Preservation of Antibiotics for Medical Treatment Act of 2015

To amend the Federal Food, Drug, and Cosmetic Act to preserve the effectiveness of medically important antimicrobials used in the treatment of human and animal diseases. 1. Short title This Act may be cited as the Preservation of Antibiotics for Medical Treatment Act of 2015 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 (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 (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. 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. 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) (1) in the first sentence— (A) in subparagraph (H), by striking or (B) in subparagraph (I), by inserting or (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) (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 (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 (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 important Critically Important Antimicrobials for Human Medicine (B) The term therapeutic use (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 (E) The term nonroutine disease control . 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 (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 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 (2) The terms medically important antimicrobial nonroutine disease control . (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.

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’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.