Title: Preventing Antibiotic Resistance Act of 2017
Policy area: Health

Summary:
Preventing Antibiotic Resistance Act of 2017
This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to refuse a new animal drug application if the drug is a medically important antimicrobial used to treat humans and the applicant fails to demonstrate that the drug meets specified criteria for use in animals, including that: (1) the drug is effective, (2) the drug is targeted to animals at risk of developing a specific bacterial disease, (3) the drug has a defined duration of therapy, and (4) there is not a reasonable probability of risk to public health from microbial resistance to the drug.
The FDA must review the approvals of certain medically important antimicrobials approved for use in food-producing animals. Sponsors of these drugs must submit evidence to the FDA that demonstrates that their drug meets the criteria described above for approved indications. The FDA must withdraw approval for any indication for which there is insufficient evidence that the drug meets the criteria.

[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[S. 629 Introduced in Senate (IS)]

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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.

    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 ``Preventing Antibiotic Resistance Act 
of 2017''.

SEC. 2. PURPOSE.

    The purpose of this Act is 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.

SEC. 3. EVIDENCE OF SAFETY OF MEDICALLY IMPORTANT VETERINARY 
              ANTIMICROBIALS.

    (a) Applications Pending or Submitted After Enactment.--Section 
512(d)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360b(d)(1)) is amended--
            (1) in the first sentence--
                    (A) in subparagraph (H), by striking ``or'' at the 
                end;
                    (B) in subparagraph (I), by inserting ``or'' at the 
                end; and
                    (C) by inserting after subparagraph (I) the 
                following:
                    ``(J) with respect to a medically important 
                antimicrobial (as defined in subsection (r)), the 
                applicant has failed to demonstrate that a new animal 
                drug application for an antimicrobial labeled for 
                disease prevention or control meets the criteria in 
                subsection (r)(2)(A);''; and
            (2) in the second sentence, by striking ``(A) through (I)'' 
        and inserting ``(A) through (J)''.
    (b) Ensuring Judicious Use in Animals of Medically Important 
Antimicrobials.--Section 512 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360b) is amended by adding at the end the following:
    ``(r) Ensuring Judicious Use in Animals of Medically Important 
Antimicrobials.--
            ``(1) Applicability.--This subsection applies to medically 
        important antimicrobials approved for use in a food-producing 
        animal--
                    ``(A)(i) for which there is in effect an approval 
                of an application or an exemption under subsection (b), 
                (i), or (j) of section 505; or
                    ``(ii) that is otherwise marketed for human use;
                    ``(B) for which the Guidance for Industry entitled, 
                `New Animal Drugs and New Animal Drug Combination 
                Products, Administered in or on Medicated Feed or 
                Drinking Water of Food-Producing Animals: 
                Recommendations for Drug Sponsors for Voluntarily 
                Aligning Product Use Conditions with GFI #209', 
                published in December 2013 applies; and
                    ``(C) for which the Food and Drug Administration 
                has approved a label--
                            ``(i) for disease control or prevention at 
                        the same or similar dosage level as applicable 
                        for the approved production use described in 
                        subparagraph (B);
                            ``(ii) that does not specify an explicitly 
                        defined duration of therapy; or
                            ``(iii) specifying a dosage that is not 
                        expected to treat a specific bacterial 
                        pathogen.
            ``(2) Review of disease prevention and control approvals.--
                    ``(A) In general.--Not later than January 1, 2019, 
                the Secretary shall initiate a process of reviewing 
                medically important antimicrobials described in 
                paragraph (1), in accordance with subparagraph (B).
                    ``(B) Review of approval.--
                            ``(i) In general.--If, not later than 
                        January 1, 2020, a sponsor of an antimicrobial 
                        drug described in paragraph (1) submits to the 
                        Secretary sufficient evidence to demonstrating 
                        that, with respect to such drug--
                                    ``(I) there is evidence of 
                                effectiveness in controlling or 
                                preventing bacterial disease;
                                    ``(II) an approved use is 
                                consistent with accepted veterinary 
                                practice;
                                    ``(III) an approved use targets a 
                                specific bacterial pathogen;
                                    ``(IV) an approved use is 
                                appropriately targeted to animals at 
                                risk of developing a specific bacterial 
                                disease;
                                    ``(V) an approved use has an 
                                explicitly defined duration of therapy; 
                                and
                                    ``(VI) there is not a reasonable 
                                probability of risk to the public 
                                health due to the development of 
                                antimicrobial resistance,
                        the Secretary, not later than December 31, 
                        2020, shall issue a revised label approval for 
                        such antimicrobial drug, as necessary.
                            ``(ii) Insufficient evidence.--If the 
                        sponsor of an antimicrobial drug described in 
                        paragraph (1) does not submit sufficient 
                        evidence as described in clause (i) by December 
                        31, 2020, the Secretary shall withdraw approval 
                        of any indication claims described in paragraph 
                        (1)(B) for which the sponsor does not submit 
                        evidence or for which the Secretary determines 
                        the evidence submitted is insufficient and, as 
                        necessary, issue a revised label approval.
                    ``(C) Withdrawal of claims.--On or before January 
                1, 2020, the sponsor of a drug described in paragraph 
                (1) may request the approval of the Secretary to remove 
                any label claim described in paragraph (1)(B), and the 
                Secretary shall approve any such request and, as 
                necessary, issue a revised label. The sponsor shall not 
                be required to submit the evidence required under 
                subparagraph (B)(i) with respect to any claim so 
                withdrawn.
            ``(3) Exemptions.--In the case of a drug that is a 
        medically important antimicrobial for which the Secretary 
        grants an exemption under section 505(i), the withdrawal of 
        indication claims in a food-producing animal in accordance with 
        paragraph (2)(B) shall be effective on the date that is 2 years 
        after the date on which the Secretary grants the exemption, 
        unless, not later than 2 years after the date on which the 
        Secretary grants the exemption, the Secretary provides a 
        written determination of intent to extend the exemption.
            ``(4) Definition.--
                    ``(A) In general.--In this subsection, the term 
                `medically important antimicrobial' means a drug that--
                            ``(i) is intended for use in food-producing 
                        animals; and
                            ``(ii) is composed wholly or partly of--
                                    ``(I) any kind of penicillin, 
                                tetracycline, macrolide, lincosamide, 
                                streptogramin, aminoglycoside, 
                                sulfonamide, cephalosporin, or 
                                fluoroquinolone, or any drug included 
                                in the list pursuant to updates under 
                                subparagraph (B); or
                                    ``(II) a drug from an antimicrobial 
                                class that is listed as `highly 
                                important', `critically important', or 
                                `important' in Appendix A of the 
                                Guidance for Industry entitled, 
                                `Evaluating the Safety of Antimicrobial 
                                New Animal Drugs with Regard to Their 
                                Microbiological Effects on Bacteria of 
                                Human Health Concern' (or any successor 
                                guidance).
                    ``(B) Review and updates.--The Secretary shall 
                conduct periodic reviews of the drugs included in the 
                list described in subparagraph (A)(ii)(I), and add to 
                or remove from such list any drugs that the Secretary 
                determines appropriate. A review shall be undertaken at 
                the Secretary's discretion, but not less than once 
                every five years.''.

SEC. 4. VETERINARY OVERSIGHT OF USE OF MEDICALLY IMPORTANT 
              ANTIMICROBIALS.

    (a) In General.--A valid veterinarian-client-patient relationship 
should exist to ensure that medically important antimicrobials are used 
in food-producing animals in a manner that is consistent with 
professionally accepted best practices.
    (b) Veterinarian-Client-Patient Relationship.--In this section, the 
term ``veterinarian-client-patient relationship'' means a relationship 
in which all of the following criteria are met:
            (1) The veterinarian has assumed the responsibility for 
        making medical judgments regarding the health of the patient 
        and the client has agreed to follow the veterinarian's 
        instructions.
            (2) The veterinarian has sufficient knowledge of the 
        patient to initiate at least a general or preliminary diagnosis 
        of the medical condition of the patient. This means that the 
        veterinarian is personally acquainted with the keeping and care 
        of the patient by virtue of--
                    (A) a timely examination of the patient by the 
                veterinarian; or
                    (B) medically appropriate and timely visits by the 
                veterinarian to the premises where the animal or 
                animals are kept.
            (3) The veterinarian is readily available for follow-up 
        evaluation or has arranged for veterinary emergency coverage 
        and continuing care and treatment.
            (4) The veterinarian provides oversight of treatment, 
        compliance, and outcome.
            (5) Patient records are maintained.
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