EGG-NEWS has previously commented on numerous cases of keratitis and panophthalmitis associated with the use of contaminated eye drops manufactured in India and distributed extensively in the U. S. by chain pharmacies.
Seventy infections with multidrug resistant Pseudomonas aeruginosa have been diagnosed with three fatalities in April and May. Contaminated lubricating eyedrops to treat xerophthalmia (“dry eye”) is especially a problem in the elderly.
More recently, Kilitch Healthcare is recalling contaminated lubricating eyedrops sold under 27 brands following an FDA recommendation on October 25th.
At issue is the failure of FDA to inspect pharmaceutical plants exporting to the U.S. exposing consumers to substandard and potentially harmful medications. The FDA did not conduct any inspections in India during Fiscal 2021, apparently as a result of the COVID pandemic. In 2023, inspections rose to 177 but this was less than half the number conducted prior to the onset of COVID. According to records, the implicated plant falsified quality control records, operated at a substandard level of hygiene and failed to achieve or verify sterility of products.
If the FDA cannot effectively inspect and verify the quality and safety of imported pharmaceuticals, it should relinquish the food-related responsibilities that are also deficient notwithstanding recent reorganization and appointments.
As a short-term approach to improving safety, FDA should place greater responsibility on importers to ensure that products sourced from foreign plants are produced in facilities conforming to FDA standards and are both safe and effective before allowing distribution. Importers and distributors are relying on the acknowledged inefficiency and inadequacy of FDA oversight to the detriment of consumers.