Category: Federal

AbbVie is 1st Drugmaker to Challenge Colorado’s New 340B Contract Pharmacy Access & Reporting Law

June 17, 2025 Shannon Young, Associate Editor/Senior Writer Views

AbbVie filed a June 12 lawsuit in federal court against the state of Colorado that challenges the constitutionality of that state’s contract pharmacy law.

A Chicago-based pharmaceutical giant recently urged a federal court to block Colorado’s contract pharmacy access law—marking the first drug manufacturer [...]

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Federal Appellate Court Fast-Tracks Drugmakers’ Appeal of 340B Rebate Ruling

June 12, 2025 William Newton, Associate Editor/Senior Writer Views

A federal appellate court in Washington, D.C. will hear two drugmakers' appeal of a lower courts 340B rebate ruling on an expedited schedule.

A federal appellate court in Washington, D.C. is fast-tracking Novartis and Bristol Myers Squibb’s (BMS) appeal of a lower court [...]

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CMS Offers New Details on Medicare Drug Price Negotiations, 340B Advocates Raise Concerns About Impact on Program

June 12, 2025 Shannon Young, Associate Editor/Senior Writer Views

340B stakeholders raised concerns about May 12 draft guidance on the IRA Medicare Drug Price Negotiation Program's “manufacturer effectuation of the maximum fair price in 2026, 2027 and 2028,” among other things.

The Centers for Medicare and Medicaid Services (CMS) released new details this week to help stakeholders navigate the Inflation Reduction [...]

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J&J, Lilly and GSK to Refund 340B Covered Entities for Overcharges

June 12, 2025 Shannon Young, Associate Editor/Senior Writer Views

Johnson & Johnson and two other major drugmakers recently announced refunds for 340B covered entities that purchased certain drugs in 2022 and 2023.

Three major drugmakers recently announced refunds for 340B covered entities that purchased certain drugs in 2022 and 2023 following recalculations [...]

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Cassidy Staffer, ASAP 340B Head Call for 340B Program Reforms, Comment on Proposed Shift to CMS

June 10, 2025 Shannon Young, Associate Editor/Senior Writer Views

Jeffrey Last, U.S. Sen. Bill Cassidy’s (R-La.) legislative lead on 340B, highlighted the findings and recommendations of the HELP Committee chairman’s late-April report on the 340B program at a June 4 webinar.

A key health policy staffer for U.S. Senate Health, Education, Labor and Pensions (HELP) Committee Chairman Bill Cassidy (R-La.) recently [...]

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Sandoz to Stop Notifying CEs of 340B Contract Pharmacy Changes, Joins Liquidia in Adding Restrictions to New Drugs; Novartis Updates Restrictions

June 10, 2025 Shannon Young, Associate Editor/Senior Writer Views

Sandoz announced in a June 4 notice to covered entities it “will no longer be providing additional notification for product changes to [its] contract pharmacy policy.”

Two drugmakers recently added new medications to the list of drugs subject to their respective 340B contract pharmacy restrictions—one of [...]

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In Emergency Motion, Novartis and BMS Urge Appellate Court to Fast-Track Their Appeals of 340B Rebate Ruling

June 5, 2025 William Newton, Associate Editor/Senior Writer Views

Novartis and BMS filed an emergency motion with the federal appeals court in Washington, D.C. to appeal a recent ruling on drugmaker 340B rebates.

Novartis and Bristol Myers Squibb (BMS) are asking a federal appeals court to expedite their challenge to a recent ruling [...]

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Premier Asks Court to Reject HRSA’s Defense of 340B Hospital Drug Purchasing Restrictions Policy, Requests Oral Arguments

June 5, 2025 Shannon Young, Associate Editor/Senior Writer Views

Premier again asked a Washington D.C. federal court to strike down a HRSA policy that restricts how certain 340B hospitals can purchase initial drug inventory.

A major group purchasing organization (GPO) recently urged a Washington D.C. federal court to reject the federal government’s defense of [...]

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State Contract Pharmacy Lawsuit Roundup: Drugmakers File Briefs in 5th Circuit Appeals Case, Updates in Utah and Nebraska

June 5, 2025 Shannon Young, Associate Editor/Senior Writer Views

Key briefs were filed in litigation on contract pharmacy access laws in Louisiana, Utah and Nebraska.

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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340B Stakeholders Offer Mixed Views on Trump’s Plan to Move Drug Pricing Program to CMS

June 3, 2025 Shannon Young, Associate Editor/Senior Writer Views

340B advocates and stakeholders offered mixed reactions to President Donald Trump's HHS budget request, which called for moving the 340B program to CMS.

340B stakeholders and attorneys offered mixed initial reactions this week to President Donald Trump’s proposal to move the 340B program [...]

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