‘Over-reliance’ on foreign drug makers carries national security risks, agency says.
The U.S. Food and Drug Administration announced Thursday it is launching the “FDA PreCheck” program in order to help construct drug manufacturing sites in the United States.
“Our gradual over-reliance on foreign drug manufacturing has created national security risks,” said FDA Commissioner Marty Makary in a press release. “The FDA PreCheck initiative is one of many steps [the] FDA is taking that can help reverse America’s reliance on foreign drug manufacturing and ensure that Americans have a resilient, strong, and domestic drug supply.”
According to the release, over half the pharmaceuticals distributed within the United States are manufactured overseas, and active pharmaceutical ingredients, or APIs, are mostly procured from foreign sources.
The PreCheck program will encourage creation of new American drug manufacturing facilities by widening the ability for medicine makers to communicate with the FDA, and by shortening the Chemistry, Manufacturing, and Controls sections of applications for sales and marketing of new drugs.
