Three Drug Makers Answer HRSA’s 340B Contract Pharmacy Letters Defiantly

Lilly, Novartis, and Sanofi sent HRSA defiant responses to its May 17 letters telling the companies that their 340B contract pharmacy policies were illegal.

On May 17, the federal government told six drug companies that their 340B contract pharmacy policies were illegal, and it asked them to provide updates by June 1 on their plans to comply with the law.

At least three of

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DOJ Says Lilly and Novo Nordisk’s 340B Actions Cost Providers Over $125 Million a Month and Hurt Patients

The New York Times has filed suit in the U.S. District Court for the Southern District of New York against the Health Resources and Services Administration to obtain an order requiring the production of 340B-related records requested in November 2023 under the Freedom of Information Act.

Drug manufacturers Eli Lilly and Novo Nordisk’s denials of 340B drug discounts when covered entities use contract pharmacies are causing entities to lose more than a combined total of $125 million per month in 340B program savings, federal filings in

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Pharma’s 340B Contract Pharmacy Limits Are Costing Providers $3.2 Billion a Year, DOJ Tells Court

Covered entities' monthly 340B savings on Sanofi products dropped from $54.2 million just before the company limited discounts on drugs shipped to contract pharmacies to about $5 million within two months, federal lawyers told a judge last week.

Hospitals, health centers, and clinics are losing a projected $3.2 billion a year in 340B program savings due to six drug manufacturers’ denials of 340B pricing on drugs shipped to contract pharmacies, the federal government said in a court filing

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DOJ and AstraZeneca Far Apart on How Company’s Lawsuit Should Proceed

AbbVie and AstraZeneca filed a pair of lawsuits to block Minnesota's law barring manufacturer 340B contract pharmacy restrictions.

Drug manufacturer AstraZeneca and the federal government are miles apart on what a federal judge should do next after ruling last week that the government had no basis for stating in December that the 340B statute unambiguously requires manufacturers to

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DOJ Asks Judge to Toss PhRMA Suit Against 340B Dispute Resolution System and Audit Guidelines

The federal government has asked a judge to dismiss PhRMA's legal challenge to the 340B administrative dispute resolution final rule and guidelines governing drug manufacturer audits of 340B covered entities.

The U.S. Justice Department (DOJ) has submitted a blistering motion asking that a lawsuit filed by Pharmaceutical Research and Manufacturers of America (PhRMA) to strike down the new 340B program administrative dispute resolution (ADR) process be tossed out of court.

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Government Notifies Drug Companies About 340B Contract Pharmacy Advisory Opinion’s Withdrawal

The federal government notified drug makers on Friday about its withdrawal of its 340B contract pharmacy legal advisory opinion. | Shutterstock

The federal government notified drug makers Lilly, Novo Nordisk, and Sanofi in court papers on Friday about its withdrawal of its 340B contract pharmacy legal advisory opinion, in connection with AstraZeneca’s contract pharmacy lawsuit. It said the withdrawal does not

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Breaking News

BREAKING: HHS Withdraws 340B Contract Pharmacy Advisory Opinion, and Becerra Appoints 340B Dispute Resolution Board Members

HHS yesterday withdrew its ex-General Counsel Robert Charrow's legal advisory opinion that the 340B statute requires drug companies to offer 340B pricing when covered entities use contract pharmacies.

HHS Withdraws 340B Contract Pharmacy Advisory Opinion, Says May 17 Demand Letters Are Unaffected

The U.S. Health and Human Services Department (HHS) yesterday withdrew its December 2020 legal advisory opinion (AO) that the 340B statute unambiguously requires drug manufacturers to

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340B Entity Groups Accentuate Positives in 340B Contract Pharmacy Court Opinion

The 340B statute “is silent as to the role that contract pharmacies may play in connection with covered entities’ purchases of 340B drugs," a judge ruled Wednesday in a suit filed by AstraZeneca.

Groups representing 340B covered entities are emphasizing the positives in what they say was a federal judge’s otherwise disappointing opinion Wednesday on whether drug makers must offer 340B ceiling prices when covered entities use contract pharmacies.

The groups’ message is,

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Supreme Court Preserves ACA and, with it, the Health Care Reform Law’s 340B Provisions

340B hospital challenge to Medicare Part B reimbursement could reverse long-standing legal doctrine.

The U.S. Supreme Court ruled 7-2 this morning that Texas and a dozen other Republican-led states lacked standing to challenge the constitutionality of the Affordable Care Act.

In addition to expanding health insurance to 21 million Americans, the ACA included

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BREAKING: Judge Hands HHS Major Setback in AstraZeneca’s 340B Contract Pharmacy Lawsuit

U.S. District Judge Leonard Stark today rejected HHS's conclusion that the 340B statute requires drug makers to offer 340B pricing when covered entities use contract pharmacies.

A federal district judge ruled today that the U.S. Health and Human Services Department’s (HHS) position that the 340B statute requires drug manufacturers that participate in the 340B program to offer discounts on drugs dispensed by contract pharmacies “is not

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