FDA’s Insufficient Response to Antibiotics in Food Animals
by Ronald White, 12/13/2013
The Food and Drug Administration (FDA) released guidance on Dec. 11 that encourages manufacturers of antibiotic drugs used in food-producing animals (e.g., chickens, pigs, cattle) to voluntarily withdraw “medically important” antibiotics from the market by relabeling the products to indicate that their use is approved only for “assuring animal health” rather than for speeding up animal growth as is now often the case. As I’ve noted previously, there is general scientific consensus that the extensive use of antibiotics in the food animal industry has contributed to the increase in antibiotic-resistant diseases in humans. A decade ago, a report from the National Academies of Sciences Institute of Medicine on microbial threats to human health recommended that “the FDA should ban the use of antimicrobials for growth promotion in animals if those classes of antimicrobials are also used in humans” [emphasis added].
If past performance is any indication, the FDA’s voluntary approach to this important public health concern isn’t likely to make a substantial impact on the use of antibiotics in food-producing animals. In 2012 FDA issued a final guidance document as well as a draft version of the current guidance document that included the same two major recommendations as is highlighted in the current document – namely “The use of medically important antimicrobial drugs in food-producing animals should be limited to those uses that are considered necessary for assuring animal health” and “The use of medically important antimicrobial drugs in food-producing animals should be limited to those uses that include veterinary oversight or consultation”.
There was no rush by pharmaceutical companies to change their animal drug approvals in response to those guidance documents. However, as noted in the recent report by the Johns Hopkins Center for a Livable Future, for many of these antibiotics the doses and durations of antimicrobial use for disease prevention are similar or even identical to the doses and durations utilized for production purposes. Given the crowded and often unsanitary conditions found in these large-scale food animal facilities that can lead to disease outbreaks, it’s not surprising that these facilities use these drugs to prevent loss of animals. And the requirement for veterinary oversight is weakened by proposed changes to the FDA’s veterinary feed directive rule issued simultaneously with the new guidance which eliminates the current requirement under the federal code of veterinary professional conduct that would previously have required that the veterinarian providing the prescription for use of antibiotics in animal feed (which is the usual way it’s administered) have a direct connection to the animals being cared for.
FDA touts their voluntary approach as the quickest and most efficient way to change current practice. The final guidance document gives pharmaceutical companies 90 days to let FDA know if they intend to withdraw their current drug label and revise their drug label language through a process known as a supplemental new animal drug application, and then three years to actually make the changes. However, given past history, time will tell whether the shift in usage hoped for by these voluntary guidelines will actually be achieved, or whether companies will simply re-label current antibiotics or market new antibiotics also used for human health as “necessary for assuring animal health”. Unfortunately, for the increasing number of people who are dying or are critically ill from antibiotic-resistant diseases, time is the one thing they don’t have.back to Blog