This is a joint post with Kim Elliott and Rifaiyat Mahbub.
After years of growing concern that the extensive use of antibiotics in animals was leading to the spread of drug-resistant infections, the US Food and Drug Administration (FDA) has issued a final guidance document that seeks to eliminate the use of critical antibiotics to promote growth in animals. This is an important but modest step forward for the FDA. In 2011 the FDA reported that 29.9 million pounds of antibiotics were sold for use in livestock – this represents 80 percent of the total volume of antibiotics sold in the US. The FDA is hoping that by limiting the use of antibiotics for growth promotion it can slow the emergence of drug resistant bacteria. But experience suggests the new FDA rules may contain a fat loophole.
A number of key reports highlight drug resistance as a major challenge of our time. The Center for Disease Control and Prevention’s Antibiotic Resistance Threats report estimated that in the past year, approximately 2 million people were infected with bacteria that were resistant to antibiotics and that at least 23,000 deaths could be attributed to antibiotic-resistant infections each year. A CGD report warned in 2006 that the useful life of antibiotics has been getting shorter and shorter, as resistance appears more and more rapidly.
Members of Congress have proposed legislation that would require the FDA to take steps toward withdrawing approval for all nontherapeutic use of drugs in animals (the use of drugs for a purpose other than treatment of disease, e.g. growth promotion and disease prevention). Until FDA’s new plan, the United States had resisted undertaking even modest policy changes in this area. By comparison, the European Union banned the use of antibiotics for growth promotion in 2006.
While the FDA’s new plan offers a ray of hope to those concerned about the widespread use of antibiotics, it is a basic first step. First, the plan is voluntary. Drug companies are encouraged, not required, to revise antibiotic labels to clarify that drug use is allowed only when medically necessary and not for growth promotion, but drugs can still be used to prevent (rather than just treat) infections. While several pharmaceutical companies have agreed to change their drug labels, the disease prevention loophole is a large one.
In the Netherlands, a ban on antibiotic use for growth promotion alone had little impact on farmer behavior and the volume of antibiotic use remained fairly constant during the initial years. Later, stricter regulations that instituted limits on total use and imposed fines to penalize noncompliance brought about small decreases in antibiotic use. By contrast, Denmark, a pork production powerhouse, banned antibiotic use in animals for all nontherapeutic purposes in 1999; including growth promotion and disease prevention. Result: use of antibiotics per pound of Danish meat dropped by half. The Danish government also collects extensive data on antibiotic sales, so the use of antibiotics can be traced back to individual livestock producers.
We are encouraged that the FDA is finally moving to combat the looming threat of drug resistance, but these examples suggest that this initial response is unlikely to be enough to bring about large reductions in unwarranted antibiotic use. To take it a step further, the United States should, like the Danish government, prohibit all non-therapeutic use, for growth promotion and disease prevention, and systematically track antibiotic sales and use.
Antibiotic use in livestock is not unique to Europe and the United States. For example, China is believed to use four times more antibiotics on animals than the United States. Unfortunately, data in China is even harder to find. This is a global challenge. All countries need to come together to reach an international agreement on principles for responsible livestock production, including rigorous monitoring of antibiotic use, so that the effectiveness of the world’s antibiotics are preserved and a post-antibiotic world is postponed. The US FDA move is welcome, but falls short of what is needed to protect Americans and to provide global leadership.