After Recalls and Infections, Experts Say Safer Eyedrops Will Require New FDA Powers

WASHINGTON — 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. [time-brightcove not-tgx=”true”] 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.” 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: “Th...
Source: TIME: Health - Category: Consumer Health News Authors: Tags: Uncategorized healthscienceclimate wire Source Type: news