A Cure for Swelling Drug Prices: Competition” (WSJ) explains how the FDA limits competition by delaying approval for sale of drugs approved as safe in other countries:

If the U.S. allowed the sale of drugs that regulators in other advanced countries have already approved, it would expose would-be monopolists to many more potential competitors.

….High prices should be a magnet for new suppliers. But first, generic manufacturers must prove to the Food and Drug Administration that their drug has the same quality, strength, purity and stability as the branded drug. That can be costly and time-consuming. The FDA has faced a growing volume of applications. More than 3,000 filed before October 2014 still await approval; the typical lag between application and approval is four years, according to the Generic Pharmaceutical Association, a trade group.

….[I]n Europe, EpiPen competes with several devices at a fraction of its U.S. list price of $608.61 per pair. Denmark’s ALK-Abello, which specializes in allergy therapies, sells the Jext pen for $34 to $67 throughout Europe, and is interested in selling it in the U.S. “Our decision will be determined by what it takes to obtain FDA approval,” says a spokesman.

….The FDA has long insisted, for safety reasons, that it approve all drugs regardless of whether they have been approved overseas. […] Ken Kaitin, a professor of medicine at Tufts University who has studied drug regulation around the world, says there is “absolutely no evidence” the U.S. drug supply is safer than in Britain, Canada or Europe.


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