Are we really complaining about an "onerous regulatory process" for a device which untrained laymen need to be able to use in a high stress emergency situation?
I'd like to see Four Thieves Vinegar fund the necessary trials to prove their device is safe, gain FDA approval, bring the device to market, and defend themselves against the inevitable lawsuits, and then tell us how they can sell the device with less than 80% gross margins. The marginal cost of making one more pill or one more device is almost entirely irrelevant, and any article that tries to make a case for a medical product being overpriced based on COGS isn't worth reading IMO.
The price for EpiPens went up because no one else was able to make a competing product that didn't malfunction or deliver the wrong dose of epinephrine.