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terminalshorttoday at 2:27 AM1 replyview on HN

The main reason drug development is so enormously expensive because the FDA makes it that way with their paranoid risk averse regulatory process and insanely restrictive requirements on what requires a doctor prescription.


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loegtoday at 3:08 AM

> 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.

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