Eight companies are finding themselves in hot water for allegedly churning out illicit eye drugs, the FDA said Tuesday.
The drugs are unapproved and illegally marketed, the FDA said, which is especially risky considering that medications administered through the eye bypass some of the body’s natural defenses. The illegal therapies are purportedly used to treat diseases such as pink eye, cataracts, glaucoma and more, according to the agency's release.
The companies in the warning letter sweep are: Boiron, CVS Health, DR Vitamin Solutions, Natural Ophthalmics, OcluMed, Similasan, TRP Company and Walgreens Boots Alliance.
Consumers using the illicit products should talk to a doctor, according to the FDA. The companies, for their part, must respond within 15 days of receiving the FDA’s warning letters.
CVS appears to be responding quickly. Reuters reports the company said it has stopped the sale of its Pink Eye Relief Eye Drops and that customers who purchased the product could return it to the company's pharmacy for a full refund.
If companies fail to respond, the FDA said it could pursue legal action, including product seizure and/or a court order requiring the company to stop manufacturing and distributing the unapproved drug.
The agency says its review of eye products is ongoing. It may take additional regulatory or enforcement actions as warranted.
While much of the FDA's efforts center around reviewing data on new treatments, the agency routinely scans the marketplace for illicit drugs. In one recent instance, the FDA warned against unauthorized incarnations of Novo Nordisk’s obesity blockbuster Wegovy coming out of compounding pharmacies.
And way back in 2011, the FDA took similar action against companies selling unapproved prescriptive oral cough, cold and allergy meds. The FDA demanded that companies selling the illicit drugs stop manufacturing the products within 90 days and stop shipping them within 180 days.