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November 30, 2023
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BLOG: Sometimes brand matters: FDA forces recall of 27 generic artificial tears

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Key takeaways:

  • Seven companies failed sanitary inspections of their manufacturing facilities.
  • Eye care professionals should insist that patients use brand-name artificial tears.

Oh my. Another FDA recall of generic artificial tears hit the news during eyeball month.

Both the American Academy of Ophthalmology and American Academy of Optometry recently held their big annual conferences. To mark this auspicious calendar event (hey Monie Hussain, how come October or November isn’t officially Eyeball Month?), the FDA announced that 27 generic artificial tear lubricants made by or for seven companies had failed sanitary inspections of their manufacturing facilities. Coming on the heels of news earlier this year about non-brand artificial tears made by EzriCare and Delsam that resulted in some 18 cases of blindness and several deaths, brand-name lubricating drops never looked better.

Darrell White, MD

The companies involved are CVS, Rugby (Cardinal Health), Leader (Cardinal Health), up & up from Target, Rite Aid, Velocity and Equate from Walmart. I should be clear that there have been no reported infections, blindness or death from this latest concern, only notification that factories failed to maintain basic minimal levels of sanitation and sterility. Not that this is a trivial issue, of course. These are very big companies, a few of them with very prominent brands. Imagine if a major restaurant chain had its suppliers investigated and found to be lacking when it came to sanitary conditions.

You’d cross that chain off your list of options forever.

We live in an era of irrational financial decision-making, especially when it comes to health care. I mean, folks line up at their local Starbucks and spend $8 once or twice every day, yet they will drive 45 minutes to Walmart or Costco in order to buy generic Zyrtec and save a buck 50. The difference between some lousy OTC artificial tear and some rock-solid brand like Refresh (Allergan) or Systane (Alcon) is one bloody double-shot flat white sugar-free oat milk capalatte. And the bottle lasts a month!

Listen, I’ve made some artificial tear companies very sad by repeatedly saying that artificial tears don’t really work. My badmouthing notwithstanding, the topical eyeball lubrication market is almost a billion dollar a year business in the U.S. Might be more. Sanitary manufacturing processes that result in a sterile product is the table stake. There’s no need for grandstanding and chest thumping if you are a brand, big or little. You’re supposed to make, package, deliver and sell a product that doesn’t maim or kill folks.

Count me in as a member of team Dr. Glaucomflecken. Generics for stuff like acetaminophen are fine, but if it’s going in someone’s eye, insist on established brands. Big (Alcon, Allergan, Bausch + Lomb, etc) or small (Thea and iVIZIA, Scope and Optase, etc). Peace of mind for the cost of one cup of fancy coffee.

Sources/Disclosures

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Disclosures: White reports consulting for Aldeyra, Avellino, Bausch + Lomb, Johnson & Johnson, Novartis, Orasis, Rendia, Santen, Sight Sciences, Sun, Tarsus and Trukera Medical; speaking for Novartis, Santen and Sun; and having ownership interest in Orasis.