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Apr 30, 2019
ssc
23 min 2,878 words 486 comments podcast
Scott Alexander analyzes how FDA regulations contribute to drug shortages and high prices, using buspirone and insulin as examples. Longer summary
Scott Alexander discusses two issues in the pharmaceutical industry: the buspirone shortage and high insulin prices. He argues that both problems stem from regulatory issues, particularly FDA policies that inadvertently encourage monopolies and make it difficult for generic manufacturers to enter the market. For buspirone, the Generic Drug User Fee Amendments (GDUFA) of 2012 and 2017 have created a fee structure that favors large-scale monopolies. For insulin, the complex nature of biologics and the FDA's stringent approval process for biosimilars make it extremely difficult and expensive to produce generic versions. Scott criticizes the tendency to blame these issues on the free market, arguing instead that poorly designed regulations are the root cause. Shorter summary