December 18, 2014

FDA Ordered to Reexamine Its Decision to Deny Antibiotic Use Petitions

On June 1, 2012, a federal court ordered the FDA to reexamine its decision to deny petitions that asked the agency to end subtherapeutic use of antibiotics in farm animals.

In 1999, the National Resources Defense Council, the Center for Science in the Public Interest, Food Animal Concerns Trust, Public Citizen, the Union of Concerned Scientists, and the Environmental Defense Fund petitioned the FDA to “rescind approvals for subtherapeutic uses in livestock of any antibiotic used in (or related to those used in) human medicine,” according to the complaint.

The FDA denied this action on November 7, 2011, citing “the time and expense involved in holding a withdrawal hearing,” and that it was “pursuing a different strategy to promote the judicious use of antibiotics in food-producing animals.”

In 2005, the Union of Concerned Scientists, the Environmental Defense Fund, the American Academy of Pediatrics, and the American Public Health Association filed a petition to “withdraw approvals for herdwide/flockwide uses of [certain antibiotics] in chicken, swine, and beef cattle for purposes of growth promotion, disease prevention, and control, except for treating a diagnosed infection.”

Also on November 7, 2011, the FDA denied the petition, saying, again, that they were “pursuing other alternatives to address the issue of antimicrobial resistance related to the production use of antimicrobials in animal agriculture.”

According to Tyler Smith of the Johns Hopkins Center for a Livable Future, those “alternatives” were voluntary guidance documents which simply requested that drug companies stop marketing drugs to farmers, ranchers, and large animal veterinarians for growth promotion.

The denial of a citizen petition by the FDA is subject to judicial review, according to the agency’s own regulations. The Court found that “initiating the withdrawal of approval of a new animal drug is not an enforcement action.” In addition, the FDA is required to “monitor and evaluate data regarding approved new animal drugs and institute withdrawal proceedings if the data shows that the drugs are no longer shown to be safe.”

The court found that the two reasons the FDA gave to deny the petitions:

  • Time and expense required to evaluate individual drug safety and to hold formal withdrawal proceedings if necessary, and
  • Non-binding voluntary measures which the Agency believed would achieve the same result

are not “reasoned justification for the Agency’s refusal to initiate withdrawal proceedings.” The court found that the statute directed the FDA to rescind drug approval if that drug is shown not to be safe has no language stating that the costs of a proceeding are to be used as a guideline for deciding to initiate withdrawal proceedings.

The court also found that the FDA did not address the 3,000 pages of scientific studies attached to the petitions that show the risk of antibiotic resistance development from the use of antibiotics in food-producing animals. Furthermore, there was no evidence that the FDA performed “any risk or safety assessments of the petitioned drugs at all. The Agency simply refused to evaluate the drugs’ safety on the grounds that if withdrawal proceedings were required they would ‘take many years’ and ‘impose significant resource demands.'”

“In effect, the FDA is refusing to follow the statutory mandate of withdrawal proceedings on the ground that such proceedings are not effective because they take too long,” Judge Katz ruled. “Yet, the Petitions at issue have been pending for thirteen and seven years, respectively. Had the Agency addressed the Petitions in a timely fashion, withdrawal proceedings could have been commenced and completed by now.”

We’ll report on the FDA response when it is released.

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