This week, FDA Commissioner Scott Gottlieb announced that inspections by drug regulatory authorities of foreign manufacturing plants that export pharmaceuticals to the U.S. are sufficient to ensure the integrity of those products: meaning the FDA doesn’t also need to inspect them. The countries identified are Austria, Croatia, France, Italy, Malta, Spain, Sweden, and the United Kingdom. All are currently members of the European Union (the UK is soon Brexiting).
Although this has made headlines as an unprecedented practice, the FDA relying on inspections from foreign regulators is not an entirely new development. The FDA does not inspect all foreign plants that export medicine to the U.S. even though most pharmaceuticals sold in the U.S. are foreign-made.
So what’s with the big announcement then?FDA Commissioner, foreign made, Scott Gottlieb