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Affordable Medications Act

Introduced: June 12, 2019 Introduced by: Smith, Tina Democratic · Minnesota See on congress.gov

Everywhere this bill has been 2 steps

Introduced

In committee

Reported out

Passed House

Passed Senate

To President

Became law

Jun 12, 2019

Read twice and referred to the Committee on Finance.

Jun 12, 2019

Introduced in Senate

Plain-English summary Congressional Research Service

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.