WASHINGTON — Today, Senators Mike Braun and Senator Joni Ernst 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.
This legislation would create an incentive for drug manufacturers abroad to bring their facilities back to the U.S., leading 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. 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.”— Senator Mike Braun
“Giving foreign drug manufacturers in countries like China a ‘heads up’ before facility inspections, while putting our own domestic producers at a disadvantage, makes about as much sense as relying on the CCP to make these critical goods in the first place. This bill will put American producers on a level playing field with foreign competitors, help bring manufacturing back to the U.S., and reduce our reliance on Communist China.”— Senator Joni Ernst
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.
