Senators tell FDA to speed up approvals of generic insulin

Senators tell FDA to speed up approvals of generic insulin
© Getty Images

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 DurbinRichard (Dick) Joseph DurbinDemocrats pledge to fight Trump detention policy during trip to border Dems open to killing filibuster in next Congress Democrats warm to idea of studying reparations MORE (D-Ill.), Kevin CramerKevin John CramerTrump puts hopes for Fed revolution on unconventional candidate Trump nominees meet fiercest opposition from Warren, Sanders, Gillibrand Acosta on shaky ground as GOP support wavers MORE (R-N.D.), Bill CassidyWilliam (Bill) Morgan Cassidy2 Republican senators introduce resolution to label antifa as domestic terrorists Finding a path forward to end surprise medical billing Liberal think tank: GOP paid parental leave proposals are too narrow MORE (R-La.), and Tina SmithTina Flint SmithClean water or mining pollution for the nation's favorite wilderness? Hillicon Valley: House panel advances election security bill | GOP senator targets YouTube with bill on child exploitation | Hicks told Congress Trump camp felt 'relief' after release of Clinton docs | Commerce blacklists five Chinese tech groups Senate Democrats press regulators over reported tech investigations MORE (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.”

ADVERTISEMENT

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.