Federal

Generic Animal Drug Advancement Act

Source: Congress.gov · 485 words in original text

What This Bill Does

This bill changes how the government approves generic copies of animal drugs. It modifies the Federal Food, Drug, and Cosmetic Act to update the rules for abbreviated applications, which are faster approval processes for animal drugs that copy already-approved medications.

Who It Affects

Companies that make generic animal drugs, companies that make brand-name animal drugs, and the Food and Drug Administration (the federal agency that approves drugs).

Key Provisions

• Companies seeking approval for generic animal drugs must now show their drug works the same way as the original drug in at least one major animal species where the original drug is approved, or if no major species exists, in at least one species where it is approved (Sec. 2(3)(1)(A) and (B)). • The bill adds a new reason to reject a generic animal drug application: when the new drug is not shown to work the same way as the approved drug across all the animal species for which the original drug is approved (Sec. 2(2)(B)). • The bill defines "bioequivalent" (meaning a drug works the same way as another drug) and "patent" (meaning a protection issued by the United States Patent and Trademark Office) for purposes of animal drug approval (Sec. 2(3)).

What Changes

The approval process for generic animal drugs becomes stricter. Companies must now test their drugs in specific animal species to prove they work the same as the original drug, rather than potentially testing in fewer species than currently required.

Important Definitions

Bioequivalent: A drug that demonstrates it works the same way as an already-approved drug in at least one major animal species (or one species if no major species applies). Patent: A protection issued by the United States Patent and Trademark Office.

I 118TH CONGRESS 1ST SESSION H. R. 1683 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. 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. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Generic Animal Drug 4 Advancement Act’’. 5 VerDate Sep 11 2014 01:48 Apr 04, 2023 Jkt 039200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H1683.IH H1683 kjohnson on DSK79L0C42PROD with BILLS 2 •HR 1683 IH SEC. 2. CHANGES TO PROCESS FOR APPROVAL OF ABBRE- 1 VIATED APPLICATIONS FOR THE APPROVAL 2 OF NEW ANIMAL DRUGS. 3 Section 512 of the Federal Food, Drug, and Cosmetic 4 Act (21 U.S.C. 360b) is amended— 5 (1) in subsection (d)(4), in the matter pre- 6 ceding subparagraph (A), by striking ‘‘section 7 512(b)(1)’’ and inserting ‘‘paragraph (1) or (2) of 8 subsection (b)’’; 9 (2) in subsection (n)(1)(F)— 10 (A) by striking ‘‘or because the new animal 11 drug’’ and inserting ‘‘because the new animal 12 drug’’; and 13 (B) by striking ‘‘manufacturers;’’ and in- 14 serting ‘‘manufacturers, or because the new 15 animal drug is not shown to be bioequivalent to 16 all of the species for which the approved new 17 animal drug is approved for use;’’; and 18 (3) by amending subsection (o) to read as fol- 19 lows: 20 ‘‘(o) For purposes of this section— 21 ‘‘(1) the term ‘bioequivalent’ means, in estab- 22 lishing whether a new animal drug is bioequivalent 23 to an approved new animal drug— 24 VerDate Sep 11 2014 01:48 Apr 04, 2023 Jkt 039200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H1683.IH H1683 kjohnson on DSK79L0C42PROD with BILLS 3 •HR 1683 IH ‘‘(A) demonstrating bioequivalence in at 1 least one major species for which the approved 2 new animal drug is approved for use; or 3 ‘‘(B) in the case that an approved new ani- 4 mal drug is not approved for use in any major 5 species, demonstrating bioequivalence in at least 6 one species for which the approved new animal 7 drug is approved for use; and 8 ‘‘(2) the term ‘patent’ means a patent issued by 9 the United States Patent and Trademark Office;’’. 10 Æ VerDate Sep 11 2014 01:48 Apr 04, 2023 Jkt 039200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6301 E:\BILLS\H1683.IH H1683 kjohnson on DSK79L0C42PROD with BILLS

Important: This plain English summary was generated by AI and is provided for informational purposes only. It is not legal advice. Always consult the official bill text on Congress.gov or a qualified attorney for legal matters.