How we did it
Making Mermaid Tears™
A funny story which is also true
Cast of Characters:
the fall guy, the chief scientist, the box art wizard
Part 1
An OTC pretender with a mystery ingredient
In early 2022, the fall guy and the chief scientist discovered DailyMed, the National Library of Medicine’s public drug database.
At the time we were primarily working on the patient safety issue of preservative-free eye drops incorrectly packaged in standard eye drop bottles.
On DailyMed we learned that Regenerative Processing Plant LLC, manufacturer of two of these eye drops, had somehow obtained over-the-counter (OTC) drug listings with the FDA.
The Regener-Eyes® eye drops contain a mysterious – and highly marketable – “biologic” ingredient that cannot be found in the FDA's vast ingredient XL spreadsheet. Drugs that contain biologic ingredients require FDA approval as prescription drugs prior to marketing and sale.
Bold as a hunting orca, the mystery ingredient (initially d-MAPPS™, subsequently Tonicity Solution™) appears on both products’ DailyMed labels. And the distributor, Regener-Eyes LLC, was everywhere on the internet describing the all-natural, preservative-free, biologic awesomeness of its eye drops.
How could these OTC listings have come to be?
Didn’t anyone at the FDA wonder what d-MAPPS™ was?
The chief scientist hypothesized that the FDA’s drug listing portal – called CDER Direct – was self-service and fully automated for OTC products.
Using CDER Direct, anyone could make anything, on a very shaky honor system. Specifically, the portal could be used by an unscrupulous manufacturer to create a legal-looking DailyMed OTC drug listing for a not legal – that is, not approved – prescription drug. This has obvious marketing advantages.
We decided to test the hypothesis.
Part 2
Ocean Tears LLC
First, the fall guy formed Ocean Tears LLC and registered it with the FDA.
Next, the fall guy and the chief scientist dreamed up OceanTears™, which contains a mystery biological substance of its very own: AmnioP™. The box art wizard designed an elegantly ocean-themed box.
Next, the chief scientist did battle with CDER Direct.
This involved many hours and much profane commentary about the inscrutable CDER-speak of the error messages. God forbid the user should complete a Warnings & Precautions Section, when the product must have a Warnings Section.
Through repeated experimentation, the chief scientist conquered the error messages. After that, getting AmnioP™ into the drug label and onto the product box was simple. You can enter whatever you want in those free-text data fields. Really, anything.
OceanTears™ went live on DailyMed about three days after the listing was submitted. We celebrated.
Quod erat demonstrandum.
Part 3
Mermaid Tears™
The chief scientist was on a roll. Why waste all that hard-earned knowledge of CDER Direct?
And sure, OceanTears™ was sufficient proof that CDER’s software had blind spots. But the OceanTears™ DailyMed listing seemed both boring and plausible, with standard language and one fine-print mystery ingredient that could be overlooked. Just like the Regener-Eyes® labels, in other words.
The chief scientist decided to create a truly preposterous eye drop listing, complete with inscrutable biologic ingredient acronym and tattoo artist-style box art.
Inside the chief scientist is a mad scientist, evidently.
Precautions During Use:
Objects under water are closer than they appear.
This means sharks.
Want to know what BOPE™ is?
It’s proprietary, we’re not telling.
And we didn’t forget the preservative.
It’s preservative free. It says so on the box.
There’s nothing wrong with the bottle. All the big drug companies have used it for years.
OceanTears™ took two weeks of intermittent but intense effort. The preposterous drop took about 40 minutes, half of it spent on creative writing and half on data entry. Words like aquarium, genome, and spontaneous + carbonation swam freely in the ocean of free-text data fields, unchallenged by any error message.
Secretly, the fall guy expected a call from the FDA asking what the hell we thought we were doing.
Or at least an email with a really nasty error message.