Kelly to FDA: Lack of Generic Insulin Causes Hardship for Millions of American Diabetics

Jul 16, 2019 Issues: Health Care

Washington, D.C. – Today, U.S. Representative Mike Kelly, R-Pa., sent a letter to the United States Food and Drug Administration (FDA) regarding the ever-increasing cost of insulin, a scenario that is harming the over 30 million diabetics in the United States. Kelly, a member of the Congressional Diabetes Caucus and a diabetic himself, said in the letter that the price increase has been caused by, at least in part, a lack of generic insulin on the market.

The average annual cost of insulin for a person with type 1 diabetes has reached $5,705, a 600% increase since 2001,” he wrote. “As insulin prices rise, Americans struggle to find affordable alternatives.” He continued: “American diabetics, tens of thousands of whom live in Pennsylvania’s 16th Congressional District, would benefit from the availability of a generic insulin.

Kelly requested information from the FDA on what issues may have contributed to the agency not listing insulin as a peptide drug product eligible for generic production in ANDA (abbreviated new drug application) guidance issued by the agency in October 2017. Had the FDA done so, 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 for all Americans.

The full letter can be read here.


Insulin was first discovered in 1921. After nearly a century, there are only three companies that manufacture the drug while the number of people requiring it has increased exponentially. In recent years, U.S. generic drug manufacturers have developed the technology and expertise to synthesize exact copies of insulin to be offered as a cheaper generic alternative, but regulatory limitations have been a roadblock to these companies entering the market. Further complicating the issue is implementation of the Biologics Price Competition and Innovation Act of 2009. In accordance with that law, insulin will be removed from the FDA’s list of approved drug products (the Orange Book) and reclassified as a biological product (in the Purple Book) on March 20, 2020, which will render it impossible for manufacturers to obtain approval for generic insulin and force the FDA to reject all such products already in the approval pipeline at that time. After the 2020 transition, companies wishing to make generic insulin will instead have to enter an altogether new application process for “biosimilar insulin,” a different product under an entirely new system.