II 

115TH CONGRESS 

1ST SESSION S. 629 

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, control, and treatment of animal diseases, in order 

to minimize the development of antibiotic-resistant bacteria. 

IN THE SENATE OF THE UNITED STATES 

MARCH 14, 2017 

Mrs. FEINSTEIN (for herself and Ms. COLLINS) 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, 

control, and treatment 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 2017’’. 


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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, control, and treatment 

5 of animal diseases, in order to minimize the development 

6 of antibiotic-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 (r)), the 

22 applicant has failed to demonstrate that a new 

23 animal drug application for an antimicrobial la24 beled for disease prevention or control meets 

25 the criteria in subsection (r)(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 ‘‘(r) 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 Guidance for Industry 

18 entitled, ‘New Animal Drugs and New Animal 

19 Drug Combination Products, Administered in 

20 or on Medicated Feed or Drinking Water of 

21 Food-Producing Animals: Recommendations for 

22 Drug Sponsors for Voluntarily Aligning Prod23 uct Use Conditions with GFI #209’, published 

24 in December 2013 applies; and 


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1 ‘‘(C) for which the Food and Drug Admin2 istration has approved a label— 

3 ‘‘(i) for disease control or prevention 

4 at the same or similar dosage level as ap5 plicable for the approved production use 

6 described in subparagraph (B); 

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

8 defined duration of therapy; or 

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

10 expected to treat a specific bacterial patho11 gen. 

12 ‘‘(2) REVIEW OF DISEASE PREVENTION AND

13 CONTROL APPROVALS.— 

14 ‘‘(A) IN GENERAL.—Not later than Janu15 ary 1, 2019, the Secretary shall initiate a proc16 ess of reviewing medically important 

17 antimicrobials described in paragraph (1), in 

18 accordance with subparagraph (B). 

19 ‘‘(B) REVIEW OF APPROVAL.— 

20 ‘‘(i) IN GENERAL.—If, not later than 

21 January 1, 2020, a sponsor of an anti22 microbial drug described in paragraph (1) 

23 submits to the Secretary sufficient evi24 dence to demonstrating that, with respect 

25 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 targets a 

8 specific bacterial pathogen; 

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 not a reasonable 

16 probability of risk to the public health 

17 due to the development of anti18 microbial resistance, 

19 the Secretary, not later than December 31, 

20 2020, shall issue a revised label approval 

21 for such antimicrobial drug, as necessary. 

22 ‘‘(ii) INSUFFICIENT EVIDENCE.—If 

23 the sponsor of an antimicrobial drug de24 scribed in paragraph (1) does not submit 

25 sufficient evidence as described in clause 


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1 (i) by December 31, 2020, the Secretary 

2 shall withdraw approval of any indication 

3 claims described in paragraph (1)(B) for 

4 which the sponsor does not submit evi5 dence or for which the Secretary deter6 mines the evidence submitted is insuffi7 cient and, as necessary, issue a revised 

8 label approval. 

9 ‘‘(C) WITHDRAWAL OF CLAIMS.—On or be10 fore January 1, 2020, the sponsor of a drug de11 scribed in paragraph (1) may request the ap12 proval of the Secretary to remove any label 

13 claim described in paragraph (1)(B), and the 

14 Secretary shall approve any such request and, 

15 as necessary, issue a revised label. The sponsor 

16 shall not be required to submit the evidence re17 quired under subparagraph (B)(i) with respect 

18 to any claim so withdrawn. 

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

20 is a medically important antimicrobial for which the 

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

22 the withdrawal of indication claims in a food-pro23 ducing animal in accordance with paragraph (2)(B) 

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

25 the date on which the Secretary grants the exempVerDate Sep 11 2014 00:10 Mar 18, 2017 Jkt 069200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S629.IS S629

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1 tion, unless, not later than 2 years after the date on 

2 which the Secretary grants the exemption, the Sec3 retary provides a written determination of intent to 

4 extend the exemption. 

5 ‘‘(4) DEFINITION.— 

6 ‘‘(A) IN GENERAL.—In this subsection, the 

7 term ‘medically important antimicrobial’ means 

8 a drug that— 

9 ‘‘(i) is intended for use in food-pro10 ducing animals; and 

11 ‘‘(ii) is composed wholly or partly of— 

12 ‘‘(I) any kind of penicillin, tetra13 cycline, macrolide, lincosamide, 

14 streptogramin, aminoglycoside, sul15 fonamide, cephalosporin, or 

16 fluoroquinolone, or any drug included 

17 in the list pursuant to updates under 

18 subparagraph (B); or 

19 ‘‘(II) a drug from an anti20 microbial class that is listed as ‘highly 

21 important’, ‘critically important’, or 

22 ‘important’ in Appendix A of the 

23 Guidance for Industry entitled, ‘Eval24 uating the Safety of Antimicrobial 

25 New Animal Drugs with Regard to 


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1 Their Microbiological Effects on Bac2 teria of Human Health Concern’ (or 

3 any successor guidance). 

4 ‘‘(B) REVIEW AND UPDATES.—The Sec5 retary shall conduct periodic reviews of the 

6 drugs included in the list described in subpara7 graph (A)(ii)(I), and add to or remove from 

8 such list any drugs that the Secretary deter9 mines appropriate. A review shall be under10 taken at the Secretary’s discretion, but not less 

11 than once every five years.’’. 

12 SEC. 4. VETERINARY OVERSIGHT OF USE OF MEDICALLY 

13 IMPORTANT ANTIMICROBIALS. 

14 (a) IN GENERAL.—A valid veterinarian-client-patient 

15 relationship should exist to ensure that medically impor16 tant antimicrobials are used in food-producing animals in 

17 a manner that is consistent with professionally accepted 

18 best practices. 

19 (b) VETERINARIAN-CLIENT-PATIENT RELATION20 SHIP.—In this section, the term ‘‘veterinarian-client-pa21 tient relationship’’ means a relationship in which all of the 

22 following criteria are met: 

23 (1) The veterinarian has assumed the responsi24 bility for making medical judgments regarding the 


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1 health of the patient and the client has agreed to 

2 follow the veterinarian’s instructions. 

3 (2) The veterinarian has sufficient knowledge of 

4 the patient to initiate at least a general or prelimi5 nary diagnosis of the medical condition of the pa6 tient. This means that the veterinarian is personally 

7 acquainted with the keeping and care of the patient 

8 by virtue of— 

9 (A) a timely examination of the patient by 

10 the veterinarian; or 

11 (B) medically appropriate and timely visits 

12 by the veterinarian to the premises where the 

13 animal or animals are kept. 

14 (3) The veterinarian is readily available for fol15 low-up evaluation or has arranged for veterinary 

16 emergency coverage and continuing care and treat17 ment. 

18 (4) The veterinarian provides oversight of treat19 ment, compliance, and outcome. 

20 (5) Patient records are maintained. 

Æ 


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