should never be held hostage by foreign supply chains,” Trump said during the signing. “With this executive order, we’re taking critical steps to bring drug manufacturing back home, ensure faster approvals and secure a reliable supply of essential medicines for American families.”
The executive order instructs the FDA to “prioritize” reviews and approvals for domestic pharmaceutical facilities by “eliminating duplicative and unnecessary requirements, streamlining reviews and working with domestic manufacturers to provide early support before facilities come online.”
The order also directs the agency to “increase fees for and inspections of foreign manufacturing plants,” as well as “improve enforcement of active pharmaceutical ingredient source reporting by foreign drug producers.” This would include the possibility of publicly displaying a list of facilities that are not compliant.
Related: Eli Lilly Announces $27B Investment to Boost US Manufacturing
Additionally, it directs the EPA to fast-track construction permits for drug production facilities and ensures federal agencies coordinate approvals through a single point of contact for more efficient processing.
According to Reuters, industry analysts and companies estimate that building a new manufacturing plant could take at least five years.
The White House stated that this timeline was “unacceptable from a national-security standpoint.”
Citing such national security concerns, Trump has repeatedly floated the idea of imposing tariffs on pharmaceutical imports, though the sector has long been shielded from such levies due to fears of drug shortages and patient harm.
Trump said he will make an announcement on tariffs on pharmaceutical imports in the next two weeks.
If Trump moves forward with his plans, the pharmaceutical industry could risk significant disruption, as the US imports more than $200 billion in prescription drugs.
According to Reuters, a report by Ernst & Young commissioned by the Pharmaceutical Research and Manufacturers of America (PhRMA) — the main pharma industry lobby group in the US — a 25% US tariff on pharmaceutical imports would drive up drug costs in the country by almost $51 billion a year.
If costs are passed on, this could raise prices by as much as 12.9%.
The executive order aligns with broader US efforts to bolster domestic manufacturing across critical sectors.
To prepare for potential tariffs, major pharmaceutical companies like Bristol Myers Squibb and Gilead Sciences announced multi-billion-dollar investments in their US operations this week.
Analysts suggest Trump’s move towards domestic drug manufacturing could reshape the landscape of pharmaceutical production over the next decade, potentially driving innovation and reducing dependency on international supply chains.
However, they also warn that reshoring efforts must balance speed with safety, ensuring that US patients continue to have uninterrupted access to life-saving medications.
The pharma industry is the latest industry to be put under the microscope in Trump’s America-first agenda.
The executive order states that it is a part of Trump “delivering on his promise to once again put America first by ensuring the FDA prioritizes American manufacturing facilities over foreign facilities.”
“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,” Trump said in the statement.
“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.”
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