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Main Subject: Health

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.

HR447-116, HR1093-116, HR1506-116, S73-116, S97-116, S378-116, S1785-116, S64-116, HR1478-116, HR8399-116,

Categories

Administrative law and regulatory procedures Canada Civil actions and liability Congressional oversight Department of Health and Human Services Digestive and metabolic diseases Drug safety, medical device, and laboratory regulation Executive agency funding and structure Government information and archives Government studies and investigations Health care costs and insurance Infectious and parasitic diseases Inflation and prices Intellectual property Marketing and advertising Medicaid Medical research Medicare National Institutes of Health (NIH) Drug safety medical device and laboratory regulation Health

Senate Actions

IntroReferral
Jun. 12 2019	Read twice and referred to the Committee on Finance.

Library of Congress Actions

IntroReferral
Jun. 12 2019	Introduced in Senate

Senate bill S1801-116

Affordable Medications Act

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