The FDA’s weak drug manufacturing oversight is a potentially deadly problem
The ConversationJun 30, 2023
According to the US Food and Drug Administration (FDA), at least 26 over-the-counter eye drop brands, including those sold under store brands could lead to serious eye infections resulting in vision loss or blindness. The agency is calling for the recall of store brands from CVS Health, Rite Aid, Target Up&Up, Leader (Cardinal Health), Rugby (Cardinal Health), and Velocity Pharma.
This follows an FDA inspection of the manufacturers' facilities, during which it found unsanitary conditions and positive bacterial test results in "critical drug production areas."
US pharmaceutical companies have for decades outsourced drug manufacturing overseas, leading to challenges in FDA oversight. While foreign inspections have intensified, domestic oversight has waned. This shift, combined with reduced inspections, raises concerns about the quality and safety of common-use drugs available to Americans. The government should have changed course after it recalled 60M Johnson and Johnson vaccines, but since it didn't, hopefully, these latest headlines will bring institutional change.
The FDA's job is to do exactly what it did regarding these dangerous eye drops. The agency conducts inspections of medical facilities ranging from drug manufacturers and blood banks to food processing plants and tobacco manufacturers. When companies disregard federal law and put Americans at risk, the agency will be there to uncover such violations, warn the public about them, and hold those responsible to account.