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Regulatory Focus™ > News Articles > 2019 > 8 > Grassley Calls for More Unannounced Foreign Drug Inspections From FDA

Grassley Calls for More Unannounced Foreign Drug Inspections From FDA

Posted 12 August 2019 | By Zachary Brennan 

Grassley Calls for More Unannounced Foreign Drug Inspections From FDA

As the US Food and Drug Administration (FDA) explores plans to lower the cost of pharmaceuticals with imports from Canada and elsewhere, Sen. Chuck Grassley (R-IA) is calling on the agency to perform more unannounced inspections of foreign facilities.

Thanks to recent media coverage (on China and tainted blood pressure medicines and another article on generic drug manufacturing) as well as a controversial new book on the US reliance on foreign-made generic medicines, Finance Committee Chairman Grassley said he has learned that FDA does not track whether a foreign inspection was subject to an announced or unannounced visit and that FDA generally does not perform unannounced visits of manufacturing facilities overseas.

Moving forward, should the administration’s plans to allow certain imports be put into effect, the administration “must require more foreign inspections generally and unannounced inspections specifically, particularly compared to previous administrations,” Grassley writes.

He also questions why a 2013 FDA pilot program in India “that eliminated advanced notice and instead used short notice or unannounced visits” was “shut down without explanation” in 2015. He says the pilot “exposed widespread malfeasance” that had otherwise been hidden because of a previous system that allowed advanced warnings for manufacturing sites.

“I strongly encourage the administration’s demonstration projects to include unannounced inspections in foreign manufacturing facilities to determine whether they meet the required API [active pharmaceutical ingredient] and drug quality and safety standards to include sufficient record-keeping, testing, and protections against counterfeiting,” he adds.

Grassley’s letter follows a June letter from the House Energy & Commerce (E&C) Committee also questioning the agency’s work overseas, and another letter to the US Government Accountability Office (GAO) seeking a review of FDA’s drug inspection program.

GAO in 2017 questioned parts of FDA’s drug inspection program and noted that FDA has struggled to fill its China and India-based offices.


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