A series of deaths linked to bacteria-tainted eyedrops produced overseas has raised alarm over a lag in FDA inspections.
The Government Accountability Office, a federal watchdog agency, has warned for decades that the number of overseas inspections was worryingly low. Just weeks before the first cluster of COVID-19 patients was reported in China at the end of 2019, the GAO reported that despite some improvements in how the FDA tracked and prioritized its efforts,, due in large part to challenges retaining staff and filling vacancies.
Both the GAO and Rep. Sanford J. Bishop, a Georgia Democrat, say these remote interactions do not offer the same insight that in-person, unannounced inspections do. The FDA itself affirmed the utility of inspections in its: “In the absence of inspections, many of these situations” that could result in defective products, “and possible public harm, could have gone undetected.”
“We have got to be protective of the health, safety and welfare of the American people,” said Bishop, who pushed for funding for overseas inspections in the House. “That is the job of the FDA.”
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