Lawmaker Asks FDA Why Insulin Isn’t Regulated as A Complex Generic

July 26, 2019

Rep. Mike Kelly (R-Pa.) has asked acting FDA Commissioner Ned Sharpless on why the FDA doesn’t consider insulin to be a complex generic drug — a change that would help boost competition and lower prices.

Kelly asked Sharpless in a letter to explain the agency’s thought process in not listing insulin as eligible for generic production in its October 2017 ANDA guidance.

Had the FDA included insulin in the guidance, “it could have opened the door to the domestic production of generic insulin, resulting in unprecedented competition in the insulin market, making it more accessible and affordable,” he said.

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