Health officials are looking to ensure the safety of eye drops after months of numerous recalls, but this will require new FDA powers.
The FDA is asking Congress for new oversight abilities such as requiring overseas manufacturers to undergo inspections prior to shipping their products and for mandatory recall authority over medications, reported AP.
“The FDA is not getting its job done in terms of drug quality assurance inspections abroad,” said David Ridley of Duke University, per AP. “Very few foreign drugmakers have been inspected in the past four years.”
Ridley is the co-author of a new study published this month which found that global drug inspections on the part of the FDA have been decreasing since the COVID-19 pandemic, noting that foreign inspections had been rising before its onset.
“After the onset of the COVID-19 pandemic and the release of the FDA’s revised industry guidance, the number of inspections declined significantly and had not recovered as of 2022, especially for foreign establishments,” says the study. “In 2022, total annual foreign inspections were down approximately 79 percent compared with 2019, whereas total annual domestic inspections had decreased by around 35 percent.”
Part of the problem is that over-the-counter products, which include eyedrops, do not require any sort of review or inspection prior to manufacture. As long as manufacturers of over-the-counter products use a “monograph” — regulatory standards that specify the active ingredients, labeling, and other general requirements — they can begin producing medicine within days of filing with the FDA.
“These are very rare instances, but what we’ve seen is that these products can cause real harm,” said Dr. Timothy Janetos, an ophthalmologist at Northwestern University, per AP News. “Something needs to change.”
When a new factory is involved in the production of sterile products, the FDA wants to require manufacturers to provide at least six months’ notice prior to shipping any products, thereby giving FDA inspectors sufficient time to inspect, reported AP.
Not every over-the-counter product can cause the harm that eyedrops can.
“Anything you swallow is going to meet up with your stomach acid, which is going to kill most bacteria,” said Dr. Sandra Brown of the Dry Eye Foundation, per AP. “It’s much more dangerous to put a product in your eye.”
Part of the challenge for the FDA is recruiting and maintaining a staff of overseas inspectors.
“Federal hiring is inherently slow and pay is often not competitive,” said Ridley, per AP. ”Congress needs to try and help FDA solve that problem and then hold them responsible for staffing inspections.”
In the last few months, the FDA has issued recalls for numerous brands of over-the-counter eye drops, warning consumers not to use them due to fear of unsterilized drops resulting in infections leading to loss of vision or even blindness. The latest update from the agency revealed that the list of impacted products from various entities had risen to 27, as previously reported by The Dallas Express.
