very stupid question, why dont we have a startup say from india that ships container full of diabetes meds directly to people that need them and a person in the USA who handles the distribution. Even with shipping cost included, I dont think it ll be more expensive
Regulations make this very difficult. Take a look at FDA Section 804. Startup cost is in the low tens or hundreds of thousands just to get the application accepted and then the ongoing yearly cost is in the millions. Currently, the FDA makes it very difficult for new competitors to enter the market because of these really high fees. This is part of, but not the whole, reason why drugs cost so much in the US.
That’s not because of the FDA, that’s because of CEPS. If the USG negotiated drug prices the way France does, there’d be far less disparity in average pricing. (Given the continual litany of safety, efficacy, and dosage control issues with imported drugs, FDA isn’t regulating them enough, largely because the inspection budget just isn’t there.)
