I

104TH CONGRESS

1ST SESSION H. R. 2508

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 HOUSE OF REPRESENTATIVES

OCTOBER 19, 1995

Mr. ALLARD (for himself, Mr. KLUG, Mr. STENHOLM, Mr. DINGELL, Mr.

GANSKE, Mr. BARRETT of Nebraska, Mr. BEREUTER, Mr. BOEHNER,

Mr. BROWN of California, Mr. BRYANT of Texas, Mr. BURTON of Indiana, Mr. BUYER, Mr. CHAMBLISS, Mrs. CHENOWETH, Mr. COBLE, Mr.

COMBEST, Mr. CONDIT, Mr. COOLEY, Mr. COSTELLO, Mr. CRAPO, Mrs.

CUBIN, Mr. DE LA GARZA, Mr. DOOLEY, Mr. EHLERS, Mr. EMERSON,

Mr. ENSIGN, Mr. EWING, Mr. GOODLATTE, Mr. GORDON, Mr. GUNDERSON, Mr. HAMILTON, Mr. HEFLEY, Mr. HOLDEN, Mr. HOSTETTLER, Mr.

JOHNSON of South Dakota, Mr. KLECZKA, Mr. LAHOOD, Mrs. LINCOLN,

Mr. LARGENT, Mr. LATHAM, Mr. LEACH, Mr. LEWIS of Kentucky, Mr.

LIGHTFOOT, Mr. LUCAS, Mr. MCINNIS, Mr. MCINTOSH, Ms. MCKINNEY,

Mr. MILLER of Florida, Mr. MINGE, Ms. MOLINARI, Mr. MYERS of Indiana, Mr. NORWOOD, Mr. PASTOR, Mr. PAXON, Mr. PETERSON of Minnesota, Mr. POMBO, Mr. POMEROY, Mr. POSHARD, Mr. ROBERTS, Mr.

ROEMER, Mr. ROSE, Mr. SCHAEFER, Mr. SKEEN, Mr. SOUDER, Mr.

STUMP, Mr. TAYLOR of North Carolina, Mr. THORNBERRY, Mr. THORNTON, Mrs. THURMAN, Mr. WALSH, Mr. WATTS of Oklahoma, and Mr.

WHITFIELD) introduced the following bill; which was referred to the Committee on Commerce

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.
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1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,

3 SECTION 1. SHORT TITLE; REFERENCE.

4 (a) SHORT TITLE.—This Act may be cited as the

5 ‘‘Animal Drug Availability Act of 1995’’.

6 (b) REFERENCE.—Whenever in this Act an amend7 ment or repeal is expressed in terms of an amendment

8 to, or repeal of, a section or other provision, the reference

9 shall be considered to be made to a section or other provi10 sion of the Federal Food, Drug, and Cosmetic Act (21

11 U.S.C. 321 et seq.).

12 SEC. 2. FINDINGS.

13 Congress finds that—

14 (1) the new animal drug approval process has

15 been proceeding too slowly, with the result that nec16 essary and useful drug therapies are being kept from

17 the marketplace;

18 (2) the lack of drug approvals for new animal

19 drugs places the health and well-being of animals at

20 risk;

21 (3) the expense and delays caused by effective22 ness testing for new animal drugs have begun to

23 outweigh the benefits of such testing;

24 (4) the overreliance on field investigations to es25 tablish the effectiveness of new animal drugs is a
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1 primary reason the new animal drug approval proc2 ess has become so burdensome;

3 (5) there are not sufficient approved animal

4 drugs available to treat every specific disease or con5 dition found in each species of animal;

6 (6) it would benefit the public health and safety

7 to have many additional animal drugs reviewed and

8 approved by the Food and Drug Administration;

9 (7) economic and regulatory incentives are nec10 essary to encourage manufacturers of animal drugs

11 to convert unlabeled uses of the drugs to approved,

12 labeled uses; and

13 (8) it is important that the Center for Veteri14 nary Medicine of the Food and Drug Administration

15 promptly implement the recently developed mission,

16 vision, and guiding principles of the Center so that

17 the Food and Drug Administration is a global leader

18 as a public health organization that enables the mar19 keting of safe and effective products.

20 SEC. 3. EVIDENCE OF EFFECTIVENESS.

21 (a) ORIGINAL APPLICATIONS.—Section 512(d) (21

22 U.S.C. 360b(d)) is amended by striking paragraph (3) and

23 by adding at the end the following:

24 ‘‘(4)(A) As used in this subsection and subsections

25 (c)(2)(F)(iii) and (e)(1)(C), the term ‘substantial evi-
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1 dence’ means evidence from 1 or more scientifically sound

2 studies, including as appropriate in vitro studies, studies

3 in laboratory animals (including a target species),

4 bioequivalence studies, and any studies voluntarily under5 taken by or for the applicant, that taken together provide

6 reasonable assurance that the drug will have the claimed

7 or intended effect of the drug.

8 ‘‘(B) For purposes of subparagraph (A), a study shall

9 be considered to be scientifically sound if the study is de10 signed and conducted in a manner that is consistent with

11 generally recognized scientific procedures and principles.’’.

12 (b) SUPPLEMENTAL APPLICATIONS.—Section

13 512(c)(2)(F)(iii) (21 U.S.C. 360b(c)(2)(F)(iii)) is amend14 ed—

15 (1) by striking ‘‘reports of new clinical or field

16 investigations (other than bioequivalence or residue

17 studies) and’’ and inserting ‘‘substantial evidence (as

18 defined in subsection (d)(4)) of the effectiveness of

19 the drug involved, any studies of animal safety, or’’;

20 and

21 (2) by striking ‘‘essential to’’ and inserting ‘‘,

22 required for’’.

23 (c) MINOR SPECIES AND USES.—Section 512(d)(1)

24 (21 U.S.C. 360b(d)(1)) is amended by adding at the end

25 the following new sentence: ‘‘Subparagraph (E) shall not
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1 apply to a claim for use of the drug described in subpara2 graph (E) in a minor species, or for a minor use of the

3 drug, as the terms ‘minor species’ and ‘minor use’ are de4 fined in regulations issued by the Secretary, if there is

5 an application filed under subsection (b) for the drug, and

6 the application is approved, prior to the submission of the

7 claim.’’.

8 (d) COMBINATION DRUGS.—Section 512(d) (21

9 U.S.C. 360b(d)) is amended by inserting before paragraph

10 (4) (as added by subsection (a)) the following new para11 graph:

12 ‘‘(3) In a case in which a new animal drug contains

13 more than 1 active ingredient, or the labeling of the drug

14 prescribes, recommends, or suggests use of the drug in

15 combination with another animal drug, and the active in16 gredients or drugs in the combination have been sepa17 rately approved for particular uses and species prior to

18 the approval of the application for the same uses and spe19 cies in combination (or, in the absence of such approvals,

20 after evaluating the safety and efficacy of the combination

21 itself), the Secretary may only consider with respect to the

22 combination whether any of the active ingredients or any

23 of the drugs in the combination, respectively, at the long24 est withdrawal time of any of the active ingredients or

25 drugs in the combination, respectively, is above its safe
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1 concentration, i.e. exceeds its established tolerance (as

2 measured by its marker residue), or interferes with the

3 methods of analysis for another of the active ingredients

4 or drugs in the combination, respectively.’’.

5 (e) WITHDRAWAL OF APPROVAL.—Section

6 512(e)(1)(C) (21 U.S.C. 360b(e)(1)(C)) is amended by in7 serting after ‘‘substantial evidence’’ the following: ‘‘(as de8 fined in subsection (d)(4))’’.

9 (f) IMPLEMENTATION.—

10 (1) IN GENERAL.—Not later than 6 months

11 after the date of enactment of this Act, the Sec12 retary shall issue proposed regulations implementing

13 the amendments made by this section. Not later

14 than 18 months after the date of enactment of this

15 Act, the Secretary shall issue final regulations imple16 menting the amendments.

17 (2) CONTENTS.—In issuing regulations imple18 menting the amendments made by this section, and

19 in taking an action to review an application for ap20 proval of a new animal drug under section 512 of

21 the Federal Food, Drug, and Cosmetic Act (21

22 U.S.C. 360b), or a request for an investigational ex23 emption for a new animal drug under subsection (j)

24 of such section, that is pending or has been submit-
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1 ted prior to the effective date of the regulations, the

2 Secretary shall—

3 (A) further define the term ‘‘substantial

4 evidence’’, as defined in subsection (d)(4) of

5 such section, in a manner that encourages the

6 submission of applications for production drugs

7 that conserve food resources, of applications for

8 veterinary prescription drugs whose use is de9 signed to rely on the experience and training of

10 practitioners in establishing effective doses for

11 such drugs, and of supplemental applications,

12 including applications seeking approval for uses

13 of animal drugs in minor species, for minor

14 uses of such drugs, and for permitted unlabeled

15 uses of such drugs;

16 (B) take into account the proposals con17 tained in the citizen petition (FDA Docket No.

18 91P–0434/CP) jointly submitted by the Amer19 ican Veterinary Medical Association and the

20 Animal Health Institute, dated October 21,

21 1991;

22 (C)(i) provide for the opportunity for a

23 conference prior to the submission of an appli24 cation for approval of a new animal drug under

25 such section, and prior to the submission of a
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1 request for an investigational exemption under

2 subsection (j) of such section, to make a deci3 sion establishing a submission or an investiga4 tional requirement (which decision shall bind

5 the Secretary and the applicant or requester

6 unless the Secretary by order determines that a

7 documented scientific requirement essential to

8 the determination of safety or effectiveness of

9 the animal drug involved has appeared after the

10 conference); and

11 (ii) not later than 10 days after each such

12 conference, by written order, provide a scientific

13 justification specific to the animal drug and in14 tended uses under consideration for requiring

15 studies of types other than the types of studies

16 specified in subsection (d)(4) of such section, as

17 being essential to provide substantial evidence

18 of effectiveness for the intended uses of the

19 drug;

20 SEC. 4. TIMEFRAME FOR APPROVAL.

21 The first sentence of section 512(c)(1) (21 U.S.C.

22 360b(c)(1)) is amended by striking ‘‘one hundred and

23 eighty’’ and inserting ‘‘90’’.
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1 SEC. 5. DISPUTE RESOLUTION.

2 Section 512(c)(1) (21 U.S.C. 360b(c)(1)) is

3 amended—

4 (1) in the first sentence—

5 (A) by redesignating subparagraphs (A)

6 and (B) as clauses (i) and (ii), respectively; and

7 (B) by inserting ‘‘(A)’’ after ‘‘(1)’’;

8 (2) in the second sentence, by striking ‘‘If’’ and

9 inserting the following:

10 ‘‘(C) If’’; and

11 (3) by inserting after subparagraph (A) (as des12 ignated by paragraph (1)(B)) the following new sub13 paragraph:

14 ‘‘(B)(i) At any time prior to the issuance of the notice

15 under subparagraph (A)(ii), the applicant may, in writing,

16 notify the Secretary that an impasse exists in the review

17 of the application with respect to a specifically identified

18 issue that is preventing the issuance of an order under

19 subparagraph (A)(i).

20 ‘‘(ii) On receipt of the notification from the applicant,

21 the Secretary shall refer the disputed issue—

22 ‘‘(I) to an existing (as of the date of the notifi23 cation) advisory committee having expertise related

24 to the issue;
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1 ‘‘(II) to an advisory committee convened in ac2 cordance with the procedure in section 721(b)(5)(D);

3 or

4 ‘‘(III) to a special Government employee, as de5 fined in section 202(a) of title 18, United States

6 Code, who is acceptable to the Secretary and the ap7 plicant.

8 ‘‘(iii) The applicant and representatives of the Sec9 retary may consult with the committee or employee on the

10 matter referred. The committee or employee shall submit

11 to the Secretary and the applicant a report containing rec12 ommendations (including a statement of reasons for the

13 recommendations) regarding the matter not later than 60

14 days after the date of the referral, or not later than 90

15 days after the date of the referral if the committee or em16 ployee considers the additional 30 days to be necessary.

17 Not later than 30 days after the date of receiving the re18 port, the Secretary shall, in writing, confirm or modify the

19 recommendations received, providing reasons and ref20 erence to data before the committee or employee for any

21 modification.’’.

22 SEC. 6. LIMITATION ON RESIDUES.

23 Section 512(d)(1)(F) (21 U.S.C. 360b(d)(1)(F)) is

24 amended to read as follows:
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1 ‘‘(F) on the basis of information submitted to

2 the Secretary as part of the application or any other

3 information before the Secretary with respect to

4 such drug, any use prescribed, recommended, or

5 suggested in labeling proposed for such drug will re6 sult in a residue of such drug in excess of a toler7 ance found by the Secretary to be safe for such

8 drug;’’.

9 SEC. 7. EXPORT OF NEW ANIMAL DRUGS.

10 (a) EXPORT IN ACCORDANCE WITH FOREIGN

11 LAW.—Section 801(e)(1) (21 U.S.C. 381(e)(1)) is amend12 ed by striking the last sentence.

13 (b) EXPORTS OF CERTAIN UNAPPROVED PROD14 UCTS.—Section 802 (21 U.S.C. 382) is amended—

15 (1) in subsection (a)(1)(A), by striking ‘‘or sec16 tion 512’’;

17 (2) in subsection (b)(1)—

18 (A) in subparagraph (A)—

19 (i) by striking the comma at the end

20 of clause (ii) and inserting ‘‘, or’’;

21 (ii) by striking ‘‘or’’ at the end of

22 clause (iii); and

23 (iii) by striking clause (iv); and

24 (B) in subparagraph (C)—
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1 (i) by striking ‘‘or 512,’’ and inserting

2 a comma; and

3 (ii) by striking ‘‘or 512(d) or’’ and in4 serting ‘‘of this Act or section’’;

5 (3) in subsection (c)(1)(C), by striking ‘‘505 or

6 512,’’ and inserting ‘‘505,’’; and

7 (4) in subsection (d)—

8 (A) in paragraph (3), by striking ‘‘505 or

9 512,’’ and inserting ‘‘505,’’; and

10 (B) in paragraph (4)—

11 (i) by striking ‘‘or 512(j)’’; and

12 (ii) by striking ‘‘505 or 512,’’ and in13 serting ‘‘505,’’.

14 SEC. 8. REPORT TO CONGRESS.

15 The Secretary shall study any efficiencies in the new

16 animal drug approval process that are caused by the

17 amendments made by this Act. Not later than 24 months

18 after the date of enactment of this Act, the Secretary shall

19 submit to the appropriate committees of Congress a report

20 containing the results of the study.

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