Grassley Says Unannounced Inspections of Foreign Drug Manufacturers Needed
The Food and Drug Administration should reinstate unannounced inspections of drug manufacturing facilities outside the U.S., Senate Finance Committee Chairman Chuck Grassley, R-Iowa, said in a letter to the agency Aug. 6. Grassley said he brought the issue up since…
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the administration is considering regulations that would allow drug importation from Canada in order to help drive down the prices of prescription drugs (see 1907310018). He noted that the FDA does not keep records of whether inspections were unannounced or planned in advance, and that the agency told him that they generally do not do unannounced visits abroad, though they do domestically. "[I]n 2013 the FDA created a pilot program in India that eliminated advanced notice and instead used short notice or unannounced visits. The pilot program also arranged for FDA inspectors’ travel to be arranged through the U.S. embassies instead of through FDA offices or manufacturer-arranged travel plans to provide more secrecy in the lead-up to inspections," Grassley wrote. "According to reports, the new inspection regime 'exposed widespread malfeasance' that had otherwise been hidden because of the advanced warning system." For instance, inspectors found fake laboratories and missing samples. The pilot program ended in 2015, and Grassley thinks it should not have.