Why this Matters
The plaintiff argues that certain agency enforcement and regulatory actions requiring drug manufacturers to offer discounted prescription drugs to contract pharmacies under the 340B Drug Pricing Program without the ability to impose any sales conditions violate the Appointments Clause and the Administrative Procedure Act. The growth of the 340B program and practices by certain providers and contract pharmacies have raised concerns about oversight and abuse of the program—to the tune of billions of dollars. This appeal addresses whether the district court erred in granting the defendants’ motion for summary judgement and finding that the defendants did not violate the Administrative Procedure Act.
Potential Impact
Requiring drug manufacturers to offer discounted prescription drugs to certain contract pharmacies under the 340B Drug Pricing Program would remove one avenue to combatting potential abuse of the program.
Sanofi-Aventis U.S., LLC v. Department of Health & Human Services et al.
Goal
Issues
Case History
Litigation Content
Why this Matters
The plaintiff argues that certain agency enforcement and regulatory actions requiring drug manufacturers to offer discounted prescription drugs to contract pharmacies under the 340B Drug Pricing Program without the ability to impose any sales conditions violate the Appointments Clause and the Administrative Procedure Act. The growth of the 340B program and practices by certain providers and contract pharmacies have raised concerns about oversight and abuse of the program—to the tune of billions of dollars. This appeal addresses whether the district court erred in granting the defendants’ motion for summary judgement and finding that the defendants did not violate the Administrative Procedure Act.
Potential Impact
Requiring drug manufacturers to offer discounted prescription drugs to certain contract pharmacies under the 340B Drug Pricing Program would remove one avenue to combatting potential abuse of the program.
News And Analysis (1)
O'NEILL INSTITUTE
Third Circuit Issues Major Decision That Could Shift 340B Landscape22 Major Filings
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MANDATE (Apr 25, 2023)
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OPINION (Jan 30, 2023)
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SUMMARY of Oral Argument Appellants (Oct 26, 2022)
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SUMMARY of Oral Argument Appellee (Oct 26, 2022)
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OPENING BRIEF Appellants (Jul 14, 2022)
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REPLY BRIEF for Appellants and Cross-Appellee (Jul 14, 2022)
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PRINCIPAL AND REPLY BRIEF Appellants (Jul 7, 2022)
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REPLY BRIEF Appellants (Jul 7, 2022)
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REPLY BRIEF Appellants (Jun 29, 2022)
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REPLY BRIEF Appellee (Jun 8, 2022)
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AMICUS BRIEF American Hospital Association et al (May 17, 2022)
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AMICUS BRIEF National Association of Community Health Centers et al (May 16, 2022)
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AMICUS BRIEF State of Connecticut et al (May 16, 2022)
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BRIEF Appellee (May 9, 2022)
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ORDER Consolidating Cases (Apr 28, 2022)
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ORDER Granting Extension of Time (Mar 28, 2022)
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MOTION for Extension of Time to file Def Brief (Mar 22, 2022)
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AMICUS BRIEF AstraZeneca Pharmaceuticals LP (Mar 15, 2022)
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AMICUS BRIEF Kalderos Inc (Mar 15, 2022)
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BRIEF Appellants (Mar 8, 2022)
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NOTICE of Appeal (Dec 29, 2021)
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ORDER Setting Briefing Schedule (Dec 29, 2021)
View MoreRelated Litigation
Litigation Information
Current Status
Decision issued
Legal Issues
Appointments Clause, Administrative Procedure Act - Contrary to Law, Administrative Procedure Act - Arbitrary and Capricious, Administrative Procedure Act - Notice and Comment Violation, Administrative Procedure Act - Contrary to Constitutional Right, Administrative Procedure Act - Lack of Statutory Authority
Litigation Metadata
AstraZeneca Pharmaceuticals LP; Kalderos, Inc.
State of Connecticut et al.; National Association of Community Health Centers et al.; American Hospital Association et al.