118th Congress · HOUSE BILLBILL

H.R. 6275 — Protecting Consumer Access to Generic Drugs Act of 2023

“To prohibit brand name drug manufacturers from compensating generic drug manufacturers to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable product manufacturers to delay entry of biosimilar and interchangeable products, and for other purposes.”

Health

Introduced Nov 7, 2023

Last action Nov 10, 2023

Pipeline · Bill → Law

Step 1

Introduced

Nov 7, 2023

Step 2

Referred

Nov 10, 2023

E&C · Judiciary

Step 3

Committee

Step 4

House floor

Step 5

Senate

Step 6

Resolve Changes

Step 7

Signed

SummaryCRS 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 f...

Provisions · 6 sectionsIntroduced in House

Timeline · 4 actions

Nov 10, 2023

Referred to the Subcommittee on Innovation, Data, and Commerce.

Nov 7, 2023

Introduced in House

Nov 7, 2023

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.

Nov 7, 2023