Key Points:
- The FDA began accepting applications for its PreCheck manufacturing pilot on Sunday.
- The program aims to accelerate the construction of U.S. drug factories. Facilities producing critical medications will receive priority consideration.
- A two-phase system will allow builders frequent communication with FDA officials.
- A separate fast-track program for drug approval faces delays over safety concerns.
The U.S. Food and Drug Administration (FDA) officially opened the doors on Sunday for its new PreCheck pilot program. This initiative aims to fix a major problem: the slow pace of building and approving new drug factories within the United States. By cutting through red tape and streamlining reviews, the agency hopes to boost the domestic supply of American-made medicines.
This move follows an executive order from President Donald Trump back in May, which demanded a shift in pharmaceutical manufacturing back to U.S. soil.
The FDA plans to pick a select group of new facilities this year to test the program. They are looking for projects that match national priorities, specifically those that can develop products quickly and use innovative building methods. Factories that plan to make “critical medications” for American patients will jump to the front of the line.
The PreCheck program uses a two-step system to speed things up. In the first phase, drugmakers will get to talk to the FDA much more often than usual. They can discuss facility designs and construction plans before they even lay the foundation. In the second phase, the agency will offer early feedback on how the factories handle manufacturing and quality control. The goal is to catch problems early so companies do not waste time fixing them later during the formal application process.
This isn’t the only way the government is trying to rush new drugs to market. In June, the FDA launched a separate “National Priority Voucher Program” promising approval decisions in just one or two months for vital drugs.
However, that program has hit some speed bumps. Recent reports show that agency scientists delayed reviews for two drugs in that fast-track lane due to serious safety worries, including a patient death.
Despite those hiccups with the voucher system, the administration is pressing forward with PreCheck to ensure the U.S. relies less on foreign factories for its essential medicine cabinet.
