Summary: S.1801 — 116th Congress (2019-2020)All Information (Except Text)

There is one summary for S.1801. Bill summaries are authored by CRS.

Shown Here:
Introduced in Senate (06/12/2019)

Affordable Medications Act

This bill 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.