Category: Pharma Industry

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188 Bipartisan House Members Urge HHS Action Against J&J’s ‘Unlawful’ 340B Rebate Proposal

September 27, 2024 William Newton, Associate Editor/Senior Writer Views

A bipartisan group of 188 House members sent HHS a letter urging action against J&J's 340B rebate proposal.

A bipartisan group of 188 House lawmakers urged the federal government Friday to “use every enforcement tool” at its disposal [...]

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HRSA to J&J: End 340B Rebate by Monday or Lose Access to Key Government Health Insurance Markets

September 27, 2024 William Newton, Associate Editor/Senior Writer Views

HHS and HRSA sent J&J a Sept. 27 letter that again threatened tough enforcement action against the drugmaker's 340B rebate proposal.

The federal agency overseeing the 340B program has doubled down on its threat to terminate Johnson & Johnson’s (J&J’s) access [...]

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High-Ranking HRSA Official Talks Genesis Decision, Drugmaker Audits During Rare Unscripted Q&A at Industry Conference

September 26, 2024 William Newton, Associate Editor/Senior Writer Views

Lisa Scholz interviewed HRSA's OPA Director Chantelle Britton at the MDRP Summit in Chicago.

A high-ranking federal regulator addressed the 340B patient definition and manufacturer audits during an unscripted Q&A session after a speech [...]

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Sanofi Imposes New 340B Contract Pharmacy Rule in Arkansas Following Legal Deal with State

September 26, 2024 William Newton, Associate Editor/Senior Writer Views

Sanofi implemented a new 340B contract pharmacy rule for certain Arkansas hospitals.

Sanofi is requiring Arkansas hospitals to prove they legally own 340B-priced drugs until they are dispensed at contract pharmacies after [...]

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State Contract Pharmacy Lawsuit Weekly Roundup: Updates in Maryland, Minnesota

September 26, 2024 Bella Czajkowski, National Correspondent Views

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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Sen. Cassidy’s Letters to Drug Manufacturers Welcomed by Drug Industry Trade Group, Draw Skepticism from 340B Provider Advocates

September 24, 2024 Bella Czajkowski and Shannon Young, National Correspondent Views

The drug industry and 340B program advocates offered mixed reactions Monday to a key senator’s latest inquiries into drugmakers’ contract pharmacy restrictions as part of an ongoing congressional probe of the drug pricing program.

The drug industry and 340B program advocates offered mixed reactions Monday to a key senator’s latest inquiries into drugmakers’ contract [...]

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CMS Publishes Final Rule on Medicaid Rebates with Significant 340B Implications

September 24, 2024 William Newton, Associate Editor/Senior Writer Views

CMS released a final rule for Medicaid rebates with new identifiers and definitions that impact the 340B program.

Federal regulators last Friday finalized a highly anticipated rule for the Medicaid Drug Rebate Program (MDRP) with new identifiers and [...]

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PhRMA, HHS Seek Continued Pause on 340B ADR Lawsuit

September 24, 2024 William Newton, Associate Editor/Senior Writer Views

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

September 23, 2024 William Newton, Associate Editor/Senior Writer Views

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

September 19, 2024 William Newton, Associate Editor/Senior Writer Views

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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