Weak Medicine

Why the FDA's Guidelines Are Inadequate to Curb Antibiotic Resistance and Protect Public Health

Antibiotic-resistant bacteria infect more than 2 million people per year in the United States, causing more than 23,000 deaths. State governments, the FDA and other branches of the federal government should take steps to protect human health from the antibiotic-resistant bacteria that can develop on factory farms.


U.S. PIRG Education Fund

Millions of Americans rely on antibiotics every year to treat infections, but unfortunately, many antibiotics are no longer working against some bacteria prevalent today. Antibiotic-resistant bacteria infect more than 2 million people per year in the United States, causing more than 23,000 deaths.

Since the discovery of penicillin, scientists have known that the overuse of antibiotics can create antibiotic-resistant bacteria, rendering important medicines unable to fight infections. That knowledge, however, has not stopped industrial agriculture from becoming the biggest consumer of antibiotics in the United States. Livestock are fed antibiotics so that they grow faster with less feed and can remain healthy in the unsanitary, disease-laden conditions common on factory farms.

The Food and Drug Administration (FDA) has asked pharmaceutical companies to voluntarily stop the sale of antibiotics to farms for animal “growth promotion.” Unfortunately, the FDA’s action – which will change the labels used on some antibiotics – is unlikely to put a serious dent in antibiotic use in factory farms. Without a reduction in the antibiotics fed to livestock, the development and spread of antibiotic-resistant bacteria will not slow down.

In December 2013, the FDA published recommendations in an attempt to reduce the use of antibiotics on factory farms.

  • Under Guidance for Industry #213, pharmaceutical companies will voluntarily remove labels from antibiotics that authorize the drugs to be fed to animals to make them grow faster with less feed. In addition, fewer antibiotics will be available over the counter and more will require a veterinarian’s approval before being added to animal feed or water.
  • However, the FDA has also proposed changes to the rules regarding veterinary oversight. Under proposed revisions to rules concerning the veterinary-client-patient relationship, veterinarians may be allowed to prescribe antibiotics without having visited the facility or examined the animal in the recent past.

Unfortunately, the FDA recommendations are unlikely to significantly reduce the use of antibiotics on factory farms.

  • Farmers purchase the vast majority of antibiotics under FDA rules that allow them to feed drugs to their livestock to prevent diseases. According to a trade group of animal pharmaceutical companies, only 10 to 15 percent of antibiotics are currently purchased under the rules that allow farmers to feed their livestock drugs for growth promotion.
  • All classes of antibiotics that can be fed to livestock to promote growth can also be used to prevent diseases for chickens, cows and pigs. Therefore, in many cases, factory farms may continue feeding these antibiotics to livestock – even if they had previously been used for growth promotion – simply by claiming that the drugs are for disease prevention purposes.

Pharmaceutical companies do not believe the FDA’s recommendations will meaningfully reduce sales of antibiotics.

  • In a presentation to shareholders, the CEO of Zoetis, the largest animal health company in the country, claimed, “Zoetis supports the U.S. FDA’s efforts, and … we don’t expect this to have a material impact on our future financial results.”
  • The president of the animal health division of Eli Lilly, the fourth largest animal pharmaceutical company in the country, stated “we do not see this announcement being a material event.”
  • According to Bimeda, another animal pharmaceutical company, “growth uses of medically important antibiotics represent only a small percentage of overall use, so even if all other factors are static it’s unlikely overall use would be greatly affected” by the new FDA guidelines.

Experience with similar rules in Europe shows that the FDA should have implemented stronger recommendations.

  • From 1972 to 2006, European regulators took action similar to the FDA’s by banning the practice of feeding antibiotics to animals for “growth promotion.” In the Netherlands – which keeps records of antibiotic consumption – the total use of antibiotics fed to animals did not decline because farms increased the antibiotics fed to animals for “disease prevention.” In 2011, the European Parliament adopted a resolution stating that the ban was insufficient to protect human health from the overuse of antibiotics.
  • With the ban on antibiotics for growth promotion failing to reduce the overuse of antibiotics on factory farms, the Netherlands enacted regulations, embraced by industry, calling for a 70 percent decline in antibiotic consumption by 2015. As a result, the amount of antibiotics fed to animals for therapeutic uses, such as disease prevention, dropped by more than 50 percent over five years.
  • From 1994 to 1999, Denmark took a series of steps that led to a ban on the practices of feeding animals antibiotics for “growth promotion” and “disease prevention.” Consequently, farmers adopted better practices to prevent disease, such as allowing piglets to nurse longer before being weaned. As a result, from 1992 to 2008, use of antimicrobials declined 51 percent on pig farms while pork production increased 47 percent, and antimicrobial use declined 90 percent on chicken farms, even as production increased slightly.

State governments, the FDA and other branches of the federal government should take steps to protect human health from the antibiotic-resistant bacteria that can develop on factory farms. Specifically, these authorities should:

  • Restrict the use of antibiotics in livestock production to cases of animal sickness or direct disease exposure. The use of antibiotics on factory farms for “disease prevention” should be banned.
  • Ban the farm use of certain antibiotics that are especially valuable to human medicine, including fluoroquinolones, glycopeptides, macrolides, and third- and fourth-generation cephalosporins – all considered critically important by the World Health Organization.
  • Create transparency over the antibiotics fed to animals by managing a registry of industrial farms’ usage of antibiotics. The registry should be accessible online and provide the public with information on the types, doses and purposes of antibiotics administered farm-by-farm.
  • Require that the administration of antibiotics to animals on factory farms be overseen by a qualified veterinarian who has been to the farm or ranch and assessed the animals.
  • Provide funding for research and development of antibiotic and non-antibiotic treatments. As today’s antibiotics become less effective in treating infections, scientists and pharmaceutical companies should be encouraged to discover new antibiotic classes to cure human diseases.