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Bill > HR1776


US HR1776

Improving Access To Affordable Prescription Drugs Act


summary

Introduced
03/29/2017
In Committee
04/05/2017
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: - Expanding reporting requirements for drug manufacturers and establishing civil penalties for noncompliance, adding reporting requirements for certain patient assistance programs, and requiring government reporting on the impact of such programs. - Requiring the Centers for Medicare & Medicaid Services to negotiate prices for certain Medicare prescription drugs, and establishing reporting and testing of drug price negotiation models. - Imposing an excise tax on prescription drugs subject to price spikes, accelerating the closing of the Medicare Part D coverage gap, and allowing importation of certain drugs from Canada and other countries. - Establishing a prize fund for new and more effective treatments of bacterial infections, creating a Center for Clinical Research within the National Institutes of Health to conduct clinical trials, and modifying provisions related to drug exclusivity. - Preserving access to affordable generics by allowing the Federal Trade Commission to take enforcement action against certain patent settlement agreements, and increasing generic drug competition through additional reporting and contracting requirements. - Disallowing tax deductions for direct-to-consumer advertising of prescription drugs and addressing "product hopping" practices.

Committee Categories

Business and Industry, Health and Social Services

Sponsors (24)

Last Action

Referred to the Subcommittee on Health. (on 04/05/2017)

bill text


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