HR 4692 United States House · 118th Congress

Increasing Prescription Drug Competition Act

HR 4692, the Increasing Prescription Drug Competition Act, prevents brand-name drug companies from using patents on safety protocols (REMS) to block generic drug competition. It requires that generic drug applications aren’t delayed by patent disputes over REMS elements and limits legal remedies to monetary damages - not injunctions - when patents related to safety requirements are infringed. The bill directly affects generic drug manufacturers seeking market entry and brand-name drug sponsors using REMS patents defensively. It does not change safety requirements for drugs but alters how intellectual property disputes over safety protocols are handled during the generic drug approval process. This policy change aims to streamline access to lower-cost generic alternatives by reducing patent-related delays.
Sub-Topics: Prescription Drugs
Bill status in committee 1 of 4 stages cleared
Introduction
Jul 2023
Committee Review
Floor Vote
President
Introduced Jul 17, 2023 Last action Jul 21, 2023
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Full legislative history

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Total actions
3
Key actions
0
Committee
2
Jul 21, 2023
Committee
Referred to the Subcommittee on Health.
lower
Jul 17, 2023
Committee
Referred to the House Committee on Energy and Commerce.
lower
Jul 17, 2023
Introduced
Introduced in House
lower
1 primary · 0 co-sponsors

Sponsors

Role
Legislator
Party
State
District
P
Photo of Elissa Slotkin
Elissa Slotkin
DDemocratic
MI
n/a