Teva files lawsuit against drug-price negotiations

 Teva files lawsuit against drug-price negotiations


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Teva Pharmaceuticals has joined other drug makers in filing a lawsuit against the Department of Health and Human Services for the drug-pricing provisions of the Inflation Reduction Act.

Teva filed the civil action on Wednesday in federal court in Washington, D.C. as the Centers for Medicare and Medicaid Services released the next 15 drugs subject to price negotiations.

At the top of the CMS list is Ozempic, Rybelsus and Wegovy, semaglutide drugs popular for weight loss made by Novo Nordisk.

Teva makes two on the CMS list: Austedo and Austedo XR, drugs used to treat symptoms of tardive dyskinesia and Huntington’s disease. 

Teva Pharmaceuticals also makes generic drugs and biosimilars such as acetaminophen and amoxicillin. 

WHY THIS MATTERS

Teva provides lower-cost alternatives to existing branded medicines and the inflation Reduction Act’s drug negotiation provision has disrupted competition, the lawsuit said.

“For this system to work, though, generics and biosimilars must be able to compete on price by charging substantially less than their branded counterparts, capturing market share in the process,” the lawsuit said. “Otherwise, no patients or payors would choose them, and generic and biosimilar manufacturers such as Teva would not recover their investments, which in turn fund the development of future generic and biosimilar competitors and their public health benefits. CMS has disrupted this process by forcing a generic or biosimilar manufacturer to compete with unlawful price controls rather than free-market prices.” 

While Teva said its position in making generic drugs gives it a singular perspective, it makes the argument that other manufacturers have that implementation of the IRA and the drug pricing program is unconstitutional, “upsetting the delicate balance between innovation and affordability …”

CMS has changed the statute and there is no negotiation with a drugmaker, just a take-it-or-leave-it demand, the lawsuit said.

“The IRA’s Drug Price Negotiation Program (DPNP) is a fiction. The statute empowers CMS to impose lower prices for Medicare’s top-spend medicines, even when generic or biosimilar alternatives are already likely to bring those prices down through free-market competition,” the lawsuit said. 

Among other requests Teva wants injunctive relief barring the federal government from applying the drug-pricing provisions of the IRA to Teva or to the manufacturers of branded drugs on biologics with which Teva competes.

THE LARGER TREND

Teva is among seven drug companies that have filed lawsuits against drug price negotiations, according to Patients for Affordable Drugs. 

“Teva Pharmaceuticals – like the seven other drug companies that have already filed lawsuits to undermine drug price negotiations – is fighting to protect windfall profits from Austedo and Austedo XR at the expense of patients who pay up to $14,642 for a one-month supply of these drugs,” said the organization.

Teva’s lawsuit hinges on the claim that two of its drugs with the exact same active ingredient should not both be subject to Medicare drug price negotiations at the same time, according to Merith Basey, executive director of Patients For Affordable Drugs.

Basey, said by statement: “Teva’s new lawsuit marks the 10th attempt from Big Pharma and its allies to block Medicare from negotiating lower drug prices for patients. These corporations are determined to restore their unfettered power to dictate prices to the people in America–the only nation on the planet that didn’t negotiate over prices of prescription drugs until the passage of the new drug price law in 2022.”

Of nine lawsuits filed as of March 2024, the pharmaceutical industry have not scored any victories, according to Center for Medicare Advocacy.

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Email the writer: SMorse@himss.org



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Fallon Wolken

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