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SB 1179

Health: pharmaceuticals; drug manufacturers from engaging in certain conduct with pharmacies participating with a 340B program; prohibit. Amends 1978 PA 368 (MCL 333.1101 - 333.25211) by adding sec. 17757c.

2023-2024 Regular Session Introduced by Sam Singh

Prohibits denying or limiting access to 340B drugs by manufacturers, wholesalers, or brokers for 340B entities and their contracted pharmacies.

referred to Committee on Government Operations
#health:pharmaceuticals #stateagencies(existing):licensingandregulatoryaffairs
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WeVote Research Nonpartisan
Bill Summary · SB 1179

Summary — SB 1179 (Michigan): Prohibiting 340B drug access limitations; reporting requirements

Sponsor: Sen. Sam Singh (Senate substitute S‑5)
Subject: Public Health Code — pharmacy practice and drug control (adds MCL 333.17757c)

Main purpose

SB 1179 is designed to protect federally authorized 340B entities and the pharmacies they contract with from efforts by drug manufacturers, wholesalers, or wholesale distributor‑brokers to deny, limit, condition, or otherwise restrict access to drugs sold under the federal 340B Drug Pricing Program. The bill also establishes annual reporting requirements for 340B entities and for manufacturers of drugs with large price increases.

Key provisions

  • Prohibition on restricting 340B access (proposed MCL 333.17757c):

    • A manufacturer, wholesaler, or wholesale distributor‑broker may not deny, restrict, prohibit, condition, discriminate against, or otherwise limit:
    • the acquisition of a “340B drug” by a “340B entity”; or
    • the acquisition of, or delivery of, a 340B drug to a pharmacy under contract with or authorized by a 340B entity to receive drugs on the entity’s behalf.
    • Prohibits designating another person to engage in the prohibited conduct.
    • Exception: conduct otherwise authorized by Michigan or federal law is permitted.

  • Annual reporting by 340B entities (beginning July 1, 2026; each July 1 thereafter):

    • Must submit to the Department of Licensing and Regulatory Affairs (LARA) and to House and Senate fiscal agencies:
    • entity name; copy of annual 340B recertification; community health needs assessment (if required); affidavits of compliance with specified federal 340B requirements and audits; description of any adverse 340B audits in the prior 12 months; description of the program’s impact on patients/community.
    • LARA must post reports on its publicly accessible website.

  • Annual reporting by manufacturers (beginning July 1, 2026; each July 1 thereafter):

    • For any prescription drug that costs more than $40 per course of treatment and whose wholesale acquisition cost (WAC) rose by >15% in the prior 12 months, manufacturers must report:
    • manufacturer and drug name; brand/generic/biologic status; year introduced; WAC history (including at introduction and 5‑year schedule); estimated cost to produce one course of treatment; patent expiration date; dispensing forms.
    • LARA must post these reports publicly.

Who is affected

  • 340B entities (federally qualified health centers, certain hospitals and safety‑net providers covered under 42 USC 256b)
  • Pharmacies authorized/contracted to dispense 340B drugs on behalf of 340B entities
  • Drug manufacturers, wholesalers, and wholesale distributor‑brokers doing business in Michigan
  • LARA and the legislative fiscal agencies (administrative duties to receive/post reports)

Timeline and procedural notes

  • Reporting requirements take effect July 1, 2026 (annual reports thereafter).
  • The bill includes a contingency: it does not take effect unless Senate Bill No. 952 of the 102nd Legislature is enacted.
  • Sponsor and committee history: introduced in the Senate (Sen. Sam Singh); substitute S‑5 was passed by the Senate (Dec. 13, 2024) and the bill was referred to the Committee on Government Operations. A companion House bill is HB 2824.

Fiscal impact

Nonpartisan analyses indicate little to no fiscal impact on state or local government. Some minimal administrative costs are possible for 340B entities (preparing reports) and for LARA (posting reports).

Notes / limitations

  • Definitions reference federal law: “340B drug” (42 USC 1396r‑8) and “340B entity” (42 USC 256b).
  • The bill text does not specify an enforcement mechanism (civil penalties or private right of action) beyond the statutory prohibition and reporting obligations.

Compiled from official sources — confirm details with the bill’s official record.

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