summary
Introduced
06/12/2019
06/12/2019
In Committee
06/12/2019
06/12/2019
Crossed Over
Passed
Dead
12/31/2020
12/31/2020
Introduced Session
116th Congress
Bill Summary
Revises and expands various requirements relating to prescription-drug pricing and affordability. Specifically, the bill expands financial reporting requirements for drug manufacturers and establishes corresponding civil penalties for noncompliance; adds reporting requirements for certain nonprofit patient-assistance programs; requires the Centers for Medicare & Medicaid Services (CMS) to negotiate prices for certain prescription drugs under Medicare; 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 and group health plans; modifies requirements for the importation of prescription drugs; requires drug manufacturers to provide drug rebates for drugs dispensed to certain low-income individuals under the Medicare program; limits the time frame that trade agreements are required to provide market exclusivity for biological products; establishes an innovation incentive fund for new or more effective treatments of bacterial infections; establishes a Center for Clinical Research within the National Institutes of Health; revises certain time frames and conditions related to drug exclusivity; requires the Food and Drug Administration to establish a database of generic drugs; and modifies other provisions related to generic drugs, prescription-drug advertising, disclosure of wholesale acquisition prices, and patent-infringement proceedings.
AI Summary
This bill, the Affordable Medications Act, aims to ensure medications are affordable through several key provisions:
It expands financial reporting requirements for drug manufacturers and establishes civil penalties for noncompliance, adds reporting requirements for certain nonprofit patient-assistance programs, requires the Centers for Medicare & Medicaid Services (CMS) to negotiate prices for certain prescription drugs under Medicare, requires the Centers for Medicare and Medicaid Innovation to test models for negotiating drug prices, establishes reporting requirements and penalties for pharmaceutical companies regarding prescription-drug price spikes, establishes an excise tax on prescription drugs subject to price spikes, lessens prescription-drug cost-sharing requirements under qualified health plans and group health plans, modifies requirements for the importation of prescription drugs, requires drug manufacturers to provide drug rebates for drugs dispensed to certain low-income individuals under the Medicare program, limits the time frame that trade agreements are required to provide market exclusivity for biological products, establishes an innovation incentive fund for new or more effective treatments of bacterial infections, establishes a Center for Clinical Research within the National Institutes of Health, revises certain time frames and conditions related to drug exclusivity, requires the FDA to establish a database of generic drugs, and modifies other provisions related to generic drugs, prescription-drug advertising, disclosure of wholesale acquisition prices, and patent-infringement proceedings.
Committee Categories
Budget and Finance
Sponsors (16)
Tina Smith (D)*,
Tammy Baldwin (D),
Richard Blumenthal (D),
Cory Booker (D),
Sherrod Brown (D),
Dick Durbin (D),
Kirsten Gillibrand (D),
Kamala Harris (D),
Maggie Hassan (D),
Amy Klobuchar (D),
Jeff Merkley (D),
Jack Reed (D),
Bernie Sanders (I),
Tom Udall (D),
Elizabeth Warren (D),
Sheldon Whitehouse (D),
Last Action
Read twice and referred to the Committee on Finance. (on 06/12/2019)
Official Document
bill text
bill summary
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bill summary
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bill summary
| Document Type | Source Location |
|---|---|
| State Bill Page | https://www.congress.gov/bill/116th-congress/senate-bill/1801/all-info |
| BillText | https://www.congress.gov/116/bills/s1801/BILLS-116s1801is.pdf |
| Bill | https://www.congress.gov/116/bills/s1801/BILLS-116s1801is.pdf.pdf |
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