> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Fix Biologics Policy on Insulin: Senators
- URL: https://www.fdaweb.com/fix-biologics-policy-on-insulin-senators/
- Published: 2019-03-05T12:00:00.000Z
- Updated: 2026-09-15T01:09:54.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143531

A bipartisan group of four senators say recent FDA guidances aimed at facilitating development of lower-cost biosimilars may have the opposite effect for development of generic insulin. In a 3/1 [letter](https://www.durbin.senate.gov/imo/media/doc/Senate%20Letter%20to%20FDA%20on%20Insulin.pdf?ref=fdaweb.com) to FDA commissioner **Scott Gottlieb**, Sens. **Richard Durbin** (D-IL), **Tina Smith** (D-MN), **Kevin Cramer** (R-ND), and **Bill Cassidy** (R-LA) “urge FDA to quickly amend its recent guidance documents that pose unreasonable approval delays for insulin products that could help patients with diabetes.”

The senators review the significant increase in the price of insulin over the last 20 years and say that while they recognize there are myriad reasons for the price increases, “it remains unacceptable that — nearly a century after insulin was first discovered — there are no approved, lower-cost insulin products that can be substituted at the pharmacy level.”

They say there currently are no insulin reference products under the Public Health Services Act, which are required for submission of generic or biosimilar insulin applications. “The FDA guidance will facilitate the submission of applications for biosimilar insulin products for the first time,” the letter says. “Although these changes will bring new insulin products into market in 2020, the current regulatory framework still introduces perverse incentives that could delay the introduction of low-cost insulin products into the market in the short-term, when they are needed most.”

The four express concern that approved insulin follow-ons under the Federal Food, Drug, and Cosmetic Act will not transition to biosimilar licenses, meaning they can’t be substituted for branded versions by pharmacists. Also, they say, the guidance indicates that companies with 505 insulin applications in the FDA approval pipeline that are pending or tentatively approved on 3/23/20 will be rejected by FDA and the companies will have to start over with a new application under a different pathway and pay an additional user fee. “It is concerning that an application to bring a new or follow-on insulin to market would be rejected and forced to submit a new application, while FDA provides flexibility by planning to ‘administratively convert’ pending NDA supplements to pending BLA supplements,” they write. “If FDA has the ability to offer flexibility in one domain, recognizing the cumbersome requirement to withdraw and re-submit an application, then FDA should offer similar flexibility for pending and/or tentatively approved 505 insulin applications.”

The senators ask for information on **(1)** steps FDA is taking to expedite approval of insulin follow-on applications prior to the 3/23/20 deadline; **(2)** how many applications are currently pending; and **(3)** whether FDA anticipates approving any insulin follow-on applications before the 3/23/20 deadline.