118th Congress Health
H.R. 6275: Protecting Consumer Access to Generic Drugs Act of 2023
Introduced
- Introduced (completed)
- Passed House (not reached)
- Passed Senate (not reached)
- To the President (not reached)
- Became law (not reached)
Summary
This bill prohibits the manufacturer of a brand-name, generic, or biosimilar drug from entering into certain agreements to resolve or settle a patent infringement claim in connection with the sale of a drug or biological product.
Specifically, such an agreement shall, with some exceptions, be a violation of the bill if the filer of a subsequent application to market a drug or biological product receives anything of value and agrees to limit or forego research, development, manufacturing, marketing, or sales of the subsequent drug or biological product. (Typically, a subsequent application seeks to market a generic or biosimilar version of a patented drug or biological product.)
Penalties for violations of the bill include civil penalties and loss of the 180-day exclusivity period for a generic drug. The Federal Trade Commission (FTC) shall have exclusive authority to litigate to enforce the bill.
Read the full summary
When a generic or biosimilar drug manufacturer enters into an agreement with another drug manufacturer related to the manufacturing, marketing or sale of a drug, the manufacturers shall certify that the material they have given the FTC concerning the agreement contains (1) the complete agreement; and (2) any agreements related to the main agreement, including descriptions of any oral agreements or representations.
Written by the Congressional Research Service, Library of Congress.
Roll calls
No roll call votes have been held on this bill.
Amendments
No amendments were offered to this bill.
Cosponsors
- Gerald Connolly D-VAOriginal
- Sean Casten D-ILOriginal
- Seth Magaziner D-RI
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Other bills by Marie Gluesenkamp Perez
History
- Introduced in the House by Marie Gluesenkamp Perez.
Show the full action history (3 actions)
- Referred to the Subcommittee on Innovation, Data, and Commerce.
- Introduced in House
- Referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.