Senators Mike Braun (R-Ind.) and Senator Joni Ernst (R-Iowa) on Friday introduced the Creating Efficiency in Foreign Inspections Act, which would eliminate the lead time that foreign pharmaceutical manufacturing facilities receive before FDA inspections to even the playing field between foreign and domestic manufacturers.
Braun
This legislation would create an incentive for drug manufacturers abroad to bring their facilities back to the U.S., which Senators say will lead to a stronger domestic supply chain.
“The COVID-19 pandemic has exposed vulnerabilities in our supply chain and has forced us to reevaluate our reliance on foreign countries for the production of critical drugs,” Sen. Braun said. “The Creating Efficiency in Foreign Inspections Act will help bring drug manufacturing back to the U.S. to create a more reliable and robust pharmaceutical supply chain for the benefit of American patients.”
Background
Foreign pharmaceutical facilities are awarded significant lead time between the time they’re notified of a facility inspection and the time the inspections take place. Domestic facilities don’t receive the same treatment, receiving little to no advance notice prior to a facility inspection. This legislation would end the lead time that pharmaceutical facilities outside of the U.S. receive for FDA inspections and level the playing field for domestic manufacturers.