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# Congressman Wants Insulin Omission Info from FDA
- URL: https://www.fdaweb.com/congressman-wants-insulin-omission-info-from-fda/
- Published: 2019-07-16T12:00:00.000Z
- Updated: 2026-09-15T01:38:07.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144541

Rep. **Mike Kelly** (R-PA), a diabetic and member of the Congressional Diabetes Caucus, is asking FDA for information on issues that may have contributed to it not listing insulin as a peptide drug product eligible for generic production in ANDA guidance issued 10/2017\. In a 7/16 [letter](https://kelly.house.gov/sites/kelly.house.gov/files/documents/Kelly%20Letter%20to%20FDA%20Regarding%20Availability%20of%20Generic%20Insulin.pdf?ref=fdaweb.com) to FDA acting commissioner **Ned Sharpless**, Kelly says one reason for the steady rise in the cost of insulin is “because the regulatory pathway for generic insulin production is currently inhibited for reasons I would like to know and address.”

The letter asks for detailed responses to two questions: 

- why FDA did not include insulin in the 10/2017 ANDA guidance for certain peptide drug products and whether there are safety, efficacy, or statutory barriers to its inclusion; and
- if there were statutory limitations preventing insulin’s inclusion, what legislative action is needed to remove the obstacles.

In a news release, Kelly [says](https://kelly.house.gov/press-release/kelly-fda-lack-generic-insulin-causes-hardship-millions-american-diabetics?ref=fdaweb.com) that if FDA had included insulin in its peptide drug ANDA 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 for all Americans.”