HRSA’s Enforcement Threats Against J&J’s 340B Rebate Proposal Could Face Drugmaker Challenge

Attorneys are mixed on the strength of J&J's legal case if it chooses to challenge HRSA's opposition to its 340B rebate proposal in court.
The federal government’s recent threat to penalize Johnson & Johnson (J&J) for its unapproved 340B rebate model could spark a [...]

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Federal Judge Upholds Four Drugmakers’ 2021 Contract Pharmacy Restrictions—Without Addressing ‘40-Mile Radius’ Rule

A federal district judge upheld four drugmakers' contract pharmacy restrictions as implemented in 2021.
A federal district judge ruled that four drugmakers’ 340B contract pharmacy restrictions—as implemented in 2021—do not violate the 340B statute, [...]

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Breaking News

HHS to J&J: End 340B Rebate Proposal Immediately or ‘Face Potential Consequences’—Including Termination from Federal Health Insurance Programs

HHS sent J&J a Sept. 17 letter demanding the drugmaker "immediately" cease its plan to implement a 340B rebate model.
The federal agency that oversees the 340B program today formally warned Johnson & Johnson (J&J) that it must “cease implementation [...]

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Fourth Hospital Sues HRSA for Alleged ‘Unlawful’ Authorization of J&J 340B Program Audits

Children’s National Medical Center sued HRSA for approving a drugmaker's 340B audit request.
A Washington, D.C.-based children’s hospital has sued the federal government for authorizing drugmaker Johnson & Johnson (J&J) to perform “unlawful” [...]

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Diabetes Drugmakers Urge Federal Appeals Court to Dismiss Health Centers’ 340B Antitrust Lawsuit

Sanofi and three other diabetes drugmakers are urging a federal district court to dismiss 340B antitrust allegations against them.
Four diabetes drugmakers are urging a federal appeals court to uphold a lower court’s decision to dismiss 340B antitrust claims [...]

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HHS Concessions in Contract Pharmacy Lawsuits Unlikely to Signal Shift in 340B Rebate Stance, Attorneys Say

The federal government is moving to resolve four contract pharmacy lawsuits, but may continue fighting Kalderos' 340B rebate model in court.
The federal government is likely to continue opposing 340B rebate models even as it moves to resolve four separate contract [...]

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Exclusive

Arkansas Plans to Challenge J&J’s Contested 340B Rebate Proposal for Violation of State Law

J&J said its 340B rebate proposal will apply to Arkansas covered entities.
Arkansas plans to challenge Johnson & Johnson’s (J&J’s) 340B rebate proposal for violating the state’s law barring drugmaker contract pharmacy [...]

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In Another Drug Industry Setback, Maryland Federal Judge Rejects Bids to Block State’s 340B Contract Pharmacy Access Law

A federal district judge in Maryland denied multiple drug industry motions in a contract pharmacy lawsuit.
A Maryland federal district judge has denied four separate drug industry attempts to block the state’s contract pharmacy access law—marking [...]

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HHS Asks D.C. Federal Court to Rule for Drugmakers in Contract Pharmacy Lawsuits, Ties Outcomes to Kalderos 340B Rebate Case

HHS filed status reports in five separate ongoing drug industry cases before a federal district court.
The U.S. government is asking a federal district court in Washington, D.C., to rule for drugmakers in four separate lawsuits [...]

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Merck Offers Refunds to 340B Providers for Overcharges of Inhaler in Fourth Notice This Year

Drugmaker Merck announced it will refund 340B covered entities for certain overcharges.
Pharmaceutical manufacturer Merck has announced it will refund 340B covered entities for certain overcharges of its inhaler, Proventil HFA, during [...]

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