Onshoring: Drugmakers seek enhancements to FDA’s PreCheck program

During a public meeting on onshoring the production of drugs in the US on Tuesday, stakeholders called for improvements to the US Food and Drug Administration’s (FDA) recently launched PreCheck program. They suggested that the program be expanded to include existing facilities, in addition to new ones, and hailed the program for offering a chance at early feedback on manufacturing issues from the agency.

FDA launched the PreCheck program on 7 August with the aim of accelerating the creation of high-priority pharmaceutical manufacturing facilities in the US to enhance the domestic pharmaceutical supply chain. The agency is accepting public comment on the initiative until 30 October. (RELATED: This Week at FDA: PreCheck manufacturing program, new FDA chief counsel, and more, Regulatory Focus 8 August 2025; FDA seeks feedback on ways to bring manufacturing back to the US, Regulatory Focus 15 August 2025)

The program includes a facility readiness phase that allows more frequent communications between FDA and manufacturers during the drug development stage and an application submission phase that streamlines the chemistry, manufacturing, and controls (CMC) part of premarket applications by facilitating pre-application meetings and allowing early feedback.

Michael Kopcha, the director of the Office of Pharmaceutical Quality (OPQ), expressed concerns about the dangers of excessive dependence on foreign drug manufacturing for medications in the United States during the meeting.

Citing OPQ’s latest Report on the State of Pharmaceutical Quality, Kopcha said, “The data sends a clear message. Most of the 4,619 manufacturing sites listed in CDER’s catalog are located abroad … Over the past five years, the number of foreign manufacturing sites has grown at an accelerated rate. While US sites have increased by 7%, sites in India have grown by 18%, and those in China have expanded by 27%.”

“The concentration of critical manufacturing overseas creates vulnerabilities that we must consider. That’s the reason for this program and why we are meeting today,” Kopcha said.

He further noted that “the core feature of PreCheck is proactive engagement before facilities become operational … Rather than waiting until a facility is built and ready to submit application, we are willing to meeting with manufacturers early on in the design phase.”

Expand Pre-Check to existing facilities

Many stakeholders at the meeting suggested expanding the PreCheck program to include existing facilities, as well as new ones.

Peter Qiu, external advocacy lead for China from Roche Genentech suggested FDA consider expanding the program to existing facilities to quickly shift manufacturing to the US.

Lisa Wright of Novo Nordisk noted that her company has already invested billions of dollars in US manufacturing. “How will this work for facilities that are already constructed?” she asked.

Other participants concurred, with one suggesting that the program be expanded to cover manufacturing changes, such as different types of packaging or alternate container materials, or new manufacturing technologies that are rolled out at existing US facilities.

Lucy Chang, associate vice president of global regulatory affairs CMC biologics at Merck, suggested expanding PreCheck to contract manufacturer organizations (CMOs).

“Merck has already invested $1 billion in domestic manufacturing. Additionally, I want to remind everyone that we are using a CMO, and we should leverage the existing capacity of the CMOs.”

‘Quick and informal’ communication a huge benefit

Jamie Gamerman, head of US regulatory policy at UCB, said that she appreciates the program’s emphasis on early and frequent communications.

“We appreciate the emphasis on quick and informal feedback; this will be a critical part of the program for us to have that real time exchange of information. We also want to add that having the same representatives from the FDA dedicated to the project will be helpful rather than having a couple of different people from FDA who may have a different view of things.”

Onshoring: Drugmakers seek enhancements to FDA’s PreCheck program

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