The head of the U.S. Food and Drug Administration is considering using the agency’s powers to bring more price competition to the market for generic drugs, targeting high-priced products by prioritizing the approval of additional competing treatments.
FDA Commissioner Scott Gottlieb said in an interview Monday that the agency is looking at how to push applications to the front of the line in cases where there are fewer than three competing generic manufacturers. The policy would target cases where there are few or no competing versions of drugs, which has led to high prices in some situations.
In one now-infamous case, Turing Pharmaceuticals AG, then led by Martin Shkreli, bought the rights to sell a decades-old drug called Daraprim and raised the price to $750 a pill from $13.50. Valeant Pharmaceuticals International Inc. has likewise benefited from older drugs with limited competition, such as two treatments for the rare condition Wilson’s disease. Valeant bought the treatments and raised their prices by about 30-fold.
Adding generic competitors would mean lower prices, Gottlieb said. The goal is to have three manufacturers of every generic version of a drug. That’s the point at which prices start to fall significantly, he said…
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