Preservation of Antibiotics for Medical Treatment Act of 2015

Summary: Preservation of Antibiotics for Medical Treatment Act of 2015 This bill amends the Federal Food, Drug, and Cosmetic Act to require an applicant for approval of a new animal drug that is a medically important antimicrobial to demonstrate that there is a reasonable certainty of no harm to human health from antimicrobial resistance attributable to the nontherapeutic use of the drug. Medically important antimicrobials are drugs intended for use in food-producing animals that contain: (1) specified antibiotics, or (2) certain drugs on the World Health Organization&rsquo;s list of critically important antimicrobials.  Two years after enactment of this Act, the Food and Drug Administration (FDA) must withdraw approval of a drug's nontherapeutic use in food-producing animals unless the FDA makes a determination that, based on the application holder's demonstration or an FDA risk analysis, there is a reasonable certainty of no harm to human health from antimicrobial resistance attributable to nontherapeutic use.  The FDA must rescind an exemption for investigational use of, or approval of a new drug application for, a medically important antimicrobial for its nontherapeutic use in food-producing animals two years after the exemption is granted or the application for approval is submitted unless there is a reasonable certainty of no harm to human health from antimicrobial resistance attributable to nontherapeutic use. A medically important antimicrobial cannot be administered (including through animal feed) to a food-producing animal for disease control unless there is a significant risk that a disease or infection present on the premises will be transmitted to the animal.

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Preservation of Antibiotics for 
Medical Treatment Act of 2015''.

SEC. 2. FINDINGS.

    The Congress finds the following:
            (1) All uses of antibiotics, including for food-producing 
        animals, have the potential to cause resistance and contribute 
        to the development of antibiotic-resistant bacterial infections 
        in people.
            (2) In 1977, the Food and Drug Administration (FDA) 
        concluded that feeding livestock low doses of antibiotics used 
        in human disease treatment could promote the development of 
        antibiotic resistance in bacteria. However, the Food and Drug 
        Administration did not act in response to these findings, 
        despite laws requiring the agency to do so.
            (3) In 2012, the Food and Drug Administration Guidance for 
        Industry #209 provided a summary of over 40 years of peer-
        reviewed scientific literature regarding use of antimicrobial 
        drugs in livestock which reiterated that the use of antibiotics 
        in animals contributes to the resistance in human pathogens and 
        concludes that strategies for controlling antibiotic 
        resistance, including limiting medically important 
        antimicrobial drugs in food-producing animals only to uses that 
        are considered necessary for assuring animal health are needed.
            (4) The 2014 President's Council of Advisors on Science and 
        Technology Report to the President on Combating Antibiotic-
        Resistant Bacteria also concludes that substantial evidence 
        exists that the use of antibiotics in food animals promotes the 
        development and spread of antibiotic resistance in bacteria 
        that can spread to people and that it is clear that 
        agricultural use of antibiotics can affect human health.
            (5) Recently published scientific studies have shown that 
        food-producing animals, and animal production facilities, are a 
        source of antibiotic-resistant bacteria which have infected 
        humans and present an increased risk of acquiring and 
        antibiotics resistant infection.
            (6) Antibiotic resistance is a crisis which threatens 
        public health, the economy, and national security.
            (7) In 2013, the Centers for Disease Control and Prevention 
        estimated that antibiotic-resistant infections cause at least 2 
        million infections, 23,000 deaths, 8 million additional 
        hospital days, and $20 to $35 billion in excess direct health 
        care costs each year in the United States.
            (8) The 2014 World Health Organization report, 
        ``Antimicrobial Resistance: Global Report on Surveillance 
        2014'', concluded that antimicrobial resistance is a current 
        reality and the problem is so serious that it threatens the 
        achievements of modern medicine.
            (9) Without effective antibiotics--
                    (A) common infections could become untreatable--
                even fatal; and
                    (B) medical advances such as joint replacements, 
                Cesarean sections, organ transplants and chemotherapy 
                could become nonviable.
            (10) Antibiotic resistance, resulting in a reduced number 
        of effective antibiotics, may significantly impair the ability 
        of the United States to respond to terrorist attacks involving 
        bacterial infections, such as anthrax and smallpox, or to an 
        event resulting in a large influx of hospitalized patients.
            (11) In 2011, the Food and Drug Administration determined 
        that--
                    (A) 13.5 million kilograms of antibacterial drugs 
                were sold for use on food animals in the United States 
                in 2010;
                    (B) 3.3 million kilograms of antibacterial drugs 
                were used for human health in 2010; and
                    (C) therefore, 80 percent of antibacterial drugs 
                disseminated in the United States in 2010 were sold for 
                use on food animals, rather than being used for human 
                health.
            (12) The ``FDA Annual Summary Report on Antimicrobials Sold 
        or Distributed in 2012 for Use in Food-Producing Animals'' 
        showed that the use of medically important antibiotics in food-
        producing animals increased 16 percent from 2009 to 2012.
            (13)(A) In 2003, the Food and Drug Administration modified 
        the drug approval process for antibiotics to recognize the 
        development of resistant bacteria as an important aspect of 
        safety, but most antibiotics currently used in animal 
        production systems for nontherapeutic purposes were approved 
        before the Food and Drug Administration began considering 
        resistance during the drug-approval process.
            (B) The Food and Drug Administration has not established a 
        schedule for reviewing those existing approvals.
            (14) A stated goal of FDA Guidance documents 209 and 213 is 
        a reduction in the overall consumption of antibiotics. The FDA 
        policy continues to allow the use of antibiotics for routine 
        disease prevention without requiring evidence of the presence 
        of a specific disease or requiring the mitigation of conditions 
        which elevate disease risk.
            (15) There is inadequate distinction between usage for 
        disease prevention and production purposes, such as growth 
        promotion, on FDA approved drug labels. A 2014 analysis of the 
        approved animal drugs affected by Guidance 213 by the Pew 
        Charitable Trusts found that numerous approved drug labels 
        contained overlapping indications for growth-promotion and 
        disease prevention.
            (16) The European Union (EU) banned the use of antibiotics 
        for growth promotion in 2006, a full decade before the FDA's 
        voluntary approach will go into effect.
            (17) Since the EU ban, antibiotic usage has decreased 
        without affecting livestock production.
            (18) In 2010, the Danish Veterinary and Food Administration 
        testified that the Danish ban of the nontherapeutic use of 
        antibiotics in food-animal production resulted in a marked 
        reduction in antimicrobial resistance in multiple bacterial 
        species, including Campylobacter and Enterococci.
            (19) The experience in the Netherlands has shown that 
        during the phaseout use indications for growth promotion were 
        completely supplanted by disease prevention. Total antibiotic 
        consumption remained constant. After the implementation of 
        mandatory reduction targets and improved surveillance of usage 
        practices antibiotic consumption declined ahead of target 
        without impacting production levels.
            (20) In 2009, the Congressional Research Service concluded 
        that without restrictions on the use of antimicrobial drugs in 
        the production of livestock, export markets for livestock and 
        poultry could be negatively impacted due to restrictions on the 
        use of antibiotics in other nations.
            (21) The American Medical Association, the Infectious 
        Disease Society of America, the American Public Health 
        Association, the National Association of County and City Health 
        Officials, and the National Sustainable Agriculture Coalition 
        are among the over 400 organizations representing health, 
        consumer, agricultural, environmental, humane, and other 
        interests that have supported enactment of legislation to 
        phaseout nontherapeutic use in farm animals of medically 
        important antimicrobials.

SEC. 3. PURPOSE.

    The purpose of this Act is to preserve the effectiveness of 
medically important antimicrobials used in the treatment of human and 
animal diseases.

SEC. 4. PROOF OF SAFETY OF MEDICALLY IMPORTANT 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 there is a 
                reasonable certainty of no harm to human health due to 
                the development of antimicrobial resistance that is 
                attributable, in whole or in part, to the 
                nontherapeutic use (as defined in subsection (q)) of 
                the medically important antimicrobial or drug;''; and
            (2) in the second sentence, by striking ``(A) through (I)'' 
        and inserting ``(A) through (J)''.
    (b) Phased Elimination of Nontherapeutic 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) Phased Elimination of Nontherapeutic Use in Animals of 
Medically Important Antimicrobials.--
            ``(1) Applicability.--This paragraph applies to the 
        nontherapeutic use in a food-producing animal of a drug--
                    ``(A) that is a medically important antimicrobial; 
                or
                    ``(B)(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.
            ``(2) Withdrawal.--The Secretary shall withdraw the 
        approval of a nontherapeutic use in food-producing animals of a 
        drug described in paragraph (1) on the date that is 2 years 
        after the date of enactment of this subsection unless--
                    ``(A) before the date that is 2 years after the 
                date of the enactment of this subsection, the Secretary 
                makes a final written determination that the holder of 
                the approved application has demonstrated that there is 
                a reasonable certainty of no harm to human health due 
                to the development of antimicrobial resistance that is 
                attributable in whole or in part to the nontherapeutic 
                use of the drug; or
                    ``(B) before the date specified in subparagraph 
                (A), the Secretary makes a final written determination 
                under this subsection, with respect to a risk analysis 
                of the drug conducted by the Secretary and other 
                relevant information, that there is a reasonable 
                certainty of no harm to human health due to the 
                development of antimicrobial resistance that is 
                attributable in whole or in part to the nontherapeutic 
                use of the drug.
            ``(3) Exemptions.--Except as provided in paragraph (5), if 
        the Secretary grants an exemption under section 505(i) for a 
        drug that is a medically important antimicrobial, the Secretary 
        shall rescind each approval of a nontherapeutic use in a food-
        producing animal of the medically important antimicrobial as of 
        the date that is 2 years after the date on which the Secretary 
        grants the exemption.
            ``(4) Approvals.--Except as provided in paragraph (5), if 
        an application for a drug that is a medically important 
        antimicrobial is submitted to the Secretary under section 
        505(b), the Secretary shall rescind each approval of a 
        nontherapeutic use in a food-producing animal of the medically 
        important antimicrobial as of the date that is 2 years after 
        the date on which the application is submitted to the 
        Secretary.
            ``(5) Exceptions.--Paragraph (3) or (4), as the case may 
        be, shall not apply if--
                    ``(A) before the date on which approval would be 
                rescinded under that paragraph, the Secretary makes a 
                final written determination that the holder of the 
                application for the approved nontherapeutic use has 
                demonstrated that there is a reasonable certainty of no 
                harm to human health due to the development of 
                antimicrobial resistance that is attributable in whole 
                or in part to the nontherapeutic use in the food-
                producing animal of the medically important 
                antimicrobial; or
                    ``(B) before the date specified in subparagraph 
                (A), the Secretary makes a final written determination, 
                with respect to a risk analysis of the medically 
                important antimicrobial conducted by the Secretary and 
                any other relevant information, that there is a 
                reasonable certainty of no harm to human health due to 
                the development of antimicrobial resistance that is 
                attributable in whole or in part to the nontherapeutic 
                use of the medically important antimicrobial.
            ``(6) Definition.--In this subsection:
                    ``(A) 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, or cephalosporin; 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).
                    ``(B) The term `therapeutic use', with respect to a 
                medically important antimicrobial, means the use of 
                antimicrobials for the specific purpose of treating an 
                animal with a documented disease or infection. Such 
                term does not include the continued use of such an 
                antimicrobial in the animal after the disease or 
                infection is resolved.
                    ``(C) The term `nontherapeutic use'--
                            ``(i) means administration of antibiotics 
                        to an animal through feed and water (or, in 
                        poultry hatcheries, through any means) for 
                        purposes (such as growth promotion, feed 
                        efficiency, weight gain, or disease prevention) 
                        other than therapeutic use or nonroutine 
                        disease control; and
                            ``(ii) includes any repeated or regular 
                        pattern of use of medically important 
                        antimicrobials for purposes other than 
                        therapeutic use or nonroutine disease control.
                    ``(D) The term `noncustomary situation' does not 
                include normal or standard practice and conditions on 
                the premises that facilitate the transmission of 
                disease.
                    ``(E) The term `nonroutine disease control' means 
                the use of antibiotics on an animal that is not sick 
                but where it can be shown that a particular disease or 
                infection is present, or is likely to occur because of 
                a specific, noncustomary situation, on the premises at 
                the barn, house, pen, or other level at which the 
                animal is kept.''.

SEC. 5. LIMITATIONS ON USE OF MEDICALLY IMPORTANT ANTIMICROBIALS FOR 
              NONROUTINE DISEASE CONTROL.

    (a) Prohibited Acts.--Section 301 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 331) is amended by adding at the end the 
following:
    ``(ccc) The administration of a medically important antimicrobial 
to a food-producing animal for nonroutine disease control in violation 
of the requirements of section 512A.''.
    (b) Requirements.--Chapter V of the Federal Food, Drug, and 
Cosmetic Act is amended by inserting after section 512 of such Act (21 
U.S.C. 360b) the following:

``SEC. 512A. LIMITATIONS ON USE OF MEDICALLY IMPORTANT ANTIMICROBIALS 
              FOR NONROUTINE DISEASE CONTROL.

    ``(a) Prohibition.--It shall be unlawful to administer (including 
by means of animal feed) a medically important antimicrobial to a food-
producing animal for nonroutine disease control unless--
            ``(1) there is a significant risk that a disease or 
        infection present on the premises will be transmitted to the 
        food-producing animal;
            ``(2) the administration of the medically important 
        antimicrobial to the food-producing animal is necessary to 
        prevent or reduce the risk of transmission of the disease or 
        infection described in paragraph (1);
            ``(3) the medically important antimicrobial is administered 
        to the food-producing animal for nonroutine disease control for 
        the shortest duration possible to prevent or reduce the risk of 
        transmission of the disease or infection described in paragraph 
        (1) to the animal; and
            ``(4) the medically important antimicrobial is 
        administered--
                    ``(A) at a scale no greater than the barn, house, 
                or pen level; and
                    ``(B) to the fewest animals possible to prevent or 
                reduce the risk of transmission of the disease or 
                infection described in paragraph (1).
    ``(b) Definitions.--In this section:
            ``(1) The term `food-producing animal' means a food-
        producing animal intended for sale in interstate commerce.
            ``(2) The terms `medically important antimicrobial' and 
        `nonroutine disease control' have the meanings given to such 
        terms in section 512(q).''.
    (c) Applicability.--The amendments made by this section apply 
beginning on the date that is 6 months after the date of the enactment 
of this Act.