{"@context":"https://schema.org","@type":"Legislation","name":"To improve access to affordable prescription drugs.","description":"

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.

","legislationIdentifier":"HR 1776","legislationType":"Bill","legislationLegalForce":"NotInForce","legislationJurisdiction":"USA","author":[{"@type":"Person","name":"Janice D. Schakowsky","url":"https://legisdaily.com/mp/janiced-schakowsky-us"}],"about":{"@type":"Thing","name":"Health"},"keywords":"Administrative law and regulatory procedures, Administrative remedies, Business records, Canada, Cancer, Civil actions and liability, Competition and antitrust, Congressional oversight, Consumer affairs, Corporate finance and management, Department of Health and Human Services, Drug safety, medical device, and laboratory regulation, Drug therapy, Executive agency funding and structure, Federal Trade Commission (FTC), Government information and archives, Government studies and investigations, Government trust funds, Health care costs and insurance, Health care coverage and access, Health programs administration and funding, Income tax deductions, Infectious and parasitic diseases, Inflation and prices, Judicial review and appeals, Licensing and registrations, Marketing and advertising, Medicaid, Medical research, Medicare, National Institutes of Health (NIH), Prescription drugs, Public contracts and procurement, Research and development, Retail and wholesale trades, Trade restrictions, User charges and fees, Veterans' medical care","dateModified":"2025-06-04T00:00:00.000Z","url":"https://legisdaily.com/bill/USA-115-HR-1776"}

Janice D. Schakowsky

Janice D. Schakowsky

Ways and Means Committee, Health Subcommittee, Health Subcommittee, Judiciary Committee, Energy and Commerce Committee