PhRMA, HHS Seek Continued Pause on 340B ADR Lawsuit

HHS and PhRMA will continue to pause a lawsuit challenging the government's 340B ADR process.
A major drug industry trade group and the federal government have asked a federal judge to continue to pause litigation [...]

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Senator Cassidy Extends 340B Inquiry to Two Major Pharmaceutical Manufacturers

Sen. Bill Cassidy (R-La.) has extended an ongoing 340B probe to two major drug manufacturers.
An influential Republican senator this morning requested detailed information from Eli Lilly and Amgen on their 340B programs, including the [...]

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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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State Contract Pharmacy Lawsuit Weekly Roundup: AbbVie Asks 5th Circuit to Reverse Ruling, New Developments in Missouri and Kansas 

Key filings and orders occurred in lawsuits challenging the 340B contract pharmacy access law in Missouri.
Editor’s Note: With 340B-related litigation heating up in several states following the enactment of new contract pharmacy access laws, 340B [...]

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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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Sen. Welch Hopes His Contract Pharmacy Bill Will Move Soon, ASAP 340B and PhRMA Push for Broader Bill

The Senate version of the 340B PATIENTS Act faces hurdles to passage despite broad support from provider groups.
The sponsor of new Senate legislation that would codify providers’ ability to use contract pharmacies to dispense 340B discounted drugs [...]

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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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Eli Lilly and Amgen Announce Refunds, Amgen Issues NDC Change

Eli Lilly and Amgen announced refunds for 340B covered entities that purchased certain drugs in 2021.
Two drugmakers recently announced that they will refund 340B covered entities that purchased certain medications following adjustments to their ceiling [...]

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