[Congressional Bills 104th Congress]
[From the U.S. Government Publishing Office]
[S. 773 Introduced in Senate (IS)]







104th CONGRESS
  1st Session
                                 S. 773

   To amend the Federal Food, Drug, and Cosmetic Act to provide for 
 improvements in the process of approving and using animal drugs, and 
                          for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                  May 9 (legislative day, May 1), 1995

  Mrs. Kassebaum (for herself, Mr. Gregg, Mr. Gorton, Mr. Coats, Mr. 
Jeffords, Mr. Frist, Mr. Harkin, Mr. Craig, Mr. Lugar, Mr. Inhofe, Mr. 
 Grassley, Mr. McConnell, Mr. Kyl, Mr. Santorum, Mr. Heflin, Mr. Bond, 
   Mr. Pryor, Mr. Kerrey, Mr. Bennett, and Mr. Helms) introduced the 
 following bill; which was read twice and referred to the Committee on 
                       Labor and Human Resources

_______________________________________________________________________

                                 A BILL


 
   To amend the Federal Food, Drug, and Cosmetic Act to provide for 
 improvements in the process of approving and using 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; REFERENCE.

    (a) Short Title.--This Act may be cited as the ``Animal Drug 
Availability Act of 1995''.
    (b) Reference.--Whenever in this Act an amendment or repeal is 
expressed in terms of an amendment to, or repeal of, a section or other 
provision, the reference shall be considered to be made to a section or 
other provision of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
321 et seq.).

SEC. 2. FINDINGS.

    Congress finds that--
            (1) the new animal drug approval process has been 
        proceeding too slowly, with the result that necessary and 
        useful drug therapies are being kept from the marketplace;
            (2) the lack of drug approvals for new animal drugs places 
        the health and well-being of animals at risk;
            (3) the expense and delays caused by effectiveness testing 
        for new animal drugs have begun to outweigh the benefits of 
        such testing;
            (4) the overreliance on field investigations to establish 
        the effectiveness of new animal drugs is a primary reason the 
        new animal drug approval process has become so burdensome;
            (5) there are not sufficient approved animal drugs 
        available to treat every specific disease or condition found in 
        each species of animal;
            (6) it would benefit the public health and safety to have 
        many additional animal drugs reviewed and approved by the Food 
        and Drug Administration;
            (7) economic and regulatory incentives are necessary to 
        encourage manufacturers of animal drugs to convert unlabeled 
        uses of the drugs to approved, labeled uses; and
            (8) it is important that the Center for Veterinary Medicine 
        of the Food and Drug Administration promptly implement the 
        recently developed mission, vision, and guiding principles of 
        the Center so that the Food and Drug Administration is a global 
        leader as a public health organization that enables the 
        marketing of safe and effective products.

SEC. 3. EVIDENCE OF EFFECTIVENESS.

    (a) Original Applications.--Section 512(d) (21 U.S.C. 360b(d)) is 
amended by striking paragraph (3) and adding at the end the following 
new paragraph:
    ``(4)(A) As used in this subsection and subsections (c)(2)(F)(iii) 
and (e)(1)(C), the term `substantial evidence' means evidence from 1 or 
more scientifically sound studies, including as appropriate in vitro 
studies, studies in laboratory animals (including a target species), 
bioequivalence studies, tissue residue studies, and any studies 
voluntarily undertaken by or for the applicant, that taken together 
provide reasonable assurance that the drug will have the claimed or 
intended effect of the drug.
    ``(B) For purposes of subparagraph (A), a study shall be considered 
to be scientifically sound if the study is designed and conducted in a 
manner that is consistent with generally recognized scientific 
procedures and principles.''.
    (b) Supplemental Applications.--Section 512(c)(2)(F)(iii) (21 
U.S.C. 360b(c)(2)(F)(iii)) is amended--
            (1) by striking ``reports of new clinical or field 
        investigations (other than bioequivalence or residue studies) 
        and'' and inserting ``substantial evidence (as defined in 
        subsection (d)(4)) of the effectiveness of the drug involved, 
        any studies of animal safety, or''; and
            (2) by striking ``essential to'' and inserting ``, required 
        for''.
    (c) Minor Species and Uses.--Section 512(d)(1) (21 U.S.C. 
360b(d)(1)) is amended by adding at the end the following new sentence: 
``Subparagraph (E) shall not apply to a claim for use of the drug 
described in subparagraph (E) in a minor species, or for a minor use of 
the drug, as the terms `minor species' and `minor use' are defined in 
regulations issued by the Secretary, if there is an application filed 
under subsection (b) for the drug, and the application is approved, 
prior to the submission of the claim.''.
    (d) Combination Drugs.--Section 512(d) (21 U.S.C. 360b(d)) is 
amended by inserting before paragraph (4) (as added by subsection (a)) 
the following new paragraph:
    ``(3) In a case in which a new animal drug contains more than 1 
active ingredient, or the labeling of the drug prescribes, recommends, 
or suggests use of the drug in combination with another animal drug, in 
evaluating the safety and effectiveness of the ingredients or the 
combination, respectively, the Secretary shall consider--
            ``(A) whether any of the active ingredients or any of the 
        drugs in the combination, respectively, alters the safe 
        concentration of another of the active ingredients or drugs in 
        the combination, respectively, or interferes with the methods 
        of analysis for another of the active ingredients or drugs in 
        the combination, respectively;
            ``(B) whether each of the active ingredients or drugs in 
        the combination, respectively, that is claimed to have the same 
        intended effect has been shown to contribute to the effect; and
            ``(C) to the extent that subparagraph (B) does not apply, 
        whether each of the active ingredients or drugs in the 
        combination has an identified target population for which 
        dosing with the active ingredients or combination represents 
        appropriate concurrent therapy.''.
    (e) Withdrawal of Approval.--Section 512(e)(1)(C) (21 U.S.C. 
360b(e)(1)(C)) is amended by inserting after ``substantial evidence'' 
the following: ``(as defined in subsection (d)(4))''.
    (f) Implementation.--
            (1) In general.--Not later than 6 months after the date of 
        enactment of this Act, the Secretary shall issue proposed 
        regulations implementing the amendments made by this section. 
        Not later than 18 months after the date of enactment of this 
        Act, the Secretary shall issue final regulations implementing 
        the amendments.
            (2) Contents.--In issuing regulations implementing the 
        amendments made by this section, and in taking an action to 
        review an application for approval of a new animal drug under 
        section 512 of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 360b), or a request for an investigational exemption for 
        a new animal drug under subsection (j) of such section, that is 
        pending or has been submitted prior to the effective date of 
        the regulations, the Secretary shall--
                    (A) further define the term ``substantial 
                evidence'', as defined in subsection (d)(4) of such 
                section, in a manner that encourages the submission of 
                applications for production drugs that conserve food 
                resources, of applications for veterinary prescription 
                drugs whose use is designed to rely on the experience 
                and training of practitioners in establishing effective 
                doses for such drugs, and of supplemental applications, 
                including applications seeking approval for uses of 
                animal drugs in minor species, for minor uses of such 
                drugs, and for permitted unlabeled uses of such drugs;
                    (B) take into account the proposals contained in 
                the citizen petition (FDA Docket No. 91P-0434/CP) 
                jointly submitted by the American Veterinary Medical 
                Association and the Animal Health Institute, dated 
                October 21, 1991;
                    (C)(i) provide for a conference prior to the 
                submission of an application for approval of a new 
                animal drug under such section, and prior to the 
                submission of a request for an investigational 
                exemption under subsection (j) of such section, to make 
                a decision establishing a submission or an 
                investigational requirement (which decision shall bind 
                the Secretary and the applicant or requester unless the 
                Secretary by order determines that a documented 
                scientific requirement essential to the determination 
                of safety or effectiveness of the animal drug involved 
                has appeared after the conference); and
                    (ii) not later than 10 days after each such 
                conference, by written order, provide a scientific 
                justification specific to the animal drug and intended 
                uses under consideration for requiring studies of types 
                other than the types of studies specified in subsection 
                (d)(4) of such section, as being essential to provide 
                substantial evidence of effectiveness for the intended 
                uses of the drug;
                    (D) define the kinds of evidence that an applicant 
                may use to establish the contribution of each active 
                ingredient in a new animal drug, or new animal drug 
                used in combination with another animal drug, for the 
                same intended effect, as described in subsection 
                (d)(3)(B) of such section; and
                    (E) define the kinds of evidence that an applicant 
                may use to establish the appropriateness of concurrent 
                therapy represented by each active ingredient in a new 
                animal drug, or new animal drug used in combination 
                with another animal drug, for the same intended effect, 
                as described in subsection (d)(3)(C) of such section.
    (g) Report to Congress.--The Secretary shall study any efficiencies 
in the new animal drug approval process that are caused by the 
amendments made by this Act. Not later than 24 months after the date of 
enactment of this Act, the Secretary shall submit to the appropriate 
committees of Congress a report containing the results of the study.

SEC. 4. TIMEFRAME FOR APPROVAL.

    The first sentence of section 512(c)(1) (21 U.S.C. 360b(c)(1)) is 
amended by striking ``one hundred and eighty'' and inserting ``90''.

SEC. 5. DISPUTE RESOLUTION.

    Section 512(c)(1) (21 U.S.C. 360b(c)(1)) is amended--
            (1) in the first sentence--
                    (A) by redesignating subparagraphs (A) and (B) as 
                clauses (i) and (ii), respectively; and
                    (B) by inserting ``(A)'' after ``(1)'';
            (2) in the second sentence, by striking ``If'' and 
        inserting the following:
    ``(C) If''; and
            (3) by inserting after subparagraph (A) (as designated by 
        paragraph (1)(B)) the following new subparagraph:
    ``(B)(i) At any time prior to the issuance of the notice under 
subparagraph (A)(ii), the applicant may, in writing, notify the 
Secretary that an impasse exists in the review of the application with 
respect to a specifically identified issue that is preventing the 
issuance of an order under subparagraph (A)(i).
    ``(ii) On receipt of the notification from the applicant, the 
Secretary shall refer the disputed issue--
            ``(I) to an existing (as of the date of the notification) 
        advisory committee having expertise related to the issue;
            ``(II) to an advisory committee convened in accordance with 
        the procedure in section 721(b)(5)(D); or
            ``(III) to a special Government employee, as defined in 
        section 202(a) of title 18, United States Code, who is 
        acceptable to the Secretary and the applicant.
    ``(iii) The applicant and representatives of the Secretary may 
consult with the committee or employee on the matter referred. The 
committee or employee shall submit to the Secretary and the applicant a 
report containing recommendations (including a statement of reasons for 
the recommendations) regarding the matter not later than 60 days after 
the date of the referral, or not later than 90 days after the date of 
the referral if the committee or employee considers the additional 30 
days to be necessary. Not later than 30 days after the date of 
receiving the report, the Secretary shall, in writing, confirm or 
modify the recommendations received, providing reasons and reference to 
data before the committee or employee for any modification.''.

SEC. 6. LIMITATION ON RESIDUES.

    Section 512(d)(1)(F) (21 U.S.C. 360b(d)(1)(F)) is amended to read 
as follows:
            ``(F) on the basis of information submitted to the 
        Secretary as part of the application or any other information 
        before the Secretary with respect to such drug, any use 
        prescribed, recommended, or suggested in labeling proposed for 
        such drug will result in a residue of such drug in excess of a 
        tolerance found by the Secretary to be safe for such drug;''.

SEC. 7. EXPORT OF NEW ANIMAL DRUGS.

    (a) Export in Accordance With Foreign Law.--Section 801(e)(1) (21 
U.S.C. 381(e)(1)) is amended by striking the last sentence.
    (b) Exports of Certain Unapproved Products.--Section 802 (21 U.S.C. 
382) is amended--
            (1) in subsection (a)(1)(A), by striking ``or section 
        512'';
            (2) in subsection (b)(1)--
                    (A) in subparagraph (A)--
                            (i) by striking the comma at the end of 
                        clause (ii) and inserting ``, or'';
                            (ii) by striking ``or'' at the end of 
                        clause (iii); and
                            (iii) by striking clause (iv); and
                    (B) in subparagraph (C)--
                            (i) by striking ``or 512,'' and inserting a 
                        comma; and
                            (ii) by striking ``or 512(d) or'' and 
                        inserting ``of this Act or section'';
            (3) in subsection (c)(1)(C), by striking ``505 or 512,'' 
        and inserting ``505,''; and
            (4) in subsection (d)--
                    (A) in paragraph (3), by striking ``505 or 512,'' 
                and inserting ``505,''; and
                    (B) in paragraph (4)--
                            (i) by striking ``or 512(j)''; and
                            (ii) by striking ``505 or 512,'' and 
                        inserting ``505,''.
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