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More Outsourcing Planned for FDA Overseas Factory Inspections

U.S. regulators plan to outsource more inspections of overseas factories within the next decade after criticism from Congress about a lack of oversight for food and drugs made in other countries.

The Food and Drug Administration aims to increase its reliance on third-party inspectors and has started reaching out to industry trade groups about the change, John Taylor, the agency’s acting principal deputy commissioner, said today. The agency will work more closely with other countries and share findings, potentially reducing the number of inspections plants would undergo each year, he said.

The FDA inspects foreign drug facilities once every nine years on average, compared with once every 30 months for U.S. plants, the Government Accountability Office reported in September. While the agency has had federal employees in countries such as China since 2008, Taylor said this model for increasing oversight won’t be sustainable as demand for lower-cost resources leads to more non-U.S. manufacturing.

“We recognize that third-party inspection programs need to be a bigger part of the discussion because we can’t do all the work ourselves,” Taylor said at a conference in Washington sponsored by consulting firms Venn Strategies LLC and Greenleaf Health LLC. “We’re looking at anything, anything and everything that will allow us to leverage our resources better.”

FDA Commissioner Margaret Hamburg’s two top priorities are globalization and innovation, Taylor said. A former executive at Abbott Laboratories in Abbott Park, Illinois, and the Biotechnology Industry Organization trade association in Washington, Taylor became the agency’s No. 2 official after Joshua Sharfstein resigned last month to become Maryland’s top health official.

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