Ever found yourself at the store, reaching for the most convenient bottle of over-the-counter eyedrops, assuming whip-smart regulators have given it a clean, green tick? Well, a rising tide of recalls has thrown a damp cloth on this assumption. It seems our officials are under-armed, facing a game of hide-and-seek with global manufacturing plants playing on the home field advantage.
The knight in shining armour — The Food and Drug Administration (FDA) — is ringing the alarm and calling on Congress to reinforce their arsenal. Mandatory drug recalls and conditional shipments subject to prior inspection from eyedrop manufacturers are just a couple of the notches they aim to add onto their belt of power.
But, even the mightiest knight needs his round table. Without increasing staff and pouring resources into foreign inspections, these proposed powers might merely act as ceremonial armours against the dragon of poor quality controls. David Ridley of Duke University warns, “The FDA is not getting its job done in terms of drug quality assurance inspections abroad.” The pandemic has further lowered the drawbridges, and foreign inspections have plummeted by 79%.
Our tale took an eerie turn last October when an inspection resulted in recalls of two dozen eyedrop brands. Shadows were cast on a Mumbai plant — guilty of cracked floors, workers sans shoes and unsanitary conditions — which supplied products to the pillars of retail: CVS, Walmart and other major players.
Earlier, an unvisited Indian plant had brewed a batch of tainted eyedrops fatal enough to claim four lives and leaving more than a dozen people blinded. Northwestern University’s ophthalmologist Dr. Timothy Janetos urges, “Something needs to change.”
So where do we go from here? The crux of the story lies in blueprinting an efficient system for regulatory assurances. A few suggested ways include systematic earlier inspections and incorporation of mandatory recalls. But, the whole paradigm of over-the-counter products must be broken down in a world where tainted eyedrops pose lethal risks.
Moreover, the FDA is saddling up to push for a provision to allow manufacturers a six months heads-up before shipping products from a new factory. But, facing the gorgon's gaze are over-the-counter drug makers, who may not cozy up to the regulations.
But at the end of this winding road, the stakes are high and the chance is nigh. As Dr. Sandra Brown of the Dry Eye Foundation says, “It’s much more dangerous to put a product in your eye.”
We wait with bated breath as a possibility of Congress introducing mandatory recall courts the horizon. And, if there's one thing clear from this signpost, it's that the FDA needs an army of foreign inspectors to keep up the good fight.
As we write this metaphorical tale rooted in reality, we must remember that the dragon of harmful products may be held at bay. But it requires our collective effort, will, and the needful intervention of our elected lawmakers. It’s a story that impacts us all, as our vision of a safer world is far from just a fairy tale. It is a necessity. Let's hope our tale ends with: 'and they all lived safely ever after.'
