Congressional Diabetes Caucus Chairs Hail FDA Insulin Guidance

Dec 11, 2018

Washington, DC -- Congressional Diabetes Caucus co-chairs Reps. Diana DeGette (D-CO) and Tom Reed (R-NY) issued the following statement after the FDA finalized guidance treating insulin as a biologic product:

"The FDA has taken an important step to bring new insulin producers to market and address the dramatic insulin price increases. Insulin remains essential for millions of diabetes patients, and it must remain accessible and affordable for every one of them. As we have investigated issues surrounding insulin prices, we specifically called for this action, and we commend FDA Commissioner Scott Gottlieb for his attention and follow-through."


  • Over the last year and half, Rep. DeGette and Rep. Reed have led the charge to lower insulin prices, which have doubled since 2012.
  • There are no biosimilar insulins on the market because the FDA did not have a clear regulatory pathway for approving biosimilars.
  • To address this issue, Reps. DeGette and Reed sent a letter to FDA on September 20, 2017, urging the agency to finalize a piece of guidance which would provide biosimilar insulin makers with an approval pathway.
  • Reps. DeGette and Reed also reiterated this call in their insulin inquiry report published on November 1, adding that this pathway should be streamlined and would help inject competition in the highly-concentrated insulin market.
  • Today, the agency finalized that guidance, giving biosimilar insulin makers a clear way to get cheaper insulin formulations to market.
  • This action will help bring competition into the insulin market, providing patients with cheaper/effective insulin alternatives and potentially helping bring down insulin prices