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Bill Summary · HB 892

Overview

  • Bill: HB 892
  • Session: 136th (Ohio)
  • Title: Ohio-Made Prescription Drug Act (no separate title provided in the text)
  • Purpose: Establish the Ohio-made medicine manufacturing program to improve affordability, distribution, manufacture, purchase, and sale of generically equivalent drugs in Ohio.

Main purpose and intent

  • Create a state-led program to make essential generically equivalent drugs more affordable and accessible.
  • Promote competition, reduce costs for public and private purchasers, taxpayers, and consumers.
  • Encourage distribution, manufacture, or purchase of generically equivalent drugs within Ohio, prioritizing in-state access when feasible.

Key provisions and changes

  • Establishment

    • Create the Ohio-made medicine manufacturing program within the Department of Administrative Services (DAS), with health and development departments providing health, economic development, and business support expertise.
    • Aimed to be established within 60 days after the section’s effective date.
  • Administration and partnerships

    • An administrator will be jointly appointed by the DAS, Department of Health, and Department of Development; can hire staff as funding allows.
    • The administrator can form partnerships with payers, state agencies, group purchasing organizations, nonprofit corporations, or other third-party entities to distribute, manufacture, purchase, or sell generically equivalent drugs.
    • Partnerships may involve contractual arrangements to improve competition, lower prices, address shortages, and expand patient access.
    • A prioritized list of generically equivalent drugs will be developed and governed by the administrator, with prices set for drugs purchased or sold through partnerships.
  • Drug listing and pricing

    • The administrator will develop a list of generically equivalent drugs to be distributed, manufactured, purchased, or sold under partnerships.
    • Price setting for these drugs will be conducted by the administrator, considering factors such as FDA user fees, acquisition costs amortized over five years, rebates (to the extent allowed by federal/state law), total contracting and production costs, manufacturer R&D costs amortized over five years, and other startup costs amortized over five years.
    • Drugs shall be offered at a transparent price with no rebates beyond those required by federal law; priority for in-state providers/patients if supply is constrained.
    • No obligation for individuals or entities to purchase from the administrator or partners.
  • Evaluation and governance requirements (D and E)

    • Before entering partnerships, the administrator must assess legal, market, policy, and regulatory factors for viability.
    • Establish minimum purchasing volume thresholds over multi-year periods.
    • Partnerships require a reasonable determination that they meet program purposes and must be auditable (records maintained).
    • Partnering entities must be registered with the FDA as drug manufacturers or operators.
  • Drug selection criteria (E)

    • The nine-month period to develop the initial drug list.
    • Focus on drugs most likely to lower costs, increase competition, address shortages, and improve public health.
    • Priority to chronic/high-cost conditions and drugs available by mail order.
    • Consultation with multiple state agencies, health-related entities, retirement systems, health plan issuers, hospitals, PBMs, and the State Board of Pharmacy to determine which drugs to include and the multi-year distribution/purchase volumes.
  • Public reporting and governance (G)

    • Annually, beginning September 1 after six months from enactment, the administrator must report to the Governor and General Assembly on the program status, impact on competition, availability, and costs.
    • The first report includes detailed administration/oversight plans and governance options (e.g., private organization charter, public-private partnership, or public board).
    • Future reports must continue to cover required information as new drugs are added to the list.
  • Confidentiality and public records (H)

    • Information regarding manufacturer/distribution costs, pricing, rebates, and related proprietary data is protected from public disclosure (not a public record).

Who and what is affected

  • State agencies: Department of Administrative Services, Department of Health, Department of Development.
  • Health system stakeholders: Hospitals, health plan issuers, pharmacy benefit managers, retirees/state retirement systems, public and private purchasers, patients, and health care providers.
  • Drug manufacturers and distributors: Entities that may participate in partnerships; must be FDA-registered.
  • Public: Ohio residents who purchase or are prescribed generically equivalent drugs; potential beneficiaries include those facing high drug costs or shortages.

Procedural and timeline aspects

  • Establishment timeline: Program to be established within 60 days of the section’s effective date.
  • Initial drug list development: Must develop the initial list within nine months after effective date.
  • Reporting timeline: Annual September 1 reports to Governor and General Assembly, with the first report detailing the plan for administering and governance.
  • Ongoing governance: Future reports will include updates as more drugs are listed and as the program evolves.

Notes

  • The bill emphasizes in-state prioritization for purchasing and distribution if supply is limited.
  • It allows for transparent pricing and limits rebates beyond federal requirements.
  • It protects proprietary cost and pricing information from public disclosure.

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

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