Making Mermaid Tears™
Mermaid Tears™ is a fictitious product that will never be manufactured, marketed or sold.
We invented it to make a point about over-the-counter (OTC) eye drops.
Is anyone in charge?
We know that the FDA approves prescription eye drops. This is a process that takes many years and millions of dollars, because they have to prove that the eye drops are safe, and that they work, at least for some of us.
But what about over-the-counter eye drops?
It turns out that the FDA sets the rules and walks away.
It’s a little more complicated than that, but not much. Companies upload their product information to the FDA, which publishes it on DailyMed, a publicly searchable drug database.
What happens when a rogue manufacturer decides to beat the system - by listing an eye drop that was supposed to get prescription drug approval, but didn’t?
An OTC pretender with a mystery ingredient
We discovered that Regener-Eyes, an unapproved prescription-only biologic eye drop brand, had snuck its products into the FDA’s OTC product database.
These eye drops contained a mystery ingredient (i.e. an ingredient that didn’t match up to anything in the FDA’s vast ingredient database) and lacked a preservative, which was required for the type of bottle that was used.
[I don’t remember what was here before I added things that you didn’t like]
Part 1: OceanTears™
Cast of characters: chief scientist, fall guyWe suspected that the OTC drug listing process must utilize self-service software that is fully automated, and we decided to prove it if we could.
One of us (the fall guy) formed Ocean Tears LLC and registered it with the FDA.
The chief scientist and the fall guy invented OceanTears™, which contained its own mystery substance - AmnioP™.
Despite a large number of failsafes built into the FDA’s software, getting a fictitious biologic ingredient into the drug listing and onto the box was simple, once the chief scientist figured out how to interpret all the error codes.
OceanTears™ went live on DailyMed about three days after the listing was submitted.
Mission accomplished.
Part 2: Mermaid Tears™
Having put in many frustrating hours mastering the software, the chief scientist decided - purely as a joke - to make a completely preposterous eye drop.
This became Mermaid Tears™, which was so outrageous that we expected a phone call from the FDA asking us what the hell we were doing.
Mermaid Tears™ went live on DailyMed about three days after the listing was submitted.
This proved to us (and the world) that there is no human oversight of the OTC drug listing process whatsoever.
There aren’t even trigger words, like genome or sharks.
A sea of sharks
-Look at what RE has done with dailymed listing (give numbers that will attract journalists e.g. 40 full page ads, buying out KOLs)
-Look at what Ezricare did
-Not all sharks will use DailyMed
-We have a safety problem, and no one knows how large it is (we’re trying, but we’re only three people)
-How will we know when the next problem comes up?