Running Head: S.1256 1 Health Policy Analysis S. 1256: Preventing Antibiotic Resistance Act of 2013 Tanya Staton Concordia University October 24, 2013 S.1256 2 For the last 70 years antibiotics or antimicrobial agents have greatly reduced morbidity and mortality. With the misuse and overuse of antibiotics, bacteria are becoming more resistant and drugs that were once deemed effective and are no longer working. Antibiotic resistance is bad for a number of reasons. It increases healthcare costs, limits treatment options and can increase the duration and number of infections individuals can have. The Center for Disease Control and Prevention (CDC) estimates that two million Americans become sick every year because of antibiotic-resistant bacteria and out of those two million roughly 23,000 will die from the infections (Tavernise, 2013). The United States Congress recognized that antibiotic overuse was becoming an issue in human medicine and made amendments to the Public Health Service Act made by section 102 of the Public Health Threats and Emergencies Act. Legislation has been passed addressing misuse and overuse of antibiotics concerning human consumption, but legislation involving antibiotic abuse in agriculture is still limited even though antibiotics have been used in livestock since the 1940s. Preventing Antibiotic Resistance Act of 2013 also known as S. 1256 is a bill that was signed by a congressional committee on June 27, 2013 in hopes to become law. The basis of this bill is 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 (S. 1256, 2013). Antibiotics are severely overused and abused in human medicine and in agriculture. Farmers are providing their livestock with antibiotics to promote growth and decrease the animal’s chances of infection, but in doing so they are allowing bacteria to adapt and become resistant to antibiotics that are currently on the market to reduce S.1256 3 morbidity and mortality. The Alliance for the Prudent Use of Antibiotics states that “most livestock encounter antimicrobials either by feed, water or injection at some point during their lives (Science of Resistance: Antibiotics of Agriculture, 2013). In 2011, a staggering 29.9 million pounds of antibiotics were administered for agriculture purposes and only 7.3 million pounds were used for humans (Wallinga, 2013). Antibiotics have also been discovered in 48 percent of streams tested nationwide and roughly half of the streams that tested positive for antibiotics were near an agricultural operation (S. 1256, 2013). Antimicrobials for agricultural are identical or closely resemble those used for humans, so if bacteria can become resistant to agricultural antibiotics the odds are good that they will also be resistant in humans. The CDC recognizes the emerging public health threat of antimicrobial resistance. The CDC established the National Antimicrobial Resistance Monitoring System (NARMS) to track antimicrobial resistance in foodborne and other enteric bacteria. NARMS tracks data on agricultural antibiotic resistance and has developed Get Smart on the Farm Goals. These goals include promoting appropriate use of antibiotics through education, communication and collaboration while serving as a liaison among the public health community, veterinarians and food animal producers. Another major initiative the program is trying to achieve is supporting veterinary school curriculum to teach the importance of not prescribing antibiotics unless necessary (cdc.gov, 2013). The provisions to bill S. 1256 will first include addressing the issue of administering antibiotics for routine use. Humans do not consume antibiotics when they are not-ill so animals should not be given them unless absolutely necessary. Section 512 of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 360b) is to be amended to S.1256 4 include elimination of nontherapeutic antibiotic use in animals. Some farmers would still like to use antibiotics, so the new bill will also include exemptions and approvals for continuing routine antibiotic use. For example, if the Secretary grants an exemption 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, effective on the date that is two years after the date on which the Secretary grants the exemption. The bill also clearly defines which antibiotics are considered “medically important antimicrobial.” Antibiotics that are considered “medically important” include penicillin, tetracycline, macrolide, lincosamide, streptogramin, aminoglycoside, sulfonamide or cephalosporin. The bill also states that the World Health Organizations publication entitled ‘Critically Important Antimicrobials for Human Medicine’ can also determine if an antibiotic is important. The bill also sets regulations on how the antimicrobial can be administered. The antibiotic can be administered on a scale no greater than a barn or pen level and can only be given to the fewest animals possible to prevent the spread of transmission. Lastly, the bill sets forth provisions for veterinarians. The Senate wants to make sure there is a valid veterinarian/client relationship and that the veterinarian is making appropriate medical judgment when administering antibiotics for agricultural purposes (S. 1256, 2013). Democratic Senator Dianne Feinstein is sponsoring bill S. 1256 along with five other co-sponsors. Since the bill was introduced on June 27, 2013 the bill has been referred to the Senate Health, Education, Labor and Pensions committee, but no other progress has been made. Currently the outcome for this bill does not look promising. There is only a two percent chance the bill will make it past the committee to be able to S.1256 5 be voted by the Senate. Timing is crucial when introducing new bills and because the bill was introduced during the first year of the congressional term it can potentially hurt its chances. Lastly, bill S. 1256 does not have a projected positive outcome because the Senate Health, Education, Labor and Pensions committee enacted only three percent of the bills it referred to between 2011 and 2013. The individuals or groups that will be opposed to this legislation are the agricultural operators and pharmaceutical companies. Currently 80 percent of antibiotic sales in the United States are sold for agricultural purposes (Bottemiller, 2012). Limiting antibiotic use for only therapeutic purposes will greatly reduce sales. Pharmaceutical companies want antibiotic sales to stay high because it correlates with higher profits. Agricultural operators want to keep antibiotics on their farms because using antimicrobials promotes faster and bigger growth in their livestock. The accelerated maturity allows their product to go to market faster. The National Pork Board believes responsible use of antibiotics is necessary to an animal’s health and also essential to public health and the safety of the food chain (The Use of Antibiotics in Pig Farming, n.d.). Overall I think bill S. 1256 is a well-written bill. The policy analyst clearly defined a problem statement, provided factual evidence about antimicrobial resistance and the landscape is clear and easy to follow. However, I think the bill should have included provisions on what violations would be expected if being caught administering antibiotics for non-therapeutic reasons in agricultural purposes. I also feel the bill should have included a brief background of why there is such limited regulation on antibiotics in agriculture. It would have been helpful for the policy analyst to provide examples of how S.1256 6 antibiotic resistance spreads. Below is a diagram that the Center for Disease Control made on antibiotic resistance. http://www.wired.com/images_blogs/wiredscience/2013/09/CDC-AMRgraphic.jpg A recommendation I would have for bill S. 1256 is to include examples of how farmers can phase out antibiotics from their livestock and instead incorporate healthier living quarters for their animals to cut back on disease. Banning or limiting Concentrated Animal Feedlot Operations is a recommendation I would give to help greatly reduce an S.1256 7 animal’s chance of infection. The Food and Drug Administration is pushing for labeling changes for pharmaceutical companies, so another recommendation to include in bill S. 1256 would be for the pharmaceutical companies of the antibiotics to change their labeling to include only use for prevention of disease and not for promoting growth (Bottemiller, 2012). Currently there are 5,721 bills and resolutions being presented before the United States 113th Congress and S. 1256 only has a predicted two percent chance of even making it past the congressional committee (S. 1256, 2013). It is unfortunate that bills that involve our food supply will more than likely never even have a chance to be voted on. I also found a very similar bill that was being voted on by the House of Representatives called the Preservation of Antibiotics for Medical Treatment Act of 2013 also known as H.R. 1150. This bill has a three percent chance of making it past the House Energy and Commerce Committee it has been assigned to and a one percent chance of being enacted. Antimicrobial resistance is a growing and serious public health threat. I constantly see the consequences of antibiotic resistance while working at the hospital. More and more patients are having to be treated with Vancomycin because they have a Staph infection that cannot be treated with Methicillin. I admire bill S. 1256 and what it stands for. Alexander Fleming revolutionized medicine with the discovery of penicillin; there needs to be regulation of antibiotics in humans and in agricultural if we hope to continue to use antibiotics in the future. S.1256 8 Reference: S. 1256--113th Congress: Preventing Antibiotic Resistance Act of 2013. (2013). In www.GovTrack.us. Retrieved October 20, 2013, from http://www.govtrack.us/congress/bills/113/s1256 Bottemiller, H. (2012, April 12). FDA Issues Voluntary Plan to Limit Antibiotics in Agriculture. Retrieved from Food Safety News: http://www.foodsafetynews.com/2012/04/fda-issues-voluntary-plan-to-limitantiotics-in-agriculture/#.UmhVYvmsiSo Center for Disease Control and Prevention (2013, September 17). National Antimicrobial Resistance Monitoring System . Retrieved from Center for Disease Control and Prevention: http://www.cdc.gov/narms/get-smart.html Science of Resistance: Antibiotics of Agriculture. (2013). Retrieved from Alliance for the Prudent Use of Antibiotics: http://www.tufts.edu/med/apua/about_issue/antibiotic_agri.shtml The Use of Antibiotics in Pig Farming. (n.d.). Retrieved from pork cares.org: http://www.porkcares.org/h56hu/index.html?gclid=CJX37MOWrroCFYdQ7Aod BB8Aaw Wallinga, D. (2013, Feburary 12). Animal Antibiotic Use Continues Upwards, FDA Keeps Blinders On . Retrieved from The Huffington Post: http://www.huffingtonpost.com/david-wallinga-md/animal-antibioticuse_b_2654385.html Tavernise, S. (2013, September 16). Antibiotic-Resistance Infections Lead to 23,000 Deaths a Year, C.D.C. Finds. Retrieved from http://www.nytimes.com/2013/09/17/health/cdc-report-finds-23000-deaths-ayear-from-antibiotic-resistant-infections.html