Affordable Medications Act

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; it also adds reporting requirements for certain nonprofit patient-assistance programs.

Further, the bill requires the Centers for Medicare & Medicaid Services (CMS) to negotiate prices for certain prescription drugs under Medicare and requires the Centers for Medicare and Medicaid Innovation within the CMS to test specified models for negotiating drug prices. It also establishes reporting requirements, and corresponding civil penalties for noncompliance, for pharmaceutical companies with respect to spikes in prescription drug prices.

The bill 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, and modifies requirements for the importation of prescription drugs.

It also requires drug manufacturers to provide rebates for drugs dispensed to certain low-income individuals under the Medicare program and limits the time frame that trade agreements are required to provide market exclusivity for biological products.

Additionally, the bill (1) requires the Food and Drug Administration to establish a database of generic drugs; (2) modifies other provisions related to generic drugs, prescription drug advertising, disclosure of wholesale acquisition prices, and patent-infringement proceedings; and (3) revises certain time frames and conditions related to drug exclusivity.

Finally, it establishes an innovation incentive fund for new or more effective treatments of bacterial infections and establishes the Center for Clinical Research within the National Institutes of Health.