Senators tell FDA to speed up approvals of generic insulin

A bipartisan group of senators want the Food and Drug Administration (FDA) to change its policy in order to speed up approvals of lower-cost, generic insulin products.

Sens. Dick Durbin (D-Ill.), Kevin Cramer (R-N.D.), Bill Cassidy (R-La.), and Tina Smith (D-Minn.) urged the agency amend a recent guidance that they said poses “unreasonable approval delays for insulin products that could help patients with diabetes.”

According to the lawmakers, a 2018 FDA guidance meant to ease the approval pathway for lower-cost “biosimilar” products instead creates a “perverse incentive that could delay approval of generic insulin.”{mosads}

The guidance will bring new insulin products into market in 2020, but the current regulatory framework could delay the introduction of low-cost insulin products into the market in the short-term, when they are needed most, the senators wrote.

Insulin was first discovered in 1921, and has remained largely unchanged. However, the price of insulin today is subject to anti-competitive practices and constant increases, the senators said.

There are only three insulin manufacturers in the U.S., and the price of insulin has doubled on average from 2012 to 2016. About 7.5 million Americans rely on insulin to manage their blood sugar levels, and it is essential to their survival.    

“We recognize there are myriad reasons for the significant insulin price increases, including limited competition, exploitation of the patent system, the opaque role of pharmacy benefit manager rebates, product improvements and variance over time, and a lack of transparency,” the lawmakers wrote.

“However, 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,” the senators said.