FDA’s Insufficient Response to Antibiotics in Food Animals
by Ronald White, 12/13/2013
UPDATE (Sept. 30, 2014): President Obama issued Executive Order 13676, Combating Antibiotic-Resistant Bacteria, on Sept. 18, 2014. The executive order establishes a federal Task Force for Combating Antibiotic-Resistant Bacteria (Task Force), to be co-chaired by the Secretaries of Defense, Agriculture, and Health and Human Services (HHS), with membership from 11 other federal agencies and departments. The executive order requires the Task Force to submit a five-year action plan outlining specific actions that the various agencies will undertake to implement the National Strategy for Combating Antibiotic-Resistant Bacteria, which was released simultaneously with the executive order. The order also calls for the establishment of a Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria that will provide advice and recommendations to the HHS Secretary on a broad range of issues related to addressing antibiotic-resistant bacteria concerns.
The National Strategy calls for the Food and Drug Administration (FDA) to “take further action as appropriate” after assessing the effectiveness of the December 2013 agency guidance discussed below on eliminating medically important antibiotics for growth promotion in animals. The National Strategy also promotes educational efforts aimed at veterinarians and animal producers to foster antibiotic stewardship and “judicious use” of antibiotics in agricultural settings.
While the executive order and the National Strategy include a number of important steps forward in addressing the rapidly growing threat of antibiotic-resistant bacteria, the executive order as well as the National Strategy and FDA guidance still allow for the use of medically important antibiotics for prevention of disease in food animals. Not surprisingly, the food animal producers spin on the executive order, exemplified by the National Pork Producers Council response, focused on the need more epidemiological research to “understand the key drivers of increased antibiotic resistance” while noting that “all antibiotics used in pork production are approved by FDA.”
Given the economic incentives for pharmaceutical companies to continue sale of antibiotics for disease prevention under the guise of being necessary to “assure animal health” by veterinarians pressured to approve such uses, and large-scale animal food producers’ practice of raising animals in crowded conditions that often lead to disease, there is reason to be skeptical that even the best intentioned efforts to combat the increase in antibiotic-resistant bacteria will succeed.
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.
Update (March 27, 2014): On March 26, the FDA announced that 25 of 26 companies that manufacture antibiotics used in food animal production had agreed to withdraw their drug approvals for use in animal production (i.e., growth promotion) and to relabel their drugs to require veterinary prescription for their use. These 25 companies represent more than 99 percent of the market for antibiotics used in food animal production.
While a potentially significant step in reducing the massive use of antibiotics in food animal production, the companies have up to three years to relabel their drugs and, more significantly, these drugs will still be allowed for preventing (rather than limited to treating) disease in the often overcrowded and unsanitary conditions found in some large-scale animal production facilities. Whether the FDA's voluntary "judicious use" approach will result in a significant reduction in the use of medically important antibiotics in food animal production remains to be seen.
Update (July 30, 2014):On July 24, the U.S. Court of Appeals for the Second Circuit ruled in a split decision that the FDA does not have to consider banning the practice of feeding antibiotics to healthy, food- producing livestock. The ruling was in response to a lawsuit brought by the Natural Resources Defense Council (NRDC) and several other public interest organizations against the FDA’s decision not to hold hearings regarding whether to withdraw their approval of the use of penicillin and tetracycline in animal feed for healthy livestock. NRDC and other groups had submitted petitions to FDA in 1999 and 2005 requesting that FDA hold required hearings and withdraw approval for the use of several antibiotics, including penicillin and tetracycline, in animal feed for healthy livestock.
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