Generic Animal Drug Advancement Act

Bill: 118-hr-1683
Sponsor: full_name: Rep. Mace, Nancy [R-SC-1]
Introduced: 2023-03-21
Policy area: Health
Latest action: action_date: 2023-03-31
text: Referred to the Subcommittee on Health.

Summaries:
action_date: 2023-03-21
action_desc: Introduced in House
text: <p><b>Generic Animal Drug Advancement Act</b></p> <p>This bill allows for the approval and corresponding labeling of generic animal drugs that are bioequivalent to another approved drug with respect to at least one species, rather than with respect to all of the same species. (Animal drugs are drugs that are intended for animals other than humans (e.g., pets and livestock). Animal drugs must be approved by the Food and Drug Administration before they may be offered on the commercial market.)</p>

tv_txt: I 118th CONGRESS 1st Session H. R. 1683 IN THE HOUSE OF REPRESENTATIVES March 21, 2023 Ms. Mace introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL To amend the Federal Food, Drug, and Cosmetic Act to make certain changes with respect to the approval of abbreviated applications for the approval of new animal drugs, and for other purposes.

1. Short title This Act may be cited as the Generic Animal Drug Advancement Act . 2. Changes to process for approval of abbreviated applications for the approval of new animal drugs Section 512 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360b ) is amended— (1) in subsection (d)(4), in the matter preceding subparagraph (A), by striking section 512(b)(1) and inserting paragraph (1) or (2) of subsection (b) ; (2) in subsection (n)(1)(F)— (A) by striking or because the new animal drug and inserting because the new animal drug ; and (B) by striking manufacturers; and inserting manufacturers, or because the new animal drug is not shown to be bioequivalent to all of the species for which the approved new animal drug is approved for use; ; and (3) by amending subsection (o) to read as follows: (o) For purposes of this section— (1) the term bioequivalent means, in establishing whether a new animal drug is bioequivalent to an approved new animal drug— (A) demonstrating bioequivalence in at least one major species for which the approved new animal drug is approved for use; or (B) in the case that an approved new animal drug is not approved for use in any major species, demonstrating bioequivalence in at least one species for which the approved new animal drug is approved for use; and (2) the term patent means a patent issued by the United States Patent and Trademark Office; .