Trump signs order to spice up U.S. drug manufacturing

President Donald Trump on Monday signed an executive order to incentivize prescription drug manufacturing within the U.S., streamlining the trail for pharmaceutical firms to construct latest production sites stateside as potential tariffs on imported medicines loom.

The order directs the Food and Drug Administration to cut back the period of time it takes to approve manufacturing plants within the U.S. by eliminating unnecessary requirements, streamlining reviews and dealing with domestic drugmakers to “provide early support before facilities come online,” in line with a White House fact sheet.

It also directs the agency to lift inspection fees for foreign manufacturing plants, improve the enforcement of active-ingredient source reporting by overseas producers and consider publicly listing facilities that do not comply.

The White House estimates that it will possibly currently take five to 10 years to construct latest manufacturing capability for pharmaceuticals, which it called “unacceptable from a national-security standpoint.”

“We don’t desire to be buying our pharmaceuticals from other countries because if we’re in a war, we’re in an issue, we would like to have the opportunity to make our own,” Trump said in the actual fact sheet. “As we put money into the long run, we’ll permanently bring our medical supply chains back home. We are going to produce our medical supplies, pharmaceuticals, and coverings right here in the US.”

The order will allow the FDA to conduct more inspections of latest manufacturing sites with the identical resources, the agency’s commissioner, Marty Makary, told reporters on Monday. The FDA can even ramp up inspections of foreign drug facilities, switching from announced to “surprise” visits overseas, he said.

“We had this crazy system in the US where American pharma manufacturers … are put through the ringer with inspections, and the foreign sites get so much easier with scheduled visits, while we’ve got surprise visits,” Makary said.

Trump’s order also directs the Environmental Protection Agency to “speed up the development of facilities” related to manufacturing drugs and their ingredients. And, it ensures that federal agencies issuing permits for a domestic pharmaceutical manufacturing facility designate a single point-of-contact to coordinate applications, together with support from the White House Office of Management and Budget.

The order comes ahead of Trump’s planned tariffs on pharmaceuticals imported into the U.S. Those potential levies – and efforts to construct goodwill with the President – have already fueled a fresh wave of domestic manufacturing investments from drugmakers comparable to Eli Lilly, Johnson & Johnson and AbbVie. 

Trump on Monday told reporters he’ll announce pharmaceutical-specific tariffs inside the following two weeks. His administration disclosed in April that it had opened a so-called Section 232 investigation into how importing certain pharmaceuticals affects national security — a move widely seen as a prelude to initiating tariffs on drugs. 

Some pharmaceutical firms are beginning to beat back on Trump’s plans. For instance, Pfizer CEO Albert Bourla said last week that the tariff threat is deterring the corporate from making further U.S. investments in research and development and manufacturing.

U.S. manufacturing within the pharmaceutical industry has shrunk significantly in recent a long time. Production of many of the so-called lively ingredients in medicines has moved to China and other countries, largely as a consequence of lower costs for labor and other parts of the method, in line with the Food and Drug Administration.

The U.S. imported $203 billion in pharmaceutical products in 2023 alone, with 73% coming from Europe, primarily Ireland, Germany and Switzerland, in line with evaluation conducted by consulting firm EY. 

Reshoring manufacturing will help make the drug supply chain more robust, decreasing the chance of disruptions, in line with an April release from GlobalData, a knowledge and analytics company. Still, it could elevate production costs and drug prices, raising affordability concerns, GlobalData said.