Comment by loeg
16 days ago
> because the FDA makes it that way with their paranoid risk averse regulatory process
FDA is constrained by Congress here. Its function (safety and efficacy in advance of marketing) is required by legislation dating to the 60s. Feel free to advocate for Congress to change the law, but it isn't obvious it would be popular with Americans.
> insanely restrictive requirements on what requires a doctor prescription.
I don't think OTC vs Rx rules have much if any impact on drug development expenses.
OTC vs Rx has massive impact on sales volume which has a massive effect on pricing.
That has nothing to do with drug development expense, which is what you claimed originally.
On a unit cost basis, which is the only thing a customer cares about, it absolutely does. You can cover the development costs at a much lower price point if you can sell more units.
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