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

AstraZeneca and the federal government are miles apart on what a federal judge should do next in the company's 340B contract pharmacy lawsuit.

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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Two Closely Watched 340B Lawsuits Will Soon Get a New Judge

U.S. District Judge Ketanji Brown Jackson, the judge assigned to two closely watched 340B-related lawsuits, has been elevated to the U.S. Court of Appeals for the District of Columbia Circuit.

In a 53-44 vote, the U.S. Senate yesterday confirmed President Biden’s nomination of Ketanji Brown Jackson, the federal district judge who has been assigned to two closely watched 340B-related lawsuits, for a seat on the U.S. Court of Appeals for

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Bristol Myers Squibb/Celgene Myeloma Drugs: Patient-Safety or Profit Motive? Part 6

Our six-part investigative series takes an in-depth look into a question often asked by 340B providers: Why can’t they access 340B pricing on one of Bristol Myers Squibb/Celgene’s most profitable drug products? We also delve into serious fraud allegations, Congressional oversight, and the possibility of a renewed focus on this contentious area under new leadership at the U.S. Health and Human Services Department. Throughout the series, we also provide BMS/Celgene's viewpoint, their justification for their drug pricing practices, limited distribution policies and why they believe they are following the law.

Part 6 of 6—What Happens Next For Revlimid, Pomalyst, Thalomid, and 340B?

As we described in Parts 2 and 3 of this series, in 2018, an ex-Celgene vice president responsible for the company’s 340B program compliance alleged in a whistleblower

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Bristol Myers Squibb/Celgene Myeloma Drugs: Patient-Safety or Profit Motive? Part 5

Our six-part investigative series takes an in-depth look into a question often asked by 340B providers: Why can’t they access 340B pricing on one of Bristol Myers Squibb/Celgene’s most profitable drug products? We also delve into serious fraud allegations, Congressional oversight, and the possibility of a renewed focus on this contentious area under new leadership at the U.S. Health and Human Services Department. Throughout the series, we also provide BMS/Celgene's viewpoint, their justification for their drug pricing practices, limited distribution policies and why they believe they are following the law.

Part 5 of 6—Revlimid “didn’t get any better…. You just got better at making money”

Last September, the Democratic-controlled U.S. House Oversight and Reform Committee released a 45-page report focused on Celgene and Bristol Myers Squibb’s (BMS’s) nearly two

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