In line with the Trump administration’s goal to curb the U.S.’ reliance on overseas drug manufacturing, the FDA has deployed a new program designed to take some of the headache out of setting up domestic plants.
The new FDA PreCheck program will leverage a two-phase approach to help ease the introduction of new pharmaceutical manufacturing facilities in the U.S., according to an Aug. 7 press release.
Under the first stage of the program, which the FDA has dubbed the Facility Readiness Phase, manufacturers will be able to engage more frequently with the regulator “at critical development stages” like facility design, construction and pre-construction.
During this stage, companies will be encouraged to provide comprehensive information on their proposed production sites, including layouts and quality control considerations, the FDA said.
The FDA suggests drugmakers provide this information through a facility-specific Drug Master File, which could later be used to support drug approval applications.
The second phase of the program is focused on streamlining the chemistry, manufacturing and controls portion of a company’s facility application, which the FDA hopes to accomplish via “pre-application meetings and early feedback.”
“Our gradual overreliance on foreign drug manufacturing has created national security risks,” FDA Commissioner Marty Makary, M.D., said in a statement. “The FDA PreCheck initiative is one of many steps FDA is taking that can help reverse America's reliance on foreign drug manufacturing and ensure that Americans have a resilient, strong, and domestic drug supply.”
The FDA will host a public meeting Sept. 30 to discuss the PreCheck program in greater detail and solicit feedback about current onshoring hurdles.
Bringing more manufacturing to the U.S. has been a major facet of President Donald Trump’s trade policy in his second term, with the threat of pharmaceutical import tariffs already prompting a slew of major investment announcements from the life sciences realm.
Meanwhile, the FDA PreCheck program comes as a direct response to Trump’s May executive order calling on the agency to reduce regulatory hurdles for domestic drug manufacturers.
The order specifically asked the FDA to “reduce the amount of time it takes to approve domestic pharmaceutical manufacturing plants” while also increasing fees for and inspections of foreign production sites.
The executive order and the new PreCheck program lack concrete details about how abbreviated facility approval processes will work in practice, but they do indicate that the administration is aware of at least one of the major hurdles when it comes to onshoring manufacturing.
Namely, setting up manufacturing facilities is typically a yearslong process. During the early days of Trump’s second term, industry watchers argued the policy environment in the U.S. would need to shift dramatically to support the rapid, widespread manufacturing build-out that the administration had hoped to see.
Still, the cudgel of import tariffs has already persuaded many pharma companies to make billion-dollar investment pledges in the U.S.
The largest outlay has come courtesy of Johnson & Johnson, which has pledged to infuse $55 billion into its U.S. operations. AstraZeneca and Roche have each earmarked $50 billion in U.S. investments, while Eli Lilly has thrown down $27 billion.
Apart from branded drugmakers, generics and biosimilars manufacturers such as India’s Aurobindo, Korea’s Celltrion and the U.K.’s Hikma Pharmaceuticals are also getting in on the action by moving to grow their U.S. footprints.
As for where Trump’s tariffs currently stand, pharmaceuticals and other products entering the U.S. from Europe will soon be subject to a 15% import tax under a new trade deal struck in late July between the U.S. and the EU.
Separately, the U.S. is expected to share the results of a Section 232 investigation into the national security implications of pharmaceutical imports some time this month, which could prompt industry-specific drug tariffs.
Trump has suggested those duties could be steep, even as the timing of their implementation remains uncertain.
“We’ll be putting initially a small tariff on pharmaceuticals, but in one year—one and a half years maximum—it’s going to go to 150% and then it’s going to go to 250%,” Trump said in an interview with CNBC earlier this week.
He warned that the new sectoral tariff rate would be announced “within the next week or so.”