FDA Launches 7-Firm PreCheck Pilot to Speed U.S. Drug Plants as 70% of Facilities Sit Abroad
Updated
Updated · Fox News · Jul 22
FDA Launches 7-Firm PreCheck Pilot to Speed U.S. Drug Plants as 70% of Facilities Sit Abroad
3 articles · Updated · Fox News · Jul 22
Summary
Seven companies including Eli Lilly, Regeneron and Amneal have joined the FDA’s new PreCheck pilot, which the agency says will help new U.S. drug plants break ground and scale operations this summer.
The two-phase program gives manufacturers early technical feedback and enhanced application support, aiming to avoid compliance mistakes and shorten reviews that officials say can leave completed facilities idle for up to 14 months.
FDA said the first seven participants are building facilities for products ranging from cell and gene therapies to IV bags, with the projects expected to support thousands of long-term, high-wage jobs and thousands more near-term positions.
The push follows Trump’s Executive Order 14293 and comes as more than 70% of primary manufacturing facilities for U.S. prescriptions remain overseas, a dependence the agency says has increased shortage and national-security risks.
FDA said it is also drafting rules for distributed manufacturing, increasing transparency on foreign suppliers and prioritizing some domestically sourced generic-drug applications; generics account for about 90% of U.S. prescriptions.