In President Donald Trump’s latest push to bring pharmaceutical manufacturing to the U.S., a new executive order tasks the FDA with reducing regulatory hurdles for domestic producers while making life harder for foreign manufacturers.
The new executive order, signed on Monday, asks the FDA to “reduce the amount of time it takes to approve domestic pharmaceutical manufacturing plants.”
In the meantime, the order directs the FDA to “increase fees for and inspections of foreign manufacturing plants.”
The order lacks details or specific goals, and it’s not entirely clear whether the mandate applies to every FDA inspection or only new facilities, production lines or products. Federal agencies are responsible for designing specific rules following the direction of an executive order.
To benefit domestic manufacturers, Trump is asking the FDA to eliminate “duplicative and unnecessary requirements,” to streamline reviews and to “provide early support before facilities come online.”
New FDA Commissioner Marty Makary, M.D., appears on board with the order and is prepared to act on it.
“We have had this crazy system in the United States where American pharma manufacturers in the United States are put through the wringers with inspections, and the foreign sites get off easy with scheduled visits, while we have surprise visits in the United States,” Makary said during the signing of the executive order at the White House.
Instead, Makary said the FDA will “switch” from announced to surprise visits for overseas drug facility inspections.
Still, the question remains whether the agency has enough resources to conduct those foreign inspections. The FDA has been struggling with a major inspection backlog, especially in foreign countries, since the pandemic. An Associated Press analysis last year found that 160 pharmaceutical plants in India and 185 factories in China were past due for inspection.
Meanwhile, recent mass layoffs at the FDA have affected the agency’s Office of Inspections and Investigations. Even though inspectors themselves were spared, the loss of administrative staff has raised concerns about further delays and disruptions to inspections.
Makary suggested that the FDA will reduce the length of future inspections.
“We’re also not going to have our inspectors hanging out for three to four weeks,” Makary said. “So we’re gonna get in and out, and we’re gonna do more inspections with the same resources as a result.”
Besides the FDA, the Environmental Protection Agency was ordered to accelerate the construction of facilities for the manufacturing of prescription drugs, active pharmaceutical ingredients and other necessary raw materials.
With support from the White House, a single point of contact among federal agencies will coordinate permit applications for domestic pharma manufacturing facilities “to ensure an efficient and coordinated process,” according to the order.
Building new manufacturing capacity for pharmaceuticals and critical inputs can take as long as five to 10 years, “which is unacceptable from a national-security standpoint,” the order reads.
“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 a statement Monday.
The executive order adds on to Trump’s planned tariffs on pharmaceuticals in his overall strategy to onshore production of medicines. At the White House event, Trump told reporters that he will announce pharmaceutical-specific tariffs in the next two weeks.
The Trump administration recently launched what’s known as a Section 232 investigation to examine the national security implications of pharmaceutical imports. Findings from the probe could pave the way for potential tariffs.
Pointing to Trump’s remarks during an April 30 rally, Jefferies analysts noted that pharmaceutical tariffs might be implemented gradually, a mechanism that the pharma industry has been seeking.
“We’re gonna be getting tremendous amounts of drug and pharmaceutical companies pouring into the country […] And we’re going to give them time to do it. After that, there’s going to be a tariff wall put up,” Trump said, as quoted by Jefferies.
“But they’ll be happy about it if they start building right now,” Trump continued. “And after a certain amount of time, it’s gonna get tougher, tougher, tougher.”