Foreign Drug Inspections the Focus of House E&C Committee Letter to Califf

Republican members of the House Energy and Commerce (E&C) Committee are pressing FDA Commissioner Robert Califf on the effectiveness of the agency’s foreign drug inspection program given that numerous Indian and Chinese firms have repeatedly flouted FDA regulations.

In a letter dated July 18, Chair Cathy McMorris Rodgers (R-Wash.), Subcommittee on Health Chair Brett Guthrie (R-Ky.) and Subcommittee on Oversight and Investigations Chair Morgan Griffith (R-Va.) outlined a series of ongoing concerns regarding the FDA’s foreign inspections, the latest in a back-and-forth between the committee and the agency.

Chief among the committee’s concerns is that Chinese and Indian manufacturers have received several agency warning letters for major violations, such as the presence of carcinogens in medications, destroying or falsifying data and having non-sterile manufacturing processes.

“Given that approximately 32 percent of generic drugs and 45 percent of active pharmaceutical ingredients are from these two countries,” they continued, “we are worried that the United States is overly reliant on sourcing from foreign manufacturers with a demonstrated pattern of repeatedly violating FDA safety regulations.”

Read the latest letter from the House E&C Committee here.

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