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.
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