Study: Improving eyedrop safety will require additional FDA resources, powers

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Over-the-counter eye drops have been the subject of repeated recalls in 2023, and are focusing increasing attention on how little US officials know about the manufacturing plants or conditions around the world, and the few options they have to jump in when there is a problem.

The FDA is urging Congress to approve new powers for it to be able to mandate recalls and compel eyedrop producers to be subjected to inspections before shipping products to the US. However, industry leaders say this will come up short without additional resources and staff for foreign inspections, a challenge before the pandemic resulted in missed inspections.

In a study, published online in December in Pharmaceuticals & Medical Technology,¹ researchers led by David B. Ridley, PhD, of Duke University, found that during the onset of the COVID-19 pandemic, the FDA stopped inspections of most overseas drug manufacturing establishments.

“Looking at data from the period 2012–22, we observed steep declines in both foreign and domestic inspections in 2020,” the researchers wrote. “By 2022, numbers of inspections remained well below pre-pandemic levels, with a 79 percent decrease in foreign inspections and a 35 percent decline in domestic inspections compared with 2019.”

Moreover, the researchers noted there was no corresponding reduction in drug manufacturing or imports.

“Also, the resources allocated per inspection surged, although the FDA’s overall budget and staffing remained steady,” the researchers wrote. “Finally, citations rose dramatically, despite all establishments being given advance notice of inspections. The findings of our study underscore the pressing need to explore alternative methods for ensuring drug safety.”

In a Wisconsin State Journal report,2FDA spokesman Jeremy Kahn noted that the FDA inspects as many facilities possible, “but ultimately industry is responsible for the quality of their products.”

In October, the FDA recalled two dozen eyedrop brands after inspections uncovered unsanitary conditions at a facility in Mumbai that supplied eyedrops to a number of retailers, including CVS and WalMart.

According to the State Journal report, the inspection was sparked by earlier recalls of tainted eyedrops from another facility in India connected to 4 deaths and even more instances of vision loss. That plant had never undergone an inspection before that time.²

“These are very rare instances, but what we’ve seen is that these products can cause real harm,” said Timothy Janetos, MD, an ophthalmologist at Northwestern University, told the news outlet. “Something needs to change.”

The researchers noted in the face of an unprecedented situation, the FDA prioritized the most pressing inspections in its portfolio during the COVID-19 pandemic.

“To the extent that travel restrictions and safety concerns limited the FDA’s ability to conduct investigations abroad, redirecting those resources to prioritized domestic inspections was wise,” the researchers wrote. “Our analysis, however, suggested that travel restrictions are no longer a first-order concern, and yet most foreign inspections remain on hold.”

The researchers also write it can be difficult to rationalize continuing to postpone foreign inspections, given the data available to authorities.

“As the world moves beyond the pandemic, it is crucial for the FDA to address the backlog of inspections and to consider new approaches for the future,’ the wrote in the study. “We make 5 recommendations.”

Those recommendations include prioritizing foreign inspections, increasing the investigator workforce, increasing international cooperation, spreading the drug quality assurance burden, increasing patients’ awareness of drug quality.¹

According to the researchers, addressing the challenges imposed by the COVID-19 pandemic and the FDA’s response will require combined action by the FDA, Congress, manufacturers, and buyers.

“Past collaborations in other areas of FDA responsibility have been successful, including speeding important drugs to market,^3,4 encouraging development of drugs and vaccines for rare and neglected diseases,^5,6 and reducing drug shortages,⁷” researchers concluded in the study. “We hope that implementing the recommendations outlined above will promote the use of safe and effective medicines beyond the COVID-19 era.”

References:

1. Emily Cuddy, Yun Peng Lu, David B. Ridley.FDA Global Drug Inspections: Surveillance Of Manufacturing Establishments Remains Well Below Pre-COVID-19 Levels. Pharmaceuticals and Medical Technology. Vol 42. No. 12. Published December 4, 2023. Accessed December 20, 2023.

2. Press MPA. After recalls and infections, experts say safer eyedrops will require new FDA powers. Wisconsin State Journal. Published December 15, 2023. Accessed December 20, 2023. https://madison.com/news/nation-world/business/health-care/eyedrops-recall-fda-inspection-safety-factory/article_98558d88-69d9-5ca1-be00-075dcdb7ac9f.html#:~:text=The%20FDA%20says%20it%20has

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