STAT scooplet: Could there be a true generic insulin?

Rep. Mike Kelly (R-Pa.) wants answers from the FDA on why there isn’t a generic insulin. In a new letter sent this morning to Acting FDA Commissioner Ned Sharpless, which was shared exclusively with STAT, he’s taking issue with an obscure 2017 guidance that lays out how generic drug makers can copy certain peptide products. More specifically, he wants to know why insulin, which is a peptide, wasn’t included in that guidance.

Generic drugs can be automatically switched for brand drugs at the pharmacy counter, but that’s not been possible for insulins. Instead of filing generic drug applications for cheaper insulins (known in FDA-speak as ANDAs), drug makers have been forced to file applications called 505(b)(2)s, which don’t allow the same type of pharmacy substitution. Kelly says that’s part of the reason insulin prices are so high. 

“As a diabetic who uses insulin every day, I understand their challenges personally,” Kelly told me in a written statement. “If American innovators can produce a real generic alternative that brings insulin prices down, then we need to explore that option. From the looks of it, the technology is there but an FDA pathway is not. Americans deserve to know why.”

The situation is all the more pressing given insulins will soon be regulated biologics, meaning it’ll be even harder for pharmacists to substitute them in the drugstore. That pending transition has caused some hand-wringing in Congress, so much so that Sen. Dick Durbin (D-Ill.) introduced a bill last week requiring FDA to continue reviewing insulin applications even after that timeline. (Durbin’s bill, however, would not solve the issue perplexing Kelly.)