Trump executive order aims to reshore US drug production

President Donald J. Trump has signed an executive order that seeks to do what past presidents, including Trump himself in his previous administration, did not succeed in doing: increasing US production of drugs and pharmaceutical ingredients.

The order, signed May 5, intends to lower regulatory barriers for companies looking to expand or set up new drug manufacturing facilities in the US. It directs the Food and Drug Administration and the Environmental Protection Agency to take steps to reduce the time it takes to approve new US plants for active pharmaceutical ingredients, key starting materials, and raw materials.

The order refers to industry estimates that building new manufacturing capacity for pharmaceuticals and critical inputs may take as long as 5–10 years, which it calls “unacceptable from a national security standpoint.”

The order directs the FDA and EPA to eliminate “duplicative or unnecessary requirements.” It also mandates that the FDA streamline facility inspection routines and work with “domestic manufacturers to provide support before facilities start functioning.”

At the same time, it instructs the FDA to ramp up inspections of foreign plants that supply ingredients and raw materials to the US. These facilities are inspected less frequently than those in the US, the order says.

The move comes at a time when Trump has repeatedly threatened tariffs on imported pharmaceutical products.

This isn’t the first time a US president has pushed for more domestic manufacturing of medicines and active pharmaceutical ingredients (APIs). For example, in 2020, during the first Trump administration, the federal government handed a $354 million contract to the start-up Phlow to manufacture drugs at risk of shortage, including therapies for COVID-19. Former President Joe Biden’s administration made similar moves.

But those efforts didn't significantly move the needle on US drug manufacturing. A 2023 report by the Atlantic Council, a think tank, found that US imports of Chinese pharmaceutical products continued to grow between 2020 and 2022.

In recent months, several big pharma companies, including Eli Lilly and Company and Novartis, have announced significant investments to expand their production capabilities in the US. But the drugs these companies make are mostly branded or patented medicines, which account for a small fraction of prescription drugs. Around 90% of the prescription drugs needed in the US are generics, and there is domestic manufacturing capacity sitting idle that could be used to make them, says Kevin Webb, chief operating officer of the API Innovation Center, a nonprofit dedicated to increasing US drug manufacturing.

Webb calls the executive order a move in the right direction, saying that it will encourage the commercial sector to commit to building new manufacturing sites in the US. “The order clearly addresses the regulatory hurdles that industry faces, whether it be generics or branded pharmaceuticals,” he says.