Affordable Medications Act

Summary

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; 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.

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3 official files

• Introduced in Senate (text)

  Introduced in Senate · EN · 12 June 2019

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• Introduced in Senate (PDF)

  Introduced in Senate · EN · 12 June 2019

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• Introduced in Senate

  summary · EN · 12 June 2019

  Open at official source

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