H.R. 1776

This bill amends provisions of various laws relating to prescription-drug pricing and affordability. Specifically, the bill:

• expands reporting requirements for drug manufacturers and establishes corresponding civil penalties for noncompliance;
• adds reporting requirements for certain nonprofit patient-assistance programs;
• requires the Government Accountability Office (GAO) to report to Congress on the impact of patient-assistance programs on prescription-drug pricing and expenditures;
• requires the Centers for Medicare & Medicaid Services (CMS) to negotiate prices for certain prescription drugs under the Medicare program;
• requires the GAO to report to Congress on such negotiations conducted by the CMS;
• 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, group health plans, and the Medicare program;
• modifies provisions related to the importation of prescription drugs;
• requires drug manufacturers to provide drug rebates for drugs dispensed to certain low-income individuals under the Medicare program;
• establishes a prize fund for new and more effective treatments of bacterial infections;
• establishes a Center for Clinical Research within the National Institutes of Health;
• modifies provisions related to drug exclusivity;
• allows the Federal Trade Commission to initiate enforcement proceedings against parties to an agreement resolving or settling a patent-infringement claim in connection with the sale of a drug product;
• requires the Food and Drug Administration to establish a database of generic drugs; and
• modifies other provisions related to generic drugs, prescription-drug advertising, and product hopping.