Pharma groups seek expansion of FDA’s PreCheck program

Numerous pharmaceutical industry groups are advocating for the expansion of the US Food and Drug Administration’s (FDA) PreCheck program to cover existing manufacturing facilities, as well as new ones. Additionally, some groups recommend that PreCheck be integrated with current programs. The generic drug industry has also suggested that other government initiatives and support should be implemented to strengthen this sector.

These comments were made in response to the FDA’s request for public input on the PreCheck program, which seeks to encourage pharmaceutical companies to establish new manufacturing facilities in the United States. The program was announced by FDA Commissioner Marty Makary in August 2025. (RELATED: FDA seeks feedback on ways to bring manufacturing back to the US, Regulatory Focus 15 August 2025).

FDA received 74 responses to the guidance. The deadline for submitting comments was 30 October.

Broaden scope of program to include existing facilities

Many stakeholders suggested expanding the PreCheck program to include both existing facilities and new ones. This recommendation was also echoed in a previous public meeting. (RELATED: Onshoring: Drugmakers seek enhancements to FDA’s PreCheck program, Regulatory Focus 30 September 2025).

The Biotechnology Innovation Organization (BIO) said that “expanding eligibility would maximize the program’s impact in the short term and accelerate domestic capacity expansion.”

“The program’s scope could be expanded to include the onshoring or modernization of facilities manufacturing already approved products, facility expansions, and facilities producing essential medicines or implementing advanced manufacturing technologies. These activities are occurring now and quick implementation of the FDA Pre-Check program will ensure that US-based manufacturing grows accordingly assuring supply chain security for the American people,” BIO wrote.

The Bulk Pharmaceuticals Task Force (BPTF) also recommended expanding the program to include existing active pharmaceutical ingredient (API) manufacturing facilities.

“This [expansion] would greatly accelerate the availability of new cGMP capacity, addressing national security concerns potentially in the near term. The term “new” should be broadly defined. BPTF asserts that Quality Culture, that is the cGMP mindset, is most easily expanded at an existing site, rather than newly developed at a greenfield site.”

Similarly, the Association for Accessible Medicines (AAM) recommended that “this guidance should address the program’s applicability not only to new manufacturing facilities, but also to existing or currently dormant facilities and to the repurposing or modernization of manufacturing lines within established sites.”

AAM further noted that “many generic manufacturers already maintain dormant or underutilized U.S. facilities that could be restarted far more quickly than building entirely new plants - if the right economic incentives are in place.”

Generic industry needs additional government support

AAM further said that the generic drug industry needs additional government support, which is beyond FDA’s remit, to prompt onshoring of medicines.

“We believe that broader, more comprehensive solutions will be necessary to encourage and increase domestic manufacturing, strengthen supply-chain resiliency, and safeguard patient access to generic and biosimilar medicines.”

AAM stated there is a “profound economic imbalance” between the brand and generic sectors, highlighting the need for increased government support to boost domestic manufacturing of generic drugs.

The group further noted that “meaningful progress toward the Administration’s onshoring and supply-chain resiliency objectives will require not only clear and robust regulatory incentives, but also complementary economic and policy measures beyond FDA’s remit.”

BIO, ASGCT recommend integrating the program with other initiatives

BIO also suggested integrating PreCheck with complementary modernization efforts, such as the Center for Drug Evaluation and Research's Emerging Technology Team (ETT) and the Center for Biologics Evaluation and Research's Advanced Technologies Team (CATT) to harmonize expectations for advanced manufacturing platforms and digital oversight tools.

The group states that “leveraging these programs would enable data-driven oversight approaches, including predictive analytics and digital-twin modeling, to inform inspection planning and continuous quality monitoring.”

The American Society of Gene & Cell Therapy (ASGCT) said that “linking PreCheck with existing FDA initiatives such as the Advanced Manufacturing Technologies Designation and the Platform Technologies Designation could provide earlier visibility into novel approaches, help derisk their use, and encourage broader adoption across the field.”

PhRMA says reduce the amount of site-specific data for Precheck

PhRMA also suggested that to expedite the process for onshoring pharmaceutical manufacturing, FDA should reduce the amount of site-specific data required from manufacturers participating in the PreCheck program.

Specifically, PhRMA recommended lowering the number of process performance qualification (PPQ) runs and the amount of stability data needed before products can be released for distribution.

PhRMA stated that “each PPQ run typically requires substantial time and cost to complete. In a tightly controlled manufacturing environment operating under a robust quality system and employing modern methods such as analytical technology and in-line monitoring, however, sponsors now have considerably greater insight into product characteristics during manufacture than was once common. As a result, multiple PPQ runs are often unnecessary to establish the capability of a manufacturing process.”

PhRMA also called for the removal of “unnecessary” and “lengthy” stability testing requirements for sites participating in the PreCheck program.

The group stated that FDA has adopted the International Council for Harmonisation’s Q12 guidance on postapproval changes, which specifies that the purpose of stability studies is to support changes in the chemistry, manufacturing, and controls (CMC) after approval, as well as to confirm the previously approved shelf life and storage conditions.

PhRMA indicates that although FDA has formally adopted this guidance, the agency “does not often apply it in practice; rather, FDA generally requires at least 6 months of stability data to support a manufacturing site transfer.”

ASGCT: Concern about confidentiality

The American Society of Gene and Cell Therapy (ASGCT) sought clearer guidelines on how confidentiality rules would operate.

The group states that “there are important concerns about public disclosure under the Freedom of Information Act (FOIA), particularly for innovator companies hesitant to share process or validation data. Clear segregation is needed between facility-level Good Manufacturing Practice (GMP) information and product-specific data, such as validation packages or process performance qualification (PPQ) runs. FDA could also consider allowing supplier data and Letters of Authorization to be referenced within facility DMFs to reduce redundant review across sponsors.”

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Pharma groups seek expansion of FDA’s PreCheck program

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