Increasing Prescription Drug Competition Act
This bill prevents brand-name drug companies from using patents related to drug safety programs (REMS) to delay generic drug approvals. It ensures that generic drug makers' certifications about these safety program patents do not delay their applications' approval dates. The bill also limits legal claims against generic makers who use safety program elements, allowing only monetary damages for infringement - not injunctions. It does not change required safety programs or affect antitrust laws. The bill directly affects drug manufacturers seeking approvals under FDA regulations and generic drug applicants.
Bill status
in committee
1 of 4 stages cleared
Introduction
Mar 2023
Committee Review
Floor Vote
President
Introduced Mar 1, 2023
Last action Mar 1, 2023
Floor votes
How they voted
No floor votes recorded yet.
Full legislative history
Actions timeline
Total actions
2
Key actions
0
Committee
1
Mar 1, 2023
Senate · Referred to committee
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Mar 1, 2023
Senate · Introduced
Introduced in Senate
1 primary · 1 co-sponsor
Sponsors
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