Preventing Antibiotic Resistance Act of 2015

Summary: Preventing Antibiotic Resistance Act of 2015 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 reasonable certainty of no harm to human health from microbial resistance to the drug. Sponsors of certain medically important antimicrobials already approved for use in food-producing animals 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 the FDA determines there is insufficient evidence that the drug meets the criteria. This bill expresses the sense of the Senate that a veterinarian-client-patient relationship should ensure that medically important antimicrobials are used in food-producing animals in a manner consistent with best practices.

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Preventing Antibiotic Resistance Act 
of 2015''.

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 and control 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 (q)), the 
                applicant has failed to demonstrate that a New Animal 
                Drug Application for an antimicrobial labeled for 
                disease prevention or control fails to meet the 
                criteria in subsection (q)(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:
    ``(q) 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 Food and Drug Administration 
                has initiated or completed withdrawal or modification 
                of an approved label for growth promotion, feed 
                efficiency, or other production use or over-the-counter 
                use, in accordance with 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; 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, 2017, 
                the Secretary shall initiate a process whereby--
                            ``(i) not later than January 1, 2018, a 
                        sponsor of an antimicrobial drug described in 
                        paragraph (1) shall submit to the Secretary 
                        evidence 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 is linked 
                                to a specific etiologic agent;
                                    ``(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 reasonable 
                                certainty of no harm to human health 
                                due to the development of antimicrobial 
                                resistance; and
                            ``(ii)(I) if the Secretary determines that 
                        the evidence submitted under clause (i) is 
                        sufficient to demonstrate that the drug meets 
                        the requirements described in subclauses (I) 
                        through (VI) of such clause, not later than 
                        December 31, 2018, the Secretary shall issue a 
                        revised label approval for the antimicrobial 
                        drug, as necessary; or
                            ``(II) if the Secretary determines that the 
                        evidence submitted under clause (i) is 
                        insufficient to demonstrate that the drug meets 
                        the requirements described in subclauses (I) 
                        through (VI) of such clause, not later than 
                        December 31, 2018, the Secretary shall withdraw 
                        approval of any indication claims described in 
                        paragraph (1)(C) for which the Secretary 
                        determines the evidence is insufficient and, as 
                        necessary, issue a revised label approval.
                    ``(B) Withdrawal of claims.--On or before January 
                1, 2018, 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)(C), 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 (A)(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.--In this subsection, the term `medically 
        important antimicrobial' means a drug that--
                    ``(A) is intended for use in food-producing 
                animals; and
                    ``(B) is composed wholly or partly of--
                            ``(i) any kind of penicillin, tetracycline, 
                        macrolide, lincosamide, streptogramin, 
                        aminoglycoside, sulfonamide, cephalosporin, or 
                        fluoroquinolone; or
                            ``(ii) a drug from an antimicrobial class 
                        that is listed as `highly important', 
                        `critically important', or `important' by the 
                        World Health Organization in the latest edition 
                        of its publication entitled `Critically 
                        Important Antimicrobials for Human Medicine' 
                        (or a successor publication).''.

SEC. 4. SENSE OF THE SENATE REGARDING VETERINARY OVERSIGHT OF USE OF 
              MEDICALLY IMPORTANT ANTIMICROBIALS.

    (a) In General.--It is the sense of the Senate that 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.