Title: Generic Animal Drug Advancement Act
Policy area: Health

Summary:
Generic Animal Drug Advancement Act
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.)

[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 8857 Introduced in House (IH)]

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117th CONGRESS
  2d Session
                                H. R. 8857

   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

                           September 15, 2022

   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 Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Generic Animal Drug Advancement 
Act''.

SEC. 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'';
                    (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;''.
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