II 

114TH CONGRESS 

1ST SESSION S. 621 

To amend the Federal Food, Drug, and Cosmetic Act to ensure the safety 

and effectiveness of medically important antimicrobials approved for use 

in the prevention and control of animal diseases, in order to minimize 

the development of antibiotic-resistant bacteria. 

IN THE SENATE OF THE UNITED STATES 

MARCH 2, 2015 

Mrs. FEINSTEIN (for herself, Ms. COLLINS, Mrs. GILLIBRAND, and Ms. WARREN) introduced the following bill; which was read twice and referred to 

the Committee on Health, Education, Labor, and Pensions 

A BILL 

To amend the Federal Food, Drug, and Cosmetic Act to 

ensure the safety and effectiveness of medically important antimicrobials approved for use in the prevention 

and control of animal diseases, in order to minimize 

the development of antibiotic-resistant bacteria. 

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. 

4 This Act may be cited as the ‘‘Preventing Antibiotic 

5 Resistance Act of 2015’’. 


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1 SEC. 2. PURPOSE. 

2 The purpose of this Act is to ensure the safety and 

3 effectiveness of medically important antimicrobials ap4 proved for use in the prevention and control of animal dis5 eases, in order to minimize the development of antibiotic6 resistant bacteria. 

7 SEC. 3. EVIDENCE OF SAFETY OF MEDICALLY IMPORTANT 

8 VETERINARY ANTIMICROBIALS. 

9 (a) APPLICATIONS PENDING OR SUBMITTED AFTER

10 ENACTMENT.—Section 512(d)(1) of the Federal Food, 

11 Drug, and Cosmetic Act (21 U.S.C. 360b(d)(1)) is amend12 ed— 

13 (1) in the first sentence— 

14 (A) in subparagraph (H), by striking ‘‘or’’ 

15 at the end; 

16 (B) in subparagraph (I), by inserting ‘‘or’’ 

17 at the end; and 

18 (C) by inserting after subparagraph (I) the 

19 following: 

20 ‘‘(J) with respect to a medically important 

21 antimicrobial (as defined in subsection (q)), the 

22 applicant has failed to demonstrate that a New 

23 Animal Drug Application for an antimicrobial 

24 labeled for disease prevention or control fails to 

25 meet the criteria in subsection (q)(2)(A);’’; and 


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1 (2) in the second sentence, by striking ‘‘(A) 

2 through (I)’’ and inserting ‘‘(A) through (J)’’. 

3 (b) ENSURING JUDICIOUS USE IN ANIMALS OF

4 MEDICALLY IMPORTANT ANTIMICROBIALS.—Section 512 

5 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

6 360b) is amended by adding at the end the following: 

7 ‘‘(q) ENSURING JUDICIOUS USE IN ANIMALS OF

8 MEDICALLY IMPORTANT ANTIMICROBIALS.— 

9 ‘‘(1) APPLICABILITY.—This subsection applies 

10 to medically important antimicrobials approved for 

11 use in a food-producing animal— 

12 ‘‘(A)(i) for which there is in effect an ap13 proval of an application or an exemption under 

14 subsection (b), (i), or (j) of section 505; or 

15 ‘‘(ii) that is otherwise marketed for human 

16 use; 

17 ‘‘(B) for which the Food and Drug Admin18 istration has initiated or completed withdrawal 

19 or modification of an approved label for growth 

20 promotion, feed efficiency, or other production 

21 use or over-the-counter use, in accordance with 

22 the Guidance for Industry entitled, ‘New Ani23 mal Drugs and New Animal Drug Combination 

24 Products, Administered in or on Medicated 

25 Feed or Drinking Water of Food-Producing 


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1 Animals: Recommendations for Drug Sponsors 

2 for Voluntarily Aligning Product Use Condi3 tions with GFI #209’, published in December 

4 2013; and 

5 ‘‘(C) for which the Food and Drug Admin6 istration has approved a label— 

7 ‘‘(i) for disease control or prevention 

8 at the same or similar dosage level as ap9 plicable for the approved production use 

10 described in subparagraph (B); 

11 ‘‘(ii) that does not specify an explicitly 

12 defined duration of therapy; or 

13 ‘‘(iii) specifying a dosage that is not 

14 expected to treat a specific bacterial patho15 gen. 

16 ‘‘(2) REVIEW OF DISEASE PREVENTION AND

17 CONTROL APPROVALS.— 

18 ‘‘(A) IN GENERAL.—Not later than Janu19 ary 1, 2017, the Secretary shall initiate a proc20 ess whereby— 

21 ‘‘(i) not later than January 1, 2018, 

22 a sponsor of an antimicrobial drug de23 scribed in paragraph (1) shall submit to 

24 the Secretary evidence demonstrating that, 

25 with respect to such drug— 


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1 ‘‘(I) there is evidence of effective2 ness in controlling or preventing bac3 terial disease; 

4 ‘‘(II) an approved use is con5 sistent with accepted veterinary prac6 tice; 

7 ‘‘(III) an approved use is linked 

8 to a specific etiologic agent; 

9 ‘‘(IV) an approved use is appro10 priately targeted to animals at risk of 

11 developing a specific bacterial disease; 

12 ‘‘(V) an approved use has an ex13 plicitly defined duration of therapy; 

14 and 

15 ‘‘(VI) there is reasonable cer16 tainty of no harm to human health 

17 due to the development of anti18 microbial resistance; and 

19 ‘‘(ii)(I) if the Secretary determines 

20 that the evidence submitted under clause 

21 (i) is sufficient to demonstrate that the 

22 drug meets the requirements described in 

23 subclauses (I) through (VI) of such clause, 

24 not later than December 31, 2018, the 

25 Secretary shall issue a revised label apVerDate Sep 11 2014 22:00 Mar 10, 2015 Jkt 049200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S621.IS S621

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1 proval for the antimicrobial drug, as nec2 essary; or 

3 ‘‘(II) if the Secretary determines that 

4 the evidence submitted under clause (i) is 

5 insufficient to demonstrate that the drug 

6 meets the requirements described in sub7 clauses (I) through (VI) of such clause, not 

8 later than December 31, 2018, the Sec9 retary shall withdraw approval of any indi10 cation claims described in paragraph 

11 (1)(C) for which the Secretary determines 

12 the evidence is insufficient and, as nec13 essary, issue a revised label approval. 

14 ‘‘(B) WITHDRAWAL OF CLAIMS.—On or 

15 before January 1, 2018, the sponsor of a drug 

16 described in paragraph (1) may request the ap17 proval of the Secretary to remove any label 

18 claim described in paragraph (1)(C), and the 

19 Secretary shall approve any such request and, 

20 as necessary, issue a revised label. The sponsor 

21 shall not be required to submit the evidence re22 quired under subparagraph (A)(i) with respect 

23 to any claim so withdrawn. 

24 ‘‘(3) EXEMPTIONS.—In the case of a drug that 

25 is a medically important antimicrobial for which the 


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1 Secretary grants an exemption under section 505(i), 

2 the withdrawal of indication claims in a food-pro3 ducing animal in accordance with paragraph (2)(B) 

4 shall be effective on the date that is 2 years after 

5 the date on which the Secretary grants the exemp6 tion, unless, not later than 2 years after the date on 

7 which the Secretary grants the exemption, the Sec8 retary provides a written determination of intent to 

9 extend the exemption. 

10 ‘‘(4) DEFINITION.—In this subsection, the term 

11 ‘medically important antimicrobial’ means a drug 

12 that— 

13 ‘‘(A) is intended for use in food-producing 

14 animals; and 

15 ‘‘(B) is composed wholly or partly of— 

16 ‘‘(i) any kind of penicillin, tetracy17 cline, macrolide, lincosamide, streptogram18 in, aminoglycoside, sulfonamide, cephalo19 sporin, or fluoroquinolone; or 

20 ‘‘(ii) a drug from an antimicrobial 

21 class that is listed as ‘highly important’, 

22 ‘critically important’, or ‘important’ by the 

23 World Health Organization in the latest 

24 edition of its publication entitled ‘Critically 


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1 Important Antimicrobials for Human Med2 icine’ (or a successor publication).’’. 

3 SEC. 4. SENSE OF THE SENATE REGARDING VETERINARY 

4 OVERSIGHT OF USE OF MEDICALLY IMPOR5 TANT ANTIMICROBIALS. 

6 (a) IN GENERAL.—It is the sense of the Senate that 

7 a valid veterinarian-client-patient relationship should exist 

8 to ensure that medically important antimicrobials are used 

9 in food-producing animals in a manner that is consistent 

10 with professionally accepted best practices. 

11 (b) VETERINARIAN-CLIENT-PATIENT RELATION12 SHIP.—In this section, the term ‘‘veterinarian-client-pa13 tient relationship’’ means a relationship in which all of the 

14 following criteria are met: 

15 (1) The veterinarian has assumed the responsi16 bility for making medical judgments regarding the 

17 health of the patient and the client has agreed to 

18 follow the veterinarian’s instructions. 

19 (2) The veterinarian has sufficient knowledge of 

20 the patient to initiate at least a general or prelimi21 nary diagnosis of the medical condition of the pa22 tient. This means that the veterinarian is personally 

23 acquainted with the keeping and care of the patient 

24 by virtue of— 


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1 (A) a timely examination of the patient by 

2 the veterinarian; or 

3 (B) medically appropriate and timely visits 

4 by the veterinarian to the premises where the 

5 animal or animals are kept. 

6 (3) The veterinarian is readily available for fol7 low-up evaluation or has arranged for veterinary 

8 emergency coverage and continuing care and treat9 ment. 

10 (4) The veterinarian provides oversight of treat11 ment, compliance, and outcome. 

12 (5) Patient records are maintained. 

Æ 


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