S. 1801

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.