FDA Denies Activist’s Antibiotic Petition

Dec 05

With consummate speed the Food and Drug Administration has finally replied to the petition to restrict the use of non-therapeutic antibiotics in livestock production submitted in April 2005. The Citizen Petition was drafted by Environmental Defense, the American Academy of Pediatrics, the American Public Health Association, the Food Animal Concerns Trust and the Union of Concerned Scientist.

In denying the petition, FDA noted that statutory requirements must be followed before a new drug approval is withdrawn. The legally-mandated process is complicated and time-consuming requiring the submission of evidence that the compound is potentially harmful as used. Risk assessment and evaluation of specific data is applied internally by the FDA to determine whether the legal process should be initiated to withdraw approval.

Readers are reminded of the process involving the formal administrative hearing with respect to the fluoroquinolone, enrofloxacin which was withdrawn for administration to poultry after an extended process which cost the FDA $3.3 million.

In rejecting the petition FDA cited draft guidance number 209 (The Judicious Use of Medically Important Antimicrobial Drugs and Food-Producing Animals) which establishes principles “aimed at ensuring the judicious uses of medically important antimicrobials in food-producing animals”.

The concluding paragraph of the letter under signature of Leslie Kux, Acting Assistant Commissioner for Policy stated “FDA is committed to working with animal drug sponsors, the veterinary and public health communities, the animal agriculture community, and all other interested stakeholders in developing a strategy to address antimicrobial resistance concerns in a manner which is protective of human and animal health.

Notwithstanding the official response of FDA to Environmental Defense there is growing consumer resistance to routine administration of antibiotics for growth promotion. Alternative probiotic, prebiotic and botanical compounds are under active evaluation. It is becoming apparent that any degradation in field performance of poultry could be compensated for by obtaining a premium for “drug-free” eggs and poultry meat from conscious consumers in high-value specialized markets.

A number of studies are being conducted both at the laboratory and field levels to demonstrate that substitution of non-therapeutic antibiotics is possible from a technical and financial standpoint by a combination of changes in management and supplementing diets with probiotics, prebiotics and botanicals.

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