The FDA's Willful Evasion of Science

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Decisions about drug safety should depend on the evidence, not agency resources.

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Dairy cows feed from a trough in Chino, Calif. (Alex Gallardo/Reuters)

The Food and Drug Administration (FDA) is now 0 for 2. In March, a United States magistrate judge ordered the agency to begin withdrawing approvals for most uses of penicillin and tetracycline antibiotics in animal feed. On Monday, the same judge ordered the FDA to reconsider its recent denial of two petitions submitted by public health advocates in 1999 and 2005. The petitions urge FDA to withdraw approvals not just for penicillin and tetracycline, but also for a wide range of antibiotics needed to treat human infections.

In covering the decision, the media have highlighted a few pithy quotes from the judge's opinion. "For over thirty years," he wrote, "the Agency has been confronted with evidence of the human health risks associated with the widespread subtherapeutic use of antibiotics in food-producing animals...[but] the Agency has done shockingly little to address these risks."

Why has a key public health agency done so little despite so much scientific evidence of a public health threat? An old proverb--you can lead a horse to water but you can't make it drink--comes to mind. The FDA certainly has been confronted with scientific evidence of the human health risks, but the agency has routinely set aside the science when making decisions. The ruling does not guarantee that the FDA will do what the petitioners have asked of the agency, but it does require the agency to base its decisions on science.


A Call to Inaction

Notable in the debate over the misuse of antibiotics in food animal production is that the medical and public health communities have long agreed on the science. Decades of research have demonstrated that misuse of these drugs by the food animal industry promotes the development of antibiotic-resistant bacteria that can contaminate the food we eat and the air, water, and soil surrounding the industrial operations that produce these animals.

Many of these bacteria can cause human infections that are harder and more expensive to treat, and in some cases, no effective treatments are available. One resistant pathogen, methicillin-resistant Staphylococcus aureus (MRSA), causes more than 94,000 invasive infections and kills more than 18,000 people each year in the U.S. Long associated with hospitals, MRSA is now increasingly acquired in the community, and emerging evidence has associated proximity to industrial food animal production sites with increased risk of infection. Health economists estimate that antibiotic resistance adds between $16.6 and 26 billion to the nation's health care bill each year.

In 1999, advocates urged the agency to withdraw approvals for the use of key antibiotics to make food animals grow faster and reduce infections linked to the overcrowded and unsanitary conditions in which most food animals are raised. In 2005, advocates sought the withdrawal of approvals for agricultural uses of antibiotics that even the FDA does not consider safe. Both petitions cited the scientific literature extensively, building strong cases for agency action.

Under federal law, the FDA must withdraw its approvals for uses of animal drugs if the agency finds those uses are no longer safe within the meaning of the law. To withdraw an approval, the agency must compile evidence about the safety of the use in question and hold a hearing at which the company that manufactures the drug can contest the withdrawal. If the company cannot convince the presiding administrative law judge that the use in question is safe, the approval is withdrawn.

That is how the FDA is supposed to regulate drugs: assess the scientific evidence to determine whether an approved use is safe or not, and withdraw the approval if it is not. That is what the agency routinely does with human drugs, and it is precisely what the 1999 and 2005 petitions sought.

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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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