Agriculture Reference
In-Depth Information
In a September 7, 2011, Government Accountability Office (GAO) report, “Antibiotic Resistance:
Agencies Have Made Limited Progress Addressing Antibiotic Use in Animals,” the USDA is quoted as
saying, “Currently, there is insufficient scientific information available to make important policy decisions
regarding use of antibiotics for growth promotion purposes.” 13 Twenty-four public interest organizations
wrote in response to Secretary Vilsack about their “grave concerns” concerning the agency's position, stat-
ing that “USDA has been inconsistent at best in recognizing and accepting the significant scientific evid-
ence supporting the existence of an overuse of antibiotics in animal agriculture.” 14
The group's response went on to note several instances that showed the USDA's refusal to take the life-
threatening loss of antibiotics seriously, including the removal from the USDA's Web site of a July 2011
technical report summarizing the robust literature on antibiotic resistance. At the May 2011 Future of Food
conference at Georgetown University, Vilsack responded to a questioner about what action the agency
would take on antibiotic resistance, stating: “I'm not quite sure. How do you basically legislate that?” He
added, “It's not as easy as it appears.” 15
The real power to limit use of antibiotics, however, resides with the FDA—the agency that approves
the use of the drugs. Among the recent issues the 2011 GAO report addressed was what actions the FDA
has taken to mitigate the risk of antibiotic resistance. The report criticized the FDA for the “lack of crucial
details necessary to examine trends and understand the relationship between use and resistance.” It chas-
tised the FDA for collecting data from drug companies on antibiotics sold for use in food animals without
showing which antibiotics are used or for what purpose. The report summarizes the problem:
FDA . . . faces challenges mitigating risk from antibiotics approved before FDA issued guidance in 2003. FDA
officials told GAO that conducting post approval risk assessments for each of the antibiotics approved prior to
2003 would be prohibitively resource intensive, and that pursuing this approach could further delay progress.
Instead, FDA proposed a voluntary strategy in 2010 that involves FDA working with drug companies to limit
approved uses of antibiotics and increasing veterinary supervision of use. However, FDA does not collect the
antibiotic use data, including the purpose of use, needed to measure the strategy's effectiveness. 16
Pressure mounted on the FDA when, on March 23, 2012, it lost a lawsuit. A federal judge ruled that
the agency must act on a proposal it made in 1977 to prevent two antibiotics important to human medi-
cine—tetracyclines and penicillins—from being given routinely to healthy livestock. After citizen petitions
in 1999 and 2005 and a lawsuit filed in 2011, the FDA took action, quietly withdrawing the proposal just
before Christmas. But the judge ruled that the agency actually had to address the concerns it had identified
over thirty years earlier. Drug manufacturers will have a chance to make their case that the antibiotics are
safe to feed routinely to livestock. But if they aren't able to (and science indicates they won't), the FDA
must withdraw its approval of subtherapeutic uses of the drugs.
Not long after, on April 6, 2012, the FDA banned most subtherapeutic uses of one class of antibiotics,
cephalosporins. These are used to treat food-borne illnesses in humans, especially children, as well as
pneumonia and skin and soft tissue infections. Salmonella resistance to cephalosporin drugs is on the rise,
putting the public at risk.
Five days later, the FDA announced another voluntary initiative to promote the “judicious use” of anti-
biotics in livestock. The agency released the final “Guidance 209: The Judicious Use of Medically Import-
ant Antimicrobial Drugs in Food-Producing Animals,” along with more clarification about how to make
it work. The FDA provided direction for transitioning from the use of over-the-counter antibiotics in an-
imal feed to a new system requiring oversight by veterinarians. But without regulations in place, we have
no guarantee that the pharmaceutical industry and livestock producers will voluntarily stop the use of the
drugs in animals.
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