Bloomberg Businessweek's "No Testing, No Inspections: Contaminated Eyedrops Blinded and Killed Americans" story exposes "gaping hole" in regulatory system
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POULSBO, Wash., July 25, 2023 /PRNewswire/ -- Bloomberg Businessweek magazine has reported the results of a months-long investigation into how generic over-the-counter eye drops contaminated with an "antibiotic-resistant superbug" made it into the US market. The eye drop story appeared in Bloomberg Businessweek's July 23 issue and was subtitled "How a drugstore staple, made in an Indian factory and tainted with an antibiotic-resistant superbug, slipped past the FDA." Bloomberg identifies serious shortcomings in FDA regulation of over-the-counter drugs, which it describes as the agency's "lowest priorities."
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"These drugs are essentially produced and sold on the honor system," states the Bloomberg article. "A company doesn't have to prove to the agency that its medicine is safe or effective or that it's being made in proper conditions. There's no testing involved; no inspection required…. Basically, paperwork." Experts in public health and infectious disease epidemiology as well as a former FDA official contributed to the article, citing concerns about lack of oversight, facility inspection protocols, testing, and the difficulty of tracing a superbug to an OTC drug. "The American public should know that nobody's looking. It's not the FDA's fault that they don't have the resources to do this. But they shouldn't pretend that they can," says Stanford professor Kevin Schulman.
"The Dry Eye Foundation has been sounding the alarm about potentially unsafe OTC eye drops for some time," says Sandra Brown MD, Dry Eye Foundation's medical advisor. As discussed in the Bloomberg story, the Foundation recently took an unusual step: testing the FDA's OTC drug listing system by creating and submitting satirical products, each with an unidentifiable ingredient. The second product includes many completely absurd warnings and instructions. Yet it passed through the FDA's system without comment. "We know anyone can sell "black market" eye drops on Amazon, Walmart.com or Ebay," says Dry Eye Foundation president Rebecca Petris. "Unfortunately, now we also know that anyone who's motivated can get their eye drop listed with the FDA to make it look more official. We know one company that has been doing that for almost two years."
Dry Eye Foundation has shared its concerns about the proliferation of unsafe OTC eye drops with the FDA, and is meeting with agency representatives in September.
Dry Eye Foundation operates two websites about eye drop safety: eyedropsafety.org and mermaidtearsusa.com.
The Dry Eye FoundationThe Dry Eye Foundation is a 501(c)(3) nonprofit organization based in Poulsbo, Washington.
Its mission is to improve patients' quality of life. The ocular surface diseases and ocular surface pain disorders that many patients face have profound functional, financial and emotional impact. Dry Eye Foundation is working to restore hope, redefine disease and reshape the future for people with these conditions, through its community service, education, research and advocacy programs.
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Aidan MooreRebecca Petris[email protected]
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SOURCE The Dry Eye Foundation
