FDA only inspected 6% of foreign drug manufacturers in 2022: Report

With the exception of critical cases, during the coronavirus pandemic the FDA mostly halted the inspections of overseas drug manufacturing sites. Now, long after they have resumed, the FDA is still very much behind schedule. In 2022, the agency only inspected 6 percent of overseas facilities, according to an investigation from ProPublica.

The U.S. gets 80 percent of its drugs from manufacturers overseas. One of the major consequences of the agency falling behind on these critical inspections was on display just a few months back when it recalled eye drops due to bacterial contamination at a plant in India that led to several instances of individuals going blind and even led to death in a few cases. According to the report, the manufacturing facility where the eye drops were made, was one that "the agency had never inspected prior to the outbreak."

Inspections of these overseas facilities have historically been low, and per the report, data shows the FDA's backlog of foreign inspections is worsening.

"The percentage of overseas manufacturers that hadn’t been inspected within five years, or which have never once been inspected, has grown from 30 percent in 2020 to more than 80 percent in 2022," according to the ProPublica report. 

Just like in 2022, the FDA's foreign inspection numbers were also low in 2021 at just 4 percent of eligible foreign manufacturers. Four percent in 2021 and 6 percent in 2022 are concerningly low to experts, particularly since such a large number of the U.S. drug supply comes from overseas, according to ProPublica

The FDA did not respond to ProPublica with comment and has not yet shared any response via a press release on its website. Becker's is tracking this story and will publish updates if new information becomes available.

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