Safer eyedrops will require new FDA powers and resources, experts say
Repeated recalls of eyedrops are drawing new attention to the limited powers U.S. regulators have to oversee medical products made overseas
WASHINGTON (AP) — When you buy eyedrops at a U.S. store, you might assume you're getting a product 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 U.S. 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 U.S. 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.”
