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Pharmaceuticals / Regulatory Affairs

House E&C Committee Calls for FDA Briefing on Sartan Recalls, Foreign Inspections

Feb. 22, 2019

Members of the House Energy and Commerce Committee sent a letter to FDA Commissioner Scott Gottlieb calling for a briefing on the ongoing recalls of sartan blood pressure drugs and on the agency’s foreign inspections.

The lawmakers noted that the FDA’s foreign drug inspections fell to 778 in fiscal 2018, down 10 percent from the previous year, which was in turn down nine percent the year before.

The decline in foreign inspections by the agency coincided with a series of blood pressure medicine recalls — 15 since July 2018 — stemming from APIs from two foreign factories, Zhejiang Huahai Pharmaceutical in China and Hetero Labs in India. FDA inspections in India went up 18 percent in fiscal 2018 but declined by 11 percent in China, they noted.

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