In April 2020, two teams of ProSPER members participated in the National Science Policy Network‘s policy memo competition. This is the memo by Ananya Benegal, Kevin Blake, and Lauren Koenig; the memo by Hannah Frye, Emilee Kotnik, and Rachel Rahn can be found here.
Antibiotics are the foundation of the modern healthcare system, but their continued utility is undermined by antibiotic resistance. Antibiotic resistance is a direct consequence of antibiotic use—both necessary and unnecessary. Therefore, to maintain the utility of these ‘wonder drugs’ immediate action must be taken to eliminate unnecessary use. One major example is disease prevention in healthy food-producing animals. This practice is highly discouraged by the World Health Organization (WHO) because it has dubious effectiveness, but has been definitively shown to promote antibiotic resistance. Several countries and US states already instituted regulations to prohibit using antibiotics for disease prevention in food-producing animals. However, it is still allowed on a national level by the US Food and Drug Administration (FDA). We propose that the FDA amend its antibiotic use guidelines to prohibit all antibiotics from being used for disease prevention in food-producing animals, and set up a fund to sponsor antibiotic resistance education programs.
STATEMENT OF ISSUE
Antibiotics have transformed medicine, curing once-fatal infections and ensuring that invasive surgeries can be performed safely. However, increasing levels of antibiotic resistance have compromised our antibiotic arsenal. Antibiotic resistance is when bacteria have the ability to overcome the drugs designed to kill them. Multidrug-resistant ‘superbugs’ can survive every antibiotic available for treatment. Resistance is observed against nearly all antibiotics, including last-resort drugs used to treat life-threatening infections. Multiple national and global public health organizations categorize antibiotic resistance as an imminent danger 1,2,3,4. In the US alone, more than 2.8 million antibiotic-resistant infections occur annually, resulting in more than 35,000 deaths 2. In short, a ‘post-antibiotic’ era is not a threat for the distant future—we are living in it.
In the US, 80% of antibiotic consumption is for food-producing animals 5. For decades, antibiotics have been unnecessarily given to healthy animals at a constant low dose (e.g., as a supplement to feed) to make them grow faster and prevent disease. This kind of use creates the perfect conditions for resistant bacteria to proliferate, become even more resistant, and then spread to humans (Fig. 1). The scientific consensus is clear: aggressive action must be taken to reduce this kind of unnecessary antibiotic use 6,7,8.
POLITICAL AND LEGAL STATUS
In 2017, the World Health Organization (WHO) released recommendations strongly discouraging the use of antibiotics in food-producing animals for both growth promotion and disease prevention of healthy herds 9. Several countries have already taken action to reduce the use of antibiotics in food-producing animals. The European Union has banned the use of antibiotics as growth promoters since 2006, and in 2018 it passed legislation restricting use for disease prevention to single animals—not entire herds or flocks, as was current practice 10.
In the US, the Food and Drug Administration’s (FDA) classifies ‘medically important’ antibiotics as those important for therapeutic use in humans. Use of medically important antibiotics must be supervised by a licensed veterinarian, and no extra-label uses are permitted. In 2017, the FDA prohibited the use of medically important drugs in food-producing animals for growth promotion; however, use in healthy herds for disease prevention was not prohibited 11. Two states have passed legislation which go beyond current federal rules, and put them in line with the recommendation from the WHO. In 2015, California passed Senate Bill 27, which requires a veterinarian’s prescription for use of antibiotics, and bans use in growth promotion and disease prevention 12. Maryland adopted similar legislation with the Keep Antibiotics Effective Act of 2017 13. Other states are following suit 14, but there is an urgent need for federal regulation that prohibits non-therapeutic use of antibiotics nationwide.
Option 1. Prohibit the Use of Medically Important Antibiotics for Disease Prevention in Food-Producing Animals
We propose amending the CVM GFI #209 Section VII to prohibit the use of medically important antibiotics for disease prevention in food-producing animals 15. Antibiotic use as therapeutic treatment for diagnosed animals would still be permitted, as would use to control spread in a population in which some individuals have been diagnosed. Both uses would require veterinarian supervision, as per existing guidelines.
The FDA amended CVM GFI #209 to instate the 2017 ban on use of medically important antibiotics for growth promotion. Amending it to also prohibit disease prevention is a critical next step to curb unnecessary use of antibiotics, thereby safeguarding their utility. Other countries and several US states have successfully implemented similar bans, demonstrating that this is a feasible option.
Eliminating antibiotic use for disease prevention would require US farmers to transition to more hygienic practices, which could cost up to USD 2.5 billion more per year 16. However, the cost of antibiotic resistance is far greater, currently representing an economic burden of USD 55 billion annually 17.
Option 2. Designate All Antibiotics Used in Food-Producing Animals as Medically Important
We propose amending the CVM GFI #213 Section III to categorize all antibiotics used in food-producing animals as medically important 18. Effectively, this would require supervision by a veterinarian for all antibiotics used in food-producing animals.
Approximately half the antibiotics used in food-producing animals are currently not deemed medically important and so are available over-the-counter 19. However, antibiotic resistance has forced the use of antibiotics previously deemed not medically important. For example, the antibiotic colistin was initially disqualified for use in humans and was used in food-producing animals; however, it is now an antibiotic of ‘last resort’ used for treating multidrug-resistant infections 20. The veterinarian oversight required for antibiotics designated as medically important would lead to more judicious use and greater data collection.
Antibiotics designated medically important would still be able to be used for disease prevention, with the approval of a veterinarian.
iii. Option 3: Create an Antibiotic Education Fund
We propose to create a fund for education programs focused on use of antibiotics in food-producing animals. This would consist of monies taken from a 10% increase in the fees that the FDA collects for use of antibiotics and similar drugs in animals, creating an estimated USD 2 million annually 21.
Farmers are willing to reduce their use of antibiotics when they are confident that they can do so without disrupting their operations 22. Education programs that both explain the need for reduced antibiotic use and provide tools for transitioning to alternate practices would unnecessary reduce antibiotic use without the need for strict regulation. This option would further deter antibiotic use by increasing the cost of antibiotics as a consequence of the fee increase.
The effects an education initiative would not be seen immediately. Further, as the initiative successfully reduces use of antibiotics, there will be a corresponding drop in funding; however, this would match the reduced need for the education initiative.
To most effectively combat the rise of antibiotic resistance, we propose all three options presented above be implemented. Option 1 prohibits the use of medically important antibiotics for disease prevention, Option 2 designates all antibiotics as medically important, and Option 3 creates a fund for education programs. When combined, Options 1 and 2 would prohibit the use of all antibiotics for disease prevention. Enacting all three options will ensure that the issue is addressed in a holistic manner. It would protect the effectiveness of antibiotics that are currently medically important and those that could become medically important, and would facilitate the smooth transition to more sustainable farming practices.
- World Health Organization. Global Action Plan on Antimicrobial Resistance. WHO, May 2015. https://apps.who.int/iris/bitstream/handle/10665/193736/9789241509763_eng.pdf?sequence=1
- Centers for Disease Control and Prevention.Antibiotic resistance threats in the United States, 2019. US Department of Health and Human Services, 2019. https://www.cdc.gov/drugresistance/pdf/threats-report/2019-ar-threats-report-508.pdf
- US Government Accountability Office.Antibiotic Resistance More Information Needed to Oversee Use of Medically Important Drugs in Food Animals. USGAO, March 2017. www.gao.gov/assets/690/683130.pdf
- The Review on Antimicrobial Resistance. Tackling Drug-Resistant Infections Globally: Final Report and Recommendations. May 2016.https://amr-review.org/sites/default/files/160525_Final%20paper_with%20cover.pdf
- Van Boeckel, Thomas P., Charles Brower, Marius Gilbert, Bryan T. Grenfell, Simon A. Levin, Timothy P. Robinson, Aude Teillant, and Ramanan Laxminarayan. “Global trends in antimicrobial use in food animals.” Proceedings of the National Academy of Sciences112, no. 18 (2015): 5649-5654.
- Center for Veterinary Medicine.Supporting Antimicrobial Stewardship in Veterinary Settings: Goals for Fiscal Years 2019-2023. US Food and Drug Administration, September 2018. https://fda.gov/media/115776/download
- Centers for Disease Control and Prevention.Overview and Evidence to Support Appropriate Antibiotic Use. US Department of Health and Human Services, November 2017. www.cdc.gov/antibiotic-use/healthcare/evidence.html
- Tang, Karen L., Niamh P. Caffrey, Diego B. Nóbrega, Susan C. Cork, Paul E. Ronksley, Herman W. Barkema, Alicia J. Polachek et al. “Restricting the use of antibiotics in food-producing animals and its associations with antibiotic resistance in food-producing animals and human beings: a systematic review and meta-analysis.” The Lancet Planetary Health1, no. 8 (2017): e316-e327.
- World Health Organization. WHO guidelines on use of medically important antimicrobials in food-producing animals. WHO, November 2017. https://apps.who.int/iris/bitstream/handle/10665/258970/9789241550130-eng.pdf?sequence=1
- European Parliament. “MEPs back plans to halt spread of drug resistance from animals to humans”. News release, October 25, 2018. European Parliament. Accessed April 14, 2020. https://www.europarl.europa.eu/news/en/press-room/20181018IPR16526/meps-back-plans-to-halt-spread-of-drug-resistance-from-animals-to-humans
- Food and Drug Administration. Veterinary Feed Directive. Health and Human Services, June 3, 2015. https://www.federalregister.gov/documents/2015/06/03/2015-13393/veterinary-feed-directive
- California Legislative Information. Senate Bill No. 27 Livestock: use of antimicrobial drugs.October 10, 2015. http://leginfo.legislature.ca.gov/faces/billTextClient.xhtml?bill_id=201520160SB27
- Maryland General Assembly.Keep Antibiotics Effective Act (SB471/HB652). March 2019. http://mgaleg.maryland.gov/mgawebsite/legislation/details/sb0422?ys=2017rshttp://mgaleg.maryland.gov/mgawebsite/legislation/details/hb0602?ys=2017rs
- New York State Assembly. Bill No. S05742. May 14, 2019. https://nyassembly.gov/leg/?default_fld=&leg_video=&bn=S05742&term=2019&Summary=Y&Memo=Y&Text=Y
- Center for Veterinary Medicine.CVM GFI #209 The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals. US Food and Drug Administration, April 2012. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-209-judicious-use-medically-important-antimicrobial-drugs-food-producing-animals
- National Research Council. “Costs of eliminating subtherapeutic use of antibiotics, Chapter 7.” Committee on Drug Use in Food Animals, Panel on Animal Health, Food Safety, and Public Health, Board on Agriculture, and National Research Council, The Use of Drugs in Food Animals: Benefits and Risk (Washington, DC: National Academies Press, p. 179)(1999).
- Centers for Disease Control and Prevention.Antibiotic resistance threats in the United States, 2013. US Department of Health and Human Services, 2013. https://www.cdc.gov/drugresistance/pdf/ar-threats-2013-508.pdf
- Center for Veterinary Medicine.CVM GFI #213 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.US Food and Drug Administration, December 2013. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-213-new-animal-drugs-and-new-animal-drug-combination-products-administered-or-medicated-feed
- Center for Veterinary Medicine. 2018 Summary Report On Antimicrobials Sold or Distributed for Use in Food-Producing Animals. US Food and Drug Administration, December 2019. https://www.fda.gov/media/133411/download
- Nation, Roger L., and Jian Li. “Colistin in the 21st century.” Current Opinion in Infectious Diseases22, no. 6 (2009): 535.
- Food and Drug Administration. FY 2018 ADUFA Financial Report Required by the Animal Drug User Fee Act of 2003. Health and Human Services, September 2019. https://www.fda.gov/media/131013/download
- Vasquez, Amy K., Carla Foditsch, Stéphie-Anne C. Dulièpre, Julie D. Siler, David R. Just, Lorin D. Warnick, Daryl V. Nydam, and Jaap Sok. “Understanding the effect of producers’ attitudes, perceived norms, and perceived behavioral control on intentions to use antimicrobials prudently on New York dairy farms.” PLOS One14, no. 9 (2019).