It's gatekeeping regulation under the guise of "quality control". Drug companies don't want competition from the bottom, they're happy with a regulatory framewo

It's gatekeeping regulation under the guise of "quality control". Drug companies don't want competition from the bottom, they're happy with a regulatory framework that keeps small companies from entering the market. Insulin itself would be simple and cheap to produce, but getting through the approval process is so expensive, it wouldn't make economical sense to then sell the product near cost. Insulin isn't the mass-market product it once was, because it has fallen out of favor for Type II diabetes and Type I diabetes is relatively rare. The way other countries get around this is price controls. They just tell the companies what drugs are allowed to cost, so profits are limited not by competition, but by fiat.