For decades, U.S. policymakers have highlighted the vulnerabilities of relying on foreign supply chains for essential medicines. Yet over 70% of the primary manufacturing facilities for prescriptions filled in the United States remain outside our borders. Over time, a suffocating web of state and federal regulations meant that companies investing millions or billions to build facilities in the U.S. would see those investments sit idle for up to 14 months waiting for standard post-construction reviews. This paralysis has driven supply chains further overseas, hurting the Americans who rely on life-saving cures and treatments.
When critical supply chains are anchored half a world away, American patients are left exposed to dangerous shortages and American workers are stripped of high-paying employment opportunities.
President Donald Trump prioritized solving this problem by signing Executive Order 14293, “Regulatory Relief to Promote Domestic Production of Critical Medicines,” directing the FDA to cut red tape, incentivize domestic manufacturing and secure medicines for American patients. The FDA took that directive urgently. Moving into mid-July, we are aggressively executing on multiple fronts to spark a domestic manufacturing renaissance – removing regulatory roadblocks and creating an environment where American production can outcompete the rest of the world.
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To rev up our domestic pharmaceutical manufacturing base from the ground up, the FDA recently launched the PreCheck Pilot Program. Designed to clear the hurdles that stall new manufacturing facility builds in the U.S., this program is already unleashing a historic wave of domestic job creation, proving we can secure our health while building a powerhouse economy.
The program operates in two distinct phases. In the early Facility Readiness Phase, manufacturers receive technical and regulatory feedback before operations begin, preventing costly compliance mistakes. Next, the Application Submission Phase features enhanced FDA engagement to quickly resolve manufacturing questions, expedite the review of facility information and fast-track inspections.
By identifying potential issues early, the PreCheck program reduces delays, improves regulatory predictability and accelerates the availability of U.S.-manufactured medicines. This ensures next-generation medical breakthroughs are researched, developed and manufactured right here at home by leveraging our greatest resource – the extraordinary talent, grit and might of the American workforce.
Following our selection of the program’s first seven corporate participants – including Eli Lilly, Regeneron, Amneal, Cellares, Fujifilm Biotechnologies, Kriya Therapeutics and Kyowa Kirin – the FDA is actively working alongside these innovators as they break ground and scale operations this summer. These companies are building state-of-the-art facilities to manufacture everything from innovative cell and gene therapies to everyday IV bags.
Crucially, these first seven participants alone will anchor thousands of long-term, high-wage careers for American scientists, engineers, technicians and operators, while instantly fueling thousands of jobs across the heartland.
These are the kinds of stable, family-sustaining careers that anchor communities for generations, helping revitalize local economies and ensuring our brightest minds and hardest workers can build prosperous careers right in their home neighborhoods.
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In addition to this pilot, the FDA is moving forward with newly released draft regulations to streamline pathways for distributed manufacturing and provide greater transparency regarding foreign medicine suppliers. We are also reimagining the incentives within our control.
While the FDA is required to prioritize applications based on urgent public health needs, we are now also prioritizing applications for older, generic medicines that utilize domestic supply chains. These lower-cost medicines make up roughly 90% of all prescriptions written in the U.S., yet they are the very drugs most frequently manufactured overseas. Moving production back home means bringing thousands more stable manufacturing jobs to American factories.
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When a parent goes to the pharmacy for a child’s antibiotic or a patient fights cancer, they should not have to worry about whether a factory closure overseas will cut off their lifeline. Onshoring pharmaceuticals will require a synchronized effort across HHS, private industry and state and local communities, and it is integral to the health, national security and economic prosperity of the American people.
Securing our factories is only one piece of the puzzle; we must also secure the science that feeds them. Under the leadership of President Donald Trump and Secretary Robert F. Kennedy Jr., the Department of Health and Human Services recently launched “Operation TrialBlazer,” a historic initiative designed to bring clinical trials back to American soil by modernizing drug development and slashing regulatory burdens. Making the United States the most attractive place to conduct clinical research ensures that laboratory discoveries translate directly into high-tech production jobs on American soil.
Through the PreCheck program, aggressive regulatory reform and domestic prioritization, the FDA is acting as a collaborative catalyst for domestic growth. We are protecting patients, fueling a high-tech economic renaissance and restoring American independence by putting American workers first.
Source – https://www.foxnews.com/opinion/fda-moves-boosting-american-jobs-protecting-medicine-supply
