The FDA Enters Withdrawal: The Future of Antibiotics on Farms

Studies have tied the misuse of antibiotics on factory farms to the rise of resistance, but the FDA keeps delaying action. Is it too late now?

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Last week, a U.S. district court judge ordered the Food and Drug Administration (FDA) to move forward on ending the use of several antibiotics in food animals except to treat disease. In doing so, the court sent a clear message to the agency: do your job.

Although hundreds of peer-reviewed papers from decades of scientific research have linked the misuse of antibiotics on farms to the rise of antibiotic resistance that now threatens the public health, the FDA has pursued a strategy of "voluntary reform," politely asking drug companies to change their ways but not requiring them to do so. Last Thursday, the judge rebuked the FDA for its passive approach and demanded that the agency follow through on banning uses of drugs by industrial food animal producers that even its own experts no longer consider safe.

THE SCIENCE IS CLEAR

The vast majority of antibiotics in this country -- about 80 percent -- are sold for use in food animal production, not to treat humans. The vast majority of animals that receive these drugs are not sick, and the doses they receive would be too low to successfully treat bacterial infections if they were. Rather, low doses of antibiotics are fed to healthy animals throughout their lives to speed their growth and to reduce infections in the overcrowded and unsanitary conditions commonly found at the industrial operations that produce these animals.

The use of antibiotics for disease prevention is only necessary because companies have chosen to raise animals using methods that make them especially susceptible to infectious diseases.

Using antibiotics this way continuously exposes bacteria to low doses of these drugs, providing an ideal environment for the emergence of antibiotic-resistant bacteria that can infect humans on farms, in the environment, and in the food we eat. For this reason, physicians and scientists have long sought restrictions on the agricultural use of antibiotics.

Likewise, the World Health Organization (WHO) has highlighted the misuse of antibiotics in food animal production when warning of a "post-antibiotic era" in which drugs are no longer effective and currently manageable infections, left untreated, turn deadly.

DECADES OF INACTION

In 1977, the FDA determined that using penicillins and tetracyclines to make animals grow faster was no longer "shown to be safe," as research had linked such uses to the development of antibiotic resistance. The agency began the process of withdrawing their approvals, publishing what it calls "notices of opportunity for a hearing."

Such notices, the first step in any withdrawal process, set out the rationale for the withdrawal and allow companies that manufacture the drugs to request an administrative hearing to contest the FDA's decision. At these hearings, companies bear the burden of proof and must show that the uses in question are safe. If they cannot, the agency withdraws its approval.

The FDA never held a hearing in 1977, however. Under pressure from Congress, the agency backed down, leaving the approvals in place. Although the FDA did not rescind the notices, in theory leaving the matter open for future consideration, the agency took no further action to restrict either drug class for the next 34 years.

Frustrated by the FDA's lethargy, consumer advocacy groups petitioned the agency in 1999 and again in 2005 to complete the process it had begun three decades earlier. The FDA ignored both petitions until the groups sued for action last year. The agency denied both petitions in response. The FDA then withdrew the notices on penicillins and tetracyclines, claiming it would pursue "other regulatory strategies" to address antibiotic resistance instead.

These "regulatory strategies" have been entirely voluntary. In 2010, the agency released a draft guidance document that described how antibiotics should -- and should not -- be used on farms to minimize selection for antibiotic resistance. Notably, the FDA wrote that using antibiotics for growth promotion "is not in the interest of protecting and promoting the public health." The agency nevertheless described using antibiotics to prevent infections as "necessary and judicious." That is, the FDA endorsed feeding low doses of antibiotics to food animals throughout their lives to prevent infections, if not to promote growth. This practice has time and again been shown to select for antibiotic resistance.

Presented by

Dr. Robert S. Lawrence is professor of Environmental Health Sciences, Health Policy, and International Health at the Johns Hopkins Bloomberg School of Public Health, and founding director of the Center for a Livable Future.

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