FDA zigs to inspect, zags to funds threat
The FDA says it will turn to contractors in an effort to beef up inspections of overseas drug-making plants. It's an attempt to leverage limited resources, the need for which is heightened by vows of funding scrutiny by members of Congress.
It's simultaneously an attempt to answer Government Accountability Office criticism from last fall that the agency's inspection strategy is misdirected. GAO stats find foreign plant inspections under-represented and an emphasis on plants readying to make newly approved drug. Plants already churning out drugs, inside and outside the U.S., are being checked too infrequently.
"Third-party inspection programs need to be a bigger part of the discussion," says John Taylor, FDA's acting principal deputy commissioner, as reported by Bloomberg. Taylor took over the number two spot following the departure Joshua Sharfstein to head Maryland's health department.
One source the FDA might consider for foreign inspectors is India, which recently has shown interest in enhancing its pharma reputation. Officials announced in August plans to hire drug inspectors to visit the plants of raw material suppliers, notably in China. It boasted nearly 900 inspectors by December, on its way to a short-term goal of 1,400; long term, 3,100. And India has tapped the FDA for training of clinical trial inspectors.
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