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.
Actions
Mar 29, 2017
Read twice and referred to the Committee on Finance.