A highly drug-resistant "superbug" bacteria that was linked to eyedrops imported from India and that spread from person to person in a Connecticut long-term care center has prompted concerns that the strain could gain a foothold in the U.S. and highlighted issues around lack of scrutiny of far-flung manufacturers.
The New York Times reports that, in recent months, three deaths, eight cases of blindness and dozens of infections have been traced to EzriCare artificial tears, according to the Centers for Disease Control and Prevention (CDC), leading to a widespread recall this year.
The Food and Drug Administration (FDA), which regulates over-the-counter medicine, has stopped imports of the product. But these outbreaks highlight regulatory gaps in controlling imports of overseas medications.
A myopic approach to supply chain management doesn’t help. Global Pharma did not respond to questions in March. But on February 1, the company said it had “not determined whether our manufacturing facility is the source of the contamination.” EzriCare said on its website that it marketed the drops, but that it had no role in the “actual manufacturing of this product.” Wal-Mart and Amazon, among the larger retailers that sold the drops, did not respond to requests for comment.
The FDA has long been criticized for lapses in inspections of overseas manufacturing in China and India, which are the two major producers of drugs and raw ingredients for medicines. While the F.D.A. requires a pre-approval inspection of plants that manufacture prescription drugs, there is no such mandate for those that make over-the-counter medicines like artificial tears.
Compounding the problem, the number of inspections the agency conducts has plummeted since the pandemic began.
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