Against a backdrop of tariff updates and a drug pricing deal from the Trump administration, the FDA charted a pair of moves this week in its push to make drug manufacturing more attractive in the U.S.
Friday, the regulator unveiled a new pilot prioritization program that aims to speed up approval review times for generic drug makers that test and manufacture their products in the U.S.
Specifically, generics companies that file abbreviated new drug applications that meet the FDA’s domestic production and bioequivalence testing requirements—including the use of “exclusively domestic sources for API”—will become eligible for priority review, the agency explained in an Oct. 3 release.
The pilot program aligns with the onshoring ethos that has defined many of the administration’s pharma-related policy maneuvers this year.
More than half of the pharmaceuticals shipped out across the country are produced overseas, the FDA noted in its release. Meanwhile, as of 2025, just 9% of active pharmaceutical ingredient manufacturers are located in the U.S., compared to 22% in China and 44% in India, according to the agency.
Trials, as well as bioequivalence testing for generic drugs, are also increasingly taking place outside the U.S. in a phenomenon that the FDA warned is “weakening” the country’s pharma R&D infrastructure.
“Overreliance on foreign drug manufacturing and testing creates risks both to national security and patient access, and undermines investments in U.S. research, manufacturing and production,” George Tidmarsh, M.D., Ph.D., director of the FDA’s Center for Drug Evaluation and Research, said in a statement.
He added that the U.S.’ dependence on overseas production “also slows down reviews and costs taxpayers more money, as these foreign research and testing sites must be inspected by FDA, and foreign inspections take more time to prepare for and are more expensive to conduct than domestic inspections.”
While finding locally sourced APIs might be easier said than done, the program does focus on incentivizing production of the drugs that make up the vast majority of the medications patients take in the U.S.
The FDA estimated in 2023 that 91% of all prescriptions in the U.S. were filled with generics, noting at the time that it considered copycat medicines a “significant public health priority.”
As the administration began to flex its tariff muscle in a bid to encourage domestic manufacturing investments earlier this year, concerns mounted that generic drug makers—which operate on much thinner margins than their branded pharma counterparts—might struggle to endure the import taxes on the agenda.
Nevertheless, the final 100% tariff rate that the administration has settled on for pharmaceutical imports seems to only apply to branded drugs. And separate trade deals that President Donald Trump has struck with the EU and Japan exempt generic medicines as well.
FDA PreCheck check-in
Aside from the ANDA pilot, the FDA on Tuesday hosted a public meeting, attended by representatives from multiple drugmakers, to solicit feedback on the facility PreCheck program it unveiled in early August.
The FDA PreCheck program—which the agency has proposed in response to a May executive order to reduce regulatory hurdles for domestic drug manufacturers—broadly aims to improve early engagement between the FDA and the industry during facility build-outs, with the goal to make it easier for new manufacturing plants to come online in the U.S.
At the meeting, the FDA specifically sought feedback from industry stakeholders on the biggest hurdles facing domestic manufacturing, the elements of the proposed PreCheck program likeliest to help set up new U.S. plants and any additional considerations for the agency.
In another key question, the FDA asked companies whether they would be willing to share information on manufacturing facilities prior to or separate from an application submission, which typically triggers production site reviews.
There was “great engagement” and a “good dialogue” between the industry and the FDA at the meeting, though the PreCheck program is certainly still a work in progress, Christopher Shilling, chief regulatory officer at gene therapy CDMO Forge Biologics, said in an interview following the public session.
“There’s no finished product, but still a lot of great opportunity here,” he said.
One key recommendation that was raised during the meeting tied back to the FDA’s final question about providing manufacturing information prior to an application submission, Shilling noted.
“In the current state, facilities aren’t inspected until the market application is submitted, and then you get into the PDUFA time clock—a very restricted and very time-consuming and resource-dependent process that’s been high pressure, and does not leave much wiggle room for remediation if there’s an issue,” Shilling said.
Both the FDA and the companies attending the meeting seemed amenable to the idea of “decoupling” facility reviews from the preapproval process and engaging on manufacturing at an earlier point in time, Shilling noted.
While much of the meeting’s attendance was made up of Big Pharma representatives, CDMOs are poised to benefit from the PreCheck program as well, Shilling noted.
Namely, the program presents an opportunity for contractors to work more directly with the FDA on their production approaches, which hasn’t typically been the case in the past.
“The current state of things is the agency reviews CMOs through the actions of clients, or sponsors or developers,” Shilling explained.
Those clients, sponsors and developers have historically been the ones to submit documentation to the FDA, referencing their CDMOs’ documents and master files or manufacturing processes, while the contract manufacturers have had to “sit a bit off to the side” during the proceedings, he said.
Shilling was optimistic about many of the potential changes under discussion but stressed that “there really needs to be good, clear guidance” when the PreCheck program eventually launches. Given that this program would provide optional perks to manufacturers who meet the requirements, the FDA’s terms for eligibility and how companies can opt in need to be clearly ironed out and communicated.
“I think we’ve still got some time ahead of us before this becomes solidified,” he explained. “So, we’re excited for it; I think it would really benefit us in a number of ways, and we’d like to see it enacted soon. But we’ve got a little bit ahead of us before that.”
During the meeting, industry stakeholders also called on the FDA to include current facilities, in addition to new ones, in the program, the Regulatory Affairs Professionals Society (RAPS) reported earlier this week.
A representative from Roche’s Genentech unit urged the FDA to extend the program to existing manufacturing sites to help quickly pivot production to the U.S., while a Novo Nordisk speaker questioned whether her company’s previous investments in domestic manufacturing would confer PreCheck benefits, according to RAPS.
The FDA is accepting public comments on the PreCheck proposal until Oct. 30, the agency said.