Background

Senate Finance Committee Chairman Charles Grassley, R-Iowa, is urging the Food and Drug Administration to reinstate unannounced inspections of prescription drug manufacturing facilities in foreign countries.

In a recent letter, Grassley said that in light of a new Trump administration plan on drug importation and the fact that foreign facilities provide 80 percent of active pharmaceutical ingredients for drug production inside the U.S., it is important to determine more accurately if these facilities meet set standards of quality and safety for both domestic and importation purposes. However, he pointed out that the FDA only inspected one in five registered human drug manufacturing facilities abroad in 2018, does not track whether a foreign inspection was announced or unannounced, and in fact generally does not perform unannounced visits of drug manufacturing facilities in foreign countries.

Grassley called for unannounced inspections in light of the apparent successes of a pilot program the FDA conducted in India from 2013 to 2015 that eliminated advance notice and employed other measures to increase the secrecy concerning facility inspections. According to reports, Grassley said, this approach “exposed widespread malfeasance” and yielded a 60 percent increase in FDA “official action indicated” findings.

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