HR 1683 United States House · 118th Congress

Generic Animal Drug Advancement Act

HR 1683, the Generic Animal Drug Advancement Act, simplifies the approval process for generic animal drugs by changing bioequivalence requirements. It requires manufacturers to demonstrate that a generic drug is bioequivalent to an approved drug in *at least one major species* (not all species), making it easier to bring generic versions to market. This directly affects animal drug manufacturers seeking to produce lower-cost alternatives to existing approved drugs. The bill clarifies key terms like "bioequivalent" and "patent" within the existing regulatory framework to streamline approvals.
Bill status in committee 1 of 4 stages cleared
Introduction
Mar 2023
Committee Review
Floor Vote
President
Introduced Mar 21, 2023 Last action Mar 31, 2023
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Full legislative history

Actions timeline

Total actions
3
Key actions
0
Committee
2
Mar 31, 2023
Committee
Referred to the Subcommittee on Health.
lower
Mar 21, 2023
Committee
Referred to the House Committee on Energy and Commerce.
lower
Mar 21, 2023
Introduced
Introduced in House
lower
1 primary · 0 co-sponsors

Sponsors

Role
Legislator
Party
State
District
P
Photo of Nancy Mace
Nancy Mace
RRepublican
SC
1