Senators Propose Bill to Balance FDA’s Domestic, Foreign Inspections Requirements

Sens. Joni Ernst (R-Iowa) and Mike Braun (R-Ind.) have introduced a bill to eliminate the advance notice foreign drugmakers receive before an FDA inspection to level the playing field for domestic companies that don’t typically receive any such prenotification.

The Creating Efficiency in Foreign Inspections Act is meant to do away with the incentive drug manufacturers have to keep their facilities abroad and urge pharma companies to ship their plants back to the U.S. to strengthen the supply chain.

“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 [Chinese Communist Party] to make these critical goods in the first place,” said Ernst.