Senators tell FDA to speed up approvals of generic insulin

Senators tell FDA to speed up approvals of generic insulin
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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 DurbinThreat of impeachment takes oxygen out of 2019 agenda Senate Democrats request watchdog, Red Cross probe DHS detention facilities Iraq War looms over Trump battle with Iran MORE (D-Ill.), Kevin CramerKevin John CramerTrump pushing for GOP donor's company to get border wall contract: report The Hill's Morning Report - Trump says no legislation until Dems end probes Bolton emerges as flashpoint in GOP debate on Iran MORE (R-N.D.), Bill CassidyWilliam (Bill) Morgan CassidyBipartisan senators reveal sweeping health care package Senate passes bill to undo tax increase on Gold Star military families Overnight Health Care — Presented by Campaign for Accountability — House passes drug pricing bills amid ObamaCare row | Senate Republicans running away from Alabama abortion law | Ocasio-Cortez confronts CEO over K drug price tag MORE (R-La.), and Tina SmithTina Flint SmithWhat if scientists, not politicians, called the shots on climate policy GOP Senate campaign arm hits battleground-state Dems over 'Medicare for All,' Green New Deal Hillicon Valley: Washington preps for Mueller report | Barr to hold Thursday presser | Lawmakers dive into AI ethics | FCC chair moves to block China Mobile | Dem bill targets 'digital divide' | Microsoft denies request for facial recognition tech 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.”

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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.