WASHINGTON — FDA Commissioner Scott Gottlieb blasted insulin makers Tuesday for what he called unacceptably high prices for a decades-old drug. And he rolled out a slate of new guidances for the industry he says will spur competition in the insulin market and bring down the drug’s cost when they take effect in 2020.

But in a speech at this week’s FDA/CMS Summit, Gottlieb stopped short of endorsing policies gaining steam on Capitol Hill that would dramatically change how insulin makers do business.

“We’ve heard frequent reports of patients rationing insulin, and in some cases dying because they can’t afford the injections they need to survive,” Gottlieb said Tuesday, according to prepared remarks shared with STAT. “These tragic stories aren’t isolated occurrences. And they’re not acceptable for a drug that’s nearly a century old.”

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Insulin is increasingly being held up by policymakers and drug pricing activists as an example of the human toll of high drug prices. Three companies — Eli Lilly, Novo Nordisk (NVO), Sanofi (SNY) Aventis — control 90 percent of the insulin market, and that lack of competition has led to escalating prices in recent years.

But that lack of competition is partially due to the way insulins have historically been regulated.

Insulins are biologic drugs, meaning they’re made from living cells. But they haven’t been regulated the same way. Neither have copycat or generic insulins, known as follow-on insulins, been regulated the same way as most copycat biologic drugs, known as biosimilars.

That’s set to change in 2020, when insulins will be regulated as biologics, and, thus, the copycats will be regulated the same way as biosimilars.

That transition was written into the 2009 Affordable Care Act, and Gottlieb expects it will lead to more competition and lower prices for patients. “This is a watershed moment for insulin products,” Gottlieb said Tuesday, about the 2020 transition.

Two of the new guidances flesh out how the FDA will regulate the copycat insulins after that transition.

The guidances explain, among other things, that insulin products will not be eligible for a lucrative 12-year exclusivity period, despite now being regulated as biologic products, which typically are protected from competition for 12 years.

While Gottlieb said these new policies “should help usher in a new era of competition for these products that’ll lead to lower prices and better access,” they do nothing to affect what patients are paying now. Instead, they mostly address wonky questions being mulled in drug industry board rooms, like what a company should do when it’s submitting an insulin application that the FDA isn’t likely to approve before 2020.

That might not placate activists and lawmakers, who increasingly are calling for drastic action to bring down the cost of insulin.

The Congressional Diabetes Caucus, for example, released a slate of policy ideas in November that included requiring insulin makers to report how they set their prices.

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  • What is really sad is the insurance lobbyist (CIGNA, being largest) are also getting rebates and savings and NOT passing it on to the insured. So, if you run it through your insurance who will pay 80% of the price and the price is 1400 dollars, you pay 280. HOWEVER, the insurance company got a discount on that 1400 that you are NOT TOLD about where they are charged 800 dollars, but you are still paying 20% of the higher price. That is wrong and INSURANCE LOBBYISTS are the biggest game in Washington D.C. CIGNA has the largest lobbyist group and is the most PRIVATE insurance company you can hardly look into. Change things! Children are born with this disease and parents are in a real situation that insurance companies like CIGNA need to stop cheating people.

    • This resembles a criminal conspiracy more than any meaningfull action. The American people are catching on.

    • CIGNA is paying $800.00 for your drug and you’re paying $280.00? Why are you complaining?

  • Another way is for our congress to approve retail purchasing of Canadian and other country drugs. All instances that I have used in this he past it is the very same drug made by same pharmaceutical. Most all of our flu vaccine comes from Great Britain.. our Drug stores buy from all over the world including India. Many of our major drug companies have factories in India. After all it’s not like Canada and other countries citizens are dropping dead from bad drugs. They control them also.
    We need congress to allow/force our insurance companies to reimburse us for these costs. It would be less expensive for them and less expensive for us. We would not reach that ‘donut hole’ as quick.

    • Three companies control the insulin market, one is a US company and the others are a Danish and a French company. This seems like more of a regulatory issue than a foreign-produced drug issue. That’s the government’s doing, both Congress and the FDA. We, and Canada have had problems with foreign produced drugs in the past. Foreign producers, like Sanofi, that submit to FDA regulation do sell their drugs here. Congress got involved before and had to backtrack, mucking up the original legislation partly due to the pressure from activists. This article points out those regulatory problems that help drive up the cost of drugs in the USA, and many of those regulatory requirements came at the insistence of drug-safety activists. As Chesterton observed, ““The Reformer is always right about what’s wrong. However, he’s often wrong about what is right.”

  • About a dozen companies could make insulin. These three make it exclusively because they have pay to play contracts with the PBMs excluding competition. Well known situation in the industry. Big Three PBMs and Big Four GPOs have safe harbor for secret kickback contracts. Take away the unsafe lucrative safe harbor and insulin goes from $600 per month to $25 per month. FDA is not permitted to discuss Middlemen contracts but that does not mean physicians and patients cannot discuss healthcare’s dirty little secret. Check out this four minute video and links at the bottom to learn more. Time to pull back the curtain and make healthcare affordable again.
    https://www.physiciansforreform.org/no-middlemen

  • This is really getting pathetic, of course Gotlieb has to clear any action with his industry insider buddies and the rest of the industry.

    • You mean the people that actually know what they are talking about? Or, should he rely on your opinion?

  • You can walk into Walgreens/CVS right now and buy a 10ml vial of regular or NPH human insulin for $25. This is absolute nonsense!

    • It appears you are not type 1 diabetic. Yes you can buy this very old fast acting insulin for $25 but it is NO comparison to novolog or Humalog, the fast acting insulin that 95% of type 1’s use to survive, that are over $300/vial and going up every month. And they also need long acting insulin, that this $25/vial doesn’t do. This is a VERY big deal for people with type 1, and if you had a child like I do with this disease you sure wouldn’t call it nonsense!

  • A creative Bypass option : some Americans should create a new corporation, that bulk-buys insulin in another country (where it WILL be cheaper, because Americans are getting ripped off). Do some lavish Fundraising Dinners for the rich Americans (whose taxes are so ridiculously low that they most certainly can afford huge donations, for a tax receipt anyway). The corp then provides the insulin FREE (for a large corporate tax receipt) to those who simply can’t help they happen to be Type 1 Diabetic. The whole scheme might break even. And having to make a choice between insulin and food is Ancient History (as it absolutely should be, in a “Developed Western Country”).

    • Two of the 3 companies with 90% of the insulin market are not American companies, one is Danish and one is French. Would you like to buy your insulin from China?

  • Insulin or any other drug that has been around “forever” should NOT barner exhorbitant profits for Big Pharma. My friend’s husband is taking a thalidomide- derived medication that costs $35,000! An outrageous price. The insurance company pays $14,000 (for now). Luckily(for now) there is no after charge to the patient.

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