1 March 2019 - 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.”

Read The Hill article