When you buy eyedrops at a US store, you might assume the product was made in a clean, well-maintained factory that's passed muster with health regulators. But repeated recalls involving over-the-counter drops are drawing new attention to just how little US officials know about the conditions at some manufacturing plants on the other side of the world—and the limited tools they have to intervene when there's a problem. The Food and Drug Administration is asking Congress for new powers, including the ability to mandate drug recalls and require eyedrop makers to undergo inspections before shipping products to the US, the AP reports. But experts say those capabilities will do little without more staff and resources for foreign inspections, which were a challenge even before the COVID-19 pandemic forced regulators to skip thousands of visits.
"The FDA is not getting its job done in terms of drug quality assurance inspections abroad," said David Ridley of Duke University and co-author of a recent paper tracking the downturn in inspections. "Very few foreign drugmakers have been inspected in the past four years." In 2022, FDA foreign inspections were down 79% from 2019, according to agency records collected by Ridley's group. Inspections increased this year but are still far below pre-pandemic levels. FDA spokesman Jeremy Kahn said, "The FDA works to inspect as many facilities possible, but ultimately industry is responsible for the quality of their products."
An October recall of two dozen eyedrop brands came after FDA staff found cracked floors, barefoot workers, and other unsanitary conditions at a Mumbai plant that supplied products to CVS, Walmart, and other major retailers. It was the first time FDA staff had visited the site, per the AP. That inspection was prompted by an earlier recall of tainted eyedrops from a different Indian plant that's been linked to four deaths and more than a dozen cases of vision loss. That plant had also never been previously inspected. "These are very rare instances, but what we've seen is that these products can cause real harm," said Dr. Timothy Janetos, an ophthalmologist at Northwestern University. "Something needs to change." Experts suggest possible remedies:
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- Earlier inspections: The FDA asked Congress for the power to require manufacturers of eyedrops and other sterile products to give at least six months' notice before shipping products from a new factory. That would give inspectors time to visit facilities that aren't on their radar.
- Requiring recalls: The FDA warned consumers in late October not to use eyedrops sold at CVS, Rite-Aid, and other stores. But the products weren't officially recalled until almost three weeks later because an Indian manufacturer, Kilitch Healthcare, initially declined to cooperate. The FDA can force recalls of food, medical devices, and other products, but not drugs. The agency has asked Congress for that authority.
- Funding foreign inspectors: Drug manufacturing has increasingly moved to India, China, and other lower-cost countries. The Government Accountability Office has raised concerns for years about FDA oversight of the global supply chain. FDA leaders say it's challenging to recruit and keep overseas inspectors. Experts say Congress should address that.
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