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Bill > S771

US S771

Improving Access To Affordable Prescription Drugs Act

summary

Introduced
03/29/2017
In Committee
03/29/2017
Crossed Over
Passed
Dead
12/31/2018

Introduced Session

115th Congress

Bill Summary

Improving Access To Affordable Prescription Drugs Act 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.

AI Summary

This bill amends various laws to improve access to affordable prescription drugs. Key provisions include: This bill expands reporting requirements for drug manufacturers and establishes civil penalties for noncompliance. It adds reporting requirements for certain nonprofit patient-assistance programs and requires the Government Accountability Office (GAO) to report on the impact of these programs on drug pricing and expenditures. The bill requires the Centers for Medicare & Medicaid Services (CMS) to negotiate prices for certain prescription drugs under Medicare and the Centers for Medicare and Medicaid Innovation within the CMS to test models for negotiating drug prices. It establishes reporting requirements and an excise tax on drugs subject to price spikes, lessens prescription-drug cost-sharing requirements, modifies provisions related to drug importation and rebates for low-income individuals, establishes a prize fund for new antibiotic treatments, and creates a Center for Clinical Research within the National Institutes of Health. The bill also modifies provisions related to drug exclusivity, allows the Federal Trade Commission to initiate enforcement proceedings against certain patent settlement agreements, requires the FDA to establish a database of generic drugs, and makes other changes related to generic drugs, prescription-drug advertising, and product hopping.

Committee Categories

Budget and Finance

Sponsors (16)

Last Action

Read twice and referred to the Committee on Finance. (on 03/29/2017)
(10 Companion Bills)

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