The program will allow for frequent communication with the FDA, giving manufacturers timely input and guidance regarding the design of their facilities.
In line with the Trump administration’s push to boost the U.S.’s domestic drug supply chain, the FDA began accepting applications for its PreCheck pilot program Sunday, looking to help companies construct their manufacturing plants in the country.
Companies using the PreCheck program will be able to communicate with the FDA more frequently at critical stages of their facility construction, receiving guidance on things like site design and pre-production. Through the program, the regulator will also help guide applications with the Chemistry, Manufacturing and Controls section of their applications.
Applications for potential participants have been opened, according to the agency’s press release.
Commissioner Marty Makary called PreCheck “one of several powerful incentives” that the agency is leveraging to redomicile drug production, in the agency’s statement.
The regulator will select its first batch of facilities based on how well applications align with certain national priorities, including innovation, producing critical medicines for domestic need and timeline for production. The FDA hasn’t yet provided a specific timeline for starting the program nor has it indicated how many program participants it expects to accept, though PreCheck is slated to begin sometime this year
Manufacturers and contract researchers across the U.S. have been looking forward to the PreCheck program, which many say could help them attract more pharma clients.
In an interview with BioSpace last month, Christopher Shilling, chief regulatory officer at gene therapy service provider Forge Biologics, said the FDA often doesn’t visit manufacturing plants until deep into the production process—and years after a facility has been constructed. Manufacturers often don’t have enough time to address the issues that arise during this time.
PreCheck will allow for timely feedback from the FDA very early on in the process, when plants are still under construction, preventing otherwise costly design flaws—and giving both manufacturers and their biopharma clients the knowledge that a plant fits regulatory requirements.
The PreCheck pilot comes as many of the biggest pharma companies pledge billions of dollars to boost their U.S. manufacturing operations. Recently, for example, AbbVie announced a $100 billion package to be doled out over the next 10 years—by far the biggest production pledge so far. Other hefty investments include Johnson & Johnson’s $55 billion promise and AstraZeneca’s $50 billion commitment.
