Premier Weighs in on FDA’s Pre-Check Program to Accelerate Domestic Manufacturing

Premier submitted comments to the FDA following the Sept. 30 public meeting discussing the agency's new PreCheck program. FDA's proposal focuses on ways to accelerate the establishment of high priority new pharmaceutical manufacturing facilities in the US and strengthen the domestic pharmaceutical supply chain. Premier's comments support the program which aligns closely with Premier's requests for increased inspections, streamlined regulatory processes and other incentives to increase domestic manufacturing of critical pharmaceutical products and active pharmaceutical ingredients (API).

Specifically, Premier urges FDA to:

• Prioritize pharmaceuticals identified by the FDA and Department of Defense (DoD) as essential medicines pursuant to Presidential Executive Order 13944;
• Ensure the PreCheck Program is applicable to the manufacturing of all components of essential medicines including the finished dose, active pharmaceutical ingredient (API), key starting materials (KSMs) and excipients;
• Expand the scope of the PreCheck Program to also include essential medical devices and their componentry as identified by the FDA and Department of Defense (DoD) pursuant to Presidential Executive Order 13944; and
• Augment supply chain resiliency efforts through additional mechanisms such as tax incentives for domestic manufacturing, the creation of trusted trade partnerships for near shoring, and differential reimbursement and federal purchasing requirements for domestically manufactured medical supplies.

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Premier Comments on FDA's Pre-Check Program