From Stat

Lilly Will Sell a Version of Its Popular Insulin at Half the Price, but Will This Appease Critics?

March 4, 2019

As drug makers come under increasing pressure to lower prices, Eli Lilly (LLY) is trying to thread a needle by introducing a new version of insulin at half the list price.

Specifically, the product is a so-called authorized generic version of the Humalog insulin, which means the medicine is identical to the brand-name treatment and will be made at the same plant, but carries a different label. Known as Lispro, the medication will sell for $137.35 a vial, while the list price of a five-pack of KwikPens will be $265.20.

As drug makers come under increasing pressure to lower prices, Eli Lilly (LLY) is trying to thread a needle by introducing a new version of insulin at half the list price.

Specifically, the product is a so-called authorized generic version of the Humalog insulin, which means the medicine is identical to the brand-name treatment and will be made at the same plant, but carries a different label. Known as Lispro, the medication will sell for $137.35 a vial, while the list price of a five-pack of KwikPens will be $265.20.

The move reflects growing anger at the pharmaceutical industry, although insulin has been a particular focal point among patients and, subsequently, lawmakers. The average list price for insulin nearly tripled between 2002 and 2013, according to the American Diabetes Association. More than 30 million Americans have some form of diabetes….

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A Year After Trump Touted ‘Right to Try,’ Patients Still Aren’t Getting Treatment

January 29, 2019

For Frank Mongiello, Jan. 30, 2018 was a day of hope. After dedicating the last few years of his life to the “right-to-try” movement, an effort to get dying patients access to experimental treatments, Mongiello heard President Trump use his first-ever State of the Union address to urge Congress to pass a federal law on the issue.

Just one year later, the law is in place. But Frank, who suffers from ALS — and for whom the national law is even named — still hasn’t gotten access to treatment.

For Frank Mongiello, Jan. 30, 2018 was a day of hope. After dedicating the last few years of his life to the “right-to-try” movement, an effort to get dying patients access to experimental treatments, Mongiello heard President Trump use his first-ever State of the Union address to urge Congress to pass a federal law on the issue.

Just one year later, the law is in place. But Frank, who suffers from ALS — and for whom the national law is even named — still hasn’t gotten access to treatment.

“We had a lot of hope that if the right to try was passed it would give an incentive for the drug companies to make available the drugs. But now it doesn’t seem as though the drug companies are giving away their drugs either,” Marilyn Mongiello, Frank’s wife, told STAT. She speaks for him in interviews because he is only able to communicate via technology that turns his eye movements into text. In a brief email exchange, Frank confirmed to STAT that he has not found treatment but that he remains optimistic, despite his worsening condition….

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Supreme Court seems unlikely to overhaul popular drug industry legal strategy

January 7, 2019

Several Supreme Court justices seemed to side with the drug industry in a case that examined a popular defense that companies use to ward off patient lawsuits.

They heard oral arguments Monday in a case that has high stakes for pharmaceutical companies, which often wriggle out of patient lawsuits by arguing that the Food and Drug Administration limits their ability to warn patients about the side effects of their medicines, therefore absolving them of responsibility to do anything other than exactly what the FDA mandates. Patients, on the other hand, want drug makers to be more explicit about the potential risks of their medicines and argue that state law supports them.

Several Supreme Court justices seemed to side with the drug industry in a case that examined a popular defense that companies use to ward off patient lawsuits.

They heard oral arguments Monday in a case that has high stakes for pharmaceutical companies, which often wriggle out of patient lawsuits by arguing that the Food and Drug Administration limits their ability to warn patients about the side effects of their medicines, therefore absolving them of responsibility to do anything other than exactly what the FDA mandates. Patients, on the other hand, want drug makers to be more explicit about the potential risks of their medicines and argue that state law supports them….

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Gottlieb blasts high insulin prices, touts far-off new rules he says will spur competition in that market

December 11, 2018

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.

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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With new drug pricing legislation, Grassley and Wyden hint at the next steps for a powerful Senate committee

December 4, 2018

A powerful, bipartisan pair of lawmakers introduced new legislation Tuesday that would give the government more power to make sure drug companies play by the rules of the Medicaid program.

A powerful, bipartisan pair of lawmakers introduced new legislation Tuesday that would give the government more power to make sure drug companies play by the rules of the Medicaid program.

It’s the first sign of how the duo, Sens. Chuck Grassley (R-Iowa) and Ron Wyden (D-Ore.) intends to use their respective perches at the Senate Finance Committee to lower drug prices. Grassley will chair the committee beginning in January, and Wyden is already its top Democrat. The committee has jurisdiction over Medicare and Medicaid, including oversight of most of the Trump administration’s work to date on the issue of drug prices….

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