Repeated recalls of eyedrops are drawing new attention to the limited powers U.S. regulators have to oversee medical products made overseas. Unlike prescription drugs, eyedrops and other over-the-counter products don t get preliminary review by the Food and Drug Administration. In the case of two eyedrop recalls earlier this year, FDA inspectors had never previously visited the plants in India. In both cases, when FDA inspectors arrived on site they found dangerous conditions. The FDA is asking Congress for new powers, including the ability to require drugmakers to immediately recall products. But experts say those authorities will do little without more resources for foreign inspections.
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.
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.
Repeated recalls of eyedrops are drawing new attention to the limited powers U.S. regulators have to oversee medical products made overseas. Unlike prescription drugs, eyedrops and other over-the-counter products don t get preliminary review by the Food and Drug Administration. In the case of two eyedrop recalls earlier this year, FDA inspectors had never previously visited the plants in India. In both cases, when FDA inspectors arrived on site they found dangerous conditions. The FDA is asking Congress for new powers, including the ability to require drugmakers to immediately recall products. But experts say those authorities will do little without more resources for foreign inspections.
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.