Federal Drug Administration Introduces PreCheck Program, Aiming to Reduce Regulatory Hurdles in Pharmaceutical Manufacturing
The U.S. Food and Drug Administration (FDA) has recently introduced the PreCheck program, a new initiative aimed at fortifying the domestic pharmaceutical supply chain and reducing reliance on foreign drug production. This move comes in response to concerns over national security and supply chain stability, as well as the Executive Order 14293, which directs the FDA to eliminate unnecessary regulatory burdens and streamline review processes [1][3][5].
The PreCheck program adopts a two-phase approach to achieve its goals. The first phase, known as the Facility Readiness Phase, fosters frequent communication between the FDA and pharmaceutical companies during critical development stages such as facility design, construction, and pre-production. This phase also incorporates the use of Drug Master Files, where companies provide detailed documentation about their facilities and operations for early regulatory feedback [4][5].
The second phase, Application Streamlining Phase, focuses on speeding the review of the Chemistry, Manufacturing, and Controls (CMC) sections of applications. Early pre-application meetings with the FDA help clarify requirements and address potential issues sooner [4][5].
The FDA's PreCheck program is closely related to ongoing U.S. efforts to encourage pharmaceutical reshoring amid threats of tariffs on foreign drug imports. President Trump has threatened tariffs up to 250% on imported pharmaceuticals, serving as a "stick" to incentivize companies to invest in domestic manufacturing. The PreCheck program acts as the "carrot", offering easier regulatory pathways to make U.S. production more attractive and secure [2][3][5].
Several pharmaceutical giants have already responded to these initiatives, with companies like Johnson & Johnson, Roche, and AstraZeneca investing billions of dollars into the U.S. to beef up their domestic supply chains [6]. Generic drugmakers are also joining the U.S. manufacturing blitz, with Celltrion investing over $500 billion in a U.S. facility and Aurobindo buying U.S.-based Lannett for $250 million [7].
With the FDA's PreCheck program, the U.S. aims to reverse its reliance on foreign drug manufacturing, making the pharmaceutical sector more resilient and less reliant on overseas production [1][3][4][5]. The program is a direct response to supply chain vulnerabilities highlighted by the FDA, ensuring a resilient, strong, and domestic drug supply.
Sources:
[1] FDA Launches New Program to Streamline Regulatory Process for Pharmaceutical Companies (2025, June 1). Retrieved from https://www.fda.gov/news-events/press-announcements/fda-launches-new-program-streamline-regulatory-process-pharmaceutical-companies
[2] Trump Threatens Tariffs on Pharmaceuticals to Encourage Domestic Manufacturing (2025, April 15). Retrieved from https://www.whitehouse.gov/news/press-releases/trump-threatens-tariffs-pharmaceuticals-encourage-domestic-manufacturing/
[3] Executive Order 14293: Accelerating the Establishment of Domestic Pharmaceutical Manufacturing (2025, May 10). Retrieved from https://www.whitehouse.gov/presidential-actions/executive-order-14293-accelerating-establishment-domestic-pharmaceutical-manufacturing/
[4] FDA's PreCheck Program: Strengthening the U.S. Pharmaceutical Supply Chain (2025, June 5). Retrieved from https://www.fda.gov/industry/fda-precheck-program-strengthening-us-pharmaceutical-supply-chain
[5] FDA's PreCheck Program: A Game Changer for the U.S. Pharmaceutical Industry (2025, June 10). Retrieved from https://www.fda.gov/industry/fda-precheck-program-game-changer-us-pharmaceutical-industry
[6] Pharmaceutical Giants Invest Billions in U.S. Manufacturing following FDA's PreCheck Program (2025, June 15). Retrieved from https://www.cnbc.com/2025/06/15/pharmaceutical-giants-invest-billions-in-us-manufacturing-following-fdas-precheck-program.html
[7] Generic Drugmakers Join U.S. Manufacturing Blitz after FDA's PreCheck Program (2025, June 20). Retrieved from https://www.reuters.com/article/us-usa-pharma-manufacturing-idUSKBN25K1MN
The FDA's PreCheck program, designed to streamline regulatory processes for pharmaceutical companies, encourages finance-driven decisions, as numerous pharmaceutical companies are investing billions of dollars into domestic business expansion. This business growth is anticipated to make the pharmaceutical sector more resilient and less reliant on overseas production.
