The Trump administration recently added to an ongoing push to boost pharmaceutical manufacturing in the U.S., launching a new program dubbed PreCheck that aims to ease the process of bringing domestic facilities online.
Using a two-phase approach, the program offers drug companies more frequent communication with the agency in early stages and streamlines development through pre-application meetings and early feedback in “the chemistry, manufacturing and controls section of the application,” the FDA said in its Aug. 7 announcement.
PreCheck is the latest move from the Trump administration to reduce overseas reliance on drugs, stemming from an executive order in May directing the FDA to reduce regulatory barriers for new facilities. It takes between five and 10 years to build out a new pharma manufacturing facility and receive approval, according to the White House, a timeline President Trump called “unacceptable from a national security standpoint” in his executive order. According to the FDA, PreCheck will “maximize” review times and improve predictability in the process.
The program is yet another lever being pulled by the administration to boost manufacturing stateside. It’s also not the first attempt to speed up review times — the FDA also proposed a voucher program earlier this year to quicken the evaluation of certain drugs. The agency, which is operating with a reduced workforce, said it will hold a public meeting to discuss the framework of the program and answer stakeholders’ questions Sept. 30.
Here’s how the program fits into the broader push for U.S. manufacturing.
Incoming tariffs
Over the last few weeks, Trump has been steadfast that he will implement tariffs on the pharmaceutical industry, recently claiming he will initiate a small levy before pushing fees up to 180% in 18 months and eventually reaching 250%. The move is mean to further incentivize a U.S.-based drug supply.
But even if the industry constructs U.S. manufacturing facilities at a speedier pace, tariffs could still make drugs more expensive. Drugmakers could face up to $19 billion in added costs for a 15% tariff, analysts told Reuters in late July. That’s because the U.S. imports the majority of its drug and active pharmaceutical ingredients from overseas.
On the same day the FDA announced the PreCheck program, the agency’s Center for Drug Evaluation and Research also released a report detailing trends about U.S. drug manufacturing and supply.
According ot that report, only 41% of drug manufacturing sites regulated by the FDA are located in the U.S., and more factories are being built overseas than within the country. The number of U.S. sites increased 7% over the last five years, for example, compared to a 27% spike in China and 18% in India.
The pharma industry has opposed levies.
“Tariffs on the biopharmaceutical industry would threaten continued investment and medical progress,” the lobbying group PhRMA said in a statement in May, calling them “counterproductive to the Administration’s goal of bolstering American industry.”
Trump has yet to release details about the incoming pharma tariffs, and so far the industry has dodged the levies that have already been imposed on other industries.
Manufacturing announcements
In the meantime, several pharmaceutical companies have rushed to shore up U.S. manufacturing to lower future tariff costs.
In just the last few weeks alone, AstraZeneca, Biogen and Thermo Fisher have announced investments for new facilities in North Carolina and Virginia. And Eli Lilly, Johnson & Johnson and Roche, among others, have promised billions of dollars in investments to expand their U.S. manufacturing capabilities.
Earlier this year, Lilly said it would spend an additional $27 billion on new U.S. manufacturing, bringing its total amount to $50 billion over five years. J&J’s total spend is expected to reach $55 billion over the next four years, while Roche is also investing $50 billion. The PreCheck program could aid in the construction of the new facilities involved in those investments.
