July 11,2019

Grassley Statement on FDA’s Capability Assessments for European Union Member States

WASHINGTON – Senate Finance Committee Chairman Chuck Grassley (R-Iowa) released the following statement regarding the U.S. Food and Drug Administration’s (FDA) use of the Mutual Recognition Agreement (MRA) with the European Union (EU) to help ensure the safety and quality of prescription drugs in the United States.


“Anytime the federal government can reduce inefficiencies and utilize taxpayer dollars more productively, it should be commended. The U.S. Food and Drug Administration’s efforts to update and implement a cooperative inspection program with our allies in the European Union are aimed at ensuring patient safety, improving the use of resources and reducing wasteful government spending.


“These are good faith efforts. However, the United States must remain vigilant and aggressively oversee the program in order to keep inspection standards high and ensure the safety and quality of our prescription drugs. While we trust our allies to uphold stringent measures, we cannot become complacent or allow bad actors to participate in this newly revived program. There have been too many examples of failed quality controls coming from facilities in countries like China and India to trust inspections without proper verification.”


According to a statement released by FDA, the MRA is designed to ease part of this burden and minimize resource-intensive duplicative inspectional efforts by the U.S. and the EU. The EU conducts similar inspections of establishments that manufacture medicines to be used in the EU, so under the MRA, the FDA may rely on the inspectional findings of EU member states in a European facility that will export to the U.S., and an EU nation may accept the FDA’s inspectional findings at a U.S. facility that exports to a nation in the EU. 


In June, Grassley sent a letter to Department of Health and Human Services (HHS) Secretary Alex Azar and FDA Acting Commissioner Norman Sharpless seeking information on the quality controls for prescription drugs and their components manufactured in foreign countries, specifically China and India. The letter also asks what the FDA is doing to uphold safety standards in the United States, China, and India via inspections of manufacturing facilities. 


Reports have noted that 80 percent of active pharmaceutical ingredients are produced in China and India and that facilities in those countries have not maintained adequate quality control standards.