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Congressional Research Service
Version 00 · Introduced in Senate · Jun 12, 2019
Affordable Medications Act This bill revises and expands various requirements relating to prescription-drug pricing and affordability. Specifically, the bill
expands financial reporting requirements for drug manufacturers and establishes corresponding civil penalties for noncompliance;
adds reporting requirements for certain nonprofit patient-assistance programs;
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requires the Centers for Medicare & Medicaid Services (CMS) to negotiate prices for certain prescription drugs under Medicare;
requires the Centers for Medicare and Medicaid Innovation within the CMS to test specified models for negotiating drug prices;
establishes reporting requirements, and corresponding civil penalties for noncompliance, for pharmaceutical companies with respect to spikes in prescription-drug prices;
establishes an excise tax on prescription drugs subject to price spikes;
lessens prescription-drug cost-sharing requirements under qualified health plans and group health plans;
modifies requirements for the importation of prescription drugs;
requires drug manufacturers to provide drug rebates for drugs dispensed to certain low-income individuals under the Medicare program;
limits the time frame that trade agreements are required to provide market exclusivity for biological products;
establishes an innovation incentive fund for new or more effective treatments of bacterial infections;
establishes a Center for Clinical Research within the National Institutes of Health;
revises certain time frames and conditions related to drug exclusivity;
requires the Food and Drug Administration to establish a database of generic drugs; and
modifies other provisions related to generic drugs, prescription-drug advertising, disclosure of wholesale acquisition prices, and patent-infringement proceedings.
People & committees
Sen. Smith, Tina [D-MN] · D–MN
Legislative record
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Read twice and referred to the Committee on Finance.
Introduced in Senate
Primary sources
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Source last updated: Jan 3, 2025. Consult Congress.gov for the current record.
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