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 DurbinSenate Dems petition Saudi king to release dissidents, US citizen GOP moves to rein in president's emergency powers Senate votes to confirm Neomi Rao to appeals court MORE (D-Ill.), Kevin CramerKevin John CramerOn The Money: Trump reverses North Korea sanctions imposed by Treasury | Trump to nominate Stephen Moore to Fed | Monthly deficit hits record 4 billion | IRS expands penalty relief for taxpayers Overnight Health Care: Dems demand answers on rule targeting Planned Parenthood | Senators tell FDA to speed approval of generic insulin | Nearly 8 in 10 say drug prices are 'unreasonable' in new poll Senators tell FDA to speed up approvals of generic insulin MORE (R-N.D.), Bill CassidyWilliam (Bill) Morgan CassidySenators ask CBO to review options for preventing surprise medical bills Five things to watch for in Trump's 2020 budget Overnight Health Care - Presented by Kidney Care Partners - FDA chief Scott Gottlieb resigns | House Dems to take up drug pricing bills next week | Planned Parenthood, doctors group sue over Trump abortion rule MORE (R-La.), and Tina SmithTina Flint SmithBooker takes early lead in 2020 endorsements Ex-Bush ethics chief calls for Steve King expulsion after he posted meme of potential civil war The Hill's 12:30 Report: Manafort sentenced to total of 7.5 years in prison 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.