New Senate bill would speed up availability of generic insulin in the U.S

WRITTEN BY: Todd Boudreaux

On July 11, 2019, U.S. Senators Dick Durbin (D-IL), Kevin Cramer (R-ND), and Tina Smith (D-MN) introduced the Affordable Insulin Approvals Now Act , a bipartisan bill to speed up the approval process of generic insulin products in order to help lower costs of the life-saving drug.

In December 2018, then-FDA Commissioner Scott Gottlieb, M.D., released a statement detailing a handful of new guidances designed to increase competition and bring down prices across the insulin market, slated to take effect in 2020.

Though these guidances were meant to increase competition, they had the unintended consequence of potentially slowing down approval of generic insulins currently in production. According to a press release by Durbin’s office, the FDA’s “new guidance effectively creates an application termination cliff on March 23, 2020 — in which the FDA will automatically reject ‘generic’ insulin products that are in the approval pipeline during that time. As a result, this could delay approval of lower-cost insulin products for American patients.”

This new bill aims to fix this “termination cliff” by requiring the FDA to continue reviewing generic insulin applications after the agency’s currently planned March 2020 cut-off date.

In March 2019, Lilly Diabetes announced that they were releasing an authorized generic version of Humalog — Insulin Lispro — for half the list price of Humalog. Insulin Lispro is now available in pharmacies across the United States, and is viewed as the first of what could be several generic insulins coming to market over the next few years.

“More generic insulin in the market means lower costs for those in need. Our bill encourages competition and free market solutions to the rising cost of this life-saving drug,” said Cramer. The legislation is supported by Diabetes Patient Advocacy Coalition, the National Diabetes Volunteer Leadership Council, and Children with Diabetes.

This bill comes on the heels of another insulin pricing bill introduced by Senators Smith and Cramer. Just two weeks earlier the pair announced the ‘Emergency Access’ Bill to lower insulin costs. That legislation features the set-up of an emergency insulin assistance program, which would be funded in part by a fee imposed on insulin manufacturers who raise prices more than 10% in a year.

The introduction of these bills is a positive step at a time when insulin pricing is under more scrutiny that ever. It remains to be seen however — if and when these bills are enacted — what the real-world effects will be.

Earlier this week, the Trump administration withdrew their support of the “rebate rule”, a proposal touted for months that would help lower insulin costs for some. If passed, Medicare and Medicaid recipients would have seen rebates added into the upfront or “list price” of insulin, lowering what they pay at the pharmacy counter. These rebates are currently going to Pharmacy Benefit Managers (PBMs) who negotiate the prices between insurance companies and drug manufacturers.

The twisted semantics of these people is mind blowing.

" bipartisan bill to speed up the approval process of generic insulin products in order to help lower costs of the life-saving drug."

How about using real words that reflect reality. Speed up the approval process of simply putting a different label on the exact same **** ?

Its like re labeling water to its “generic version” of H2O and lowering the price but we have to have a vote and “approval process”

Mind blowing how corrupt the government and medical system is.

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While I have to agree that the system can be somewhat perverted we should not lose sight of the fact that this move is a good thing.

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This bill is not going to accomplish much if they don’t address the real problem, which is the cost of name brand insulin. Saying the generic will be half the cost does not solve anything when the name brand is $300-400 a vial and keeps increasing every year. They’re never going to stop giving all the money and power to the entities that are the root cause of most of our health care problems.

Okay, not to downgrade a plus in having a generic cheaper. But I can’t help thinking that the 50% reduction in cost is the cost that it was not so long ago in the first place? Were the huge increases just to protect their generic availability/pricing that is always going to happen after a certain amount of time?

I disagree.

This system needs a collective kick in the rear from all of us not appreciation that they take half a step forward every year only cause of the minimal prodding they get.

Read this book to understand the people we are dealing with.

Written by the two top experts on the subject. No joke, its these people running things. Only these kind of people can create and maintain the crooked system we have.

If you want to defeat the opposition its best to read up on how they operate.

Read the whole thing, then watch the next big senate hearing about prescription prices on C-Span and watch the behaviors.

The world and history are full of people for whom the world was against them. In those situations, its a practical matter of survival to focus on what can be done, as opposed to what cannot. However…

Some strategies developed when people tried to escape from the Gulag. I like the gulag example because the world didn’t know that the gulag existed for a long time. I don’t think most normal people have any idea about the circumstances that surround diabetics or other ‘sick’ people who rely of the healthcare system in the U.S.

So, in the gulag, people sometimes tried to escape in groups of 3. The group was 2 friends who had an alliance, and one guy who they secretly termed “the walking meat.” They had to cross vast territory on foot to reach Finland with no resources whatsoever. The 3rd guy was, unwittingly, the food.

Does anybody recall the Federal hearings this year where they kinda said that diabetics buy insulin, a very expensive drug, but a very predictable cost/supply of money entering the healthcare system to subsidize the rest of the system so that it doesn’t collapse?

They seemed to state, in unusually frankness, that diabetics are the walking meat. Along IgotT1’s strain of thinking, how big of a house of cards is this system? Efforts at reform have always seemed kinda pointless to me, unless they burn the whole system to the ground and start from scratch. Your never gonna reform the Gulag into a functioning state run enterprise.

To lighten the mood, here is a beautiful painting of women from the Soviet collective farms painted in the 60’s…looks reasonable enough, right? I always think of the woman in the middle as the diabetic - the walking meat.

Generic drug manufacturers aren’t the most ethical bunch (see link). They’re being reeled in by this lawsuit, but don’t count on them to look after our interests. There were also segments about this on 60 Minutes and CNN.

I go past the expiration date and keep using it till the vial is empty.

I suppose I am risking a bacterial infection. Bacteria likes to double 2 4 8 16 32 64 128 256 ect so I guess by day 28 the count can be rather high if some gets in the vial and that’s why they say to toss it and have an expiration date.

They T.H.E.Y (The Hierarchy Enslaving You) they don’t really care as long as they make their billions. No one is fixing the Rx price problem.

That comment was for the TV insulin rationing thread. How did it land on here ? Now I can’t even find that thread.

Edit > Here it is People are dying from insulin rationing – even tv dramas are talking about it

Maybe later post it in. Had to use the search. Confusing how these threads are sorted sometimes.

Pitch is world’s slowest -moving liquid. This droplet is part of whats known as the longest running scientific endeavor according to Guinness World Records.

I bet the drip drops before this senate bill goes anyplace.

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