FDA Reverses Ban on Extralabel Use of Antibiotics

Just a few months after prohibiting the extralabel use of cephalosporin antimicrobial drugs in animals used for food, the Food and Drug Administration has reversed itself. In July, 2008, the FDA declared the extralabel use of these drugs "presents a risk to the public health". 

The FDA explained, "Under C.F.R. § 530.3(e), this means that we have evidence demonstrating that the use of the drug has caused, or likely will cause an adverse event."

The FDA feared extralabel use of these drugs would lead to strains of foodborne bacteria resistant to antibiotics, including e. coli and salmonella. According to the FDA in July, 2008, "If these drug-resistant bacterial strains infect humans, it is likely that cephalosporins will no longer be effective for treating disease in those people….Given the importance of the cephalosporin class of drugs for treating disease in humans, FDA believes that preserving the effectiveness of such drugs is critical. Therefore, FDA believes it is necessary to take action to limit the extent to which extralabel use of cephalosporin in animals may be contributing to the emergence of resistant variants.

FDA is particularly concerned about the extralabel use of cephalosporins in food-producing animals given that such animals are known reservoirs of foodborne bacterial pathogens such as Salmonella. Based on information regarding cephalosporin resistance as discussed previously, FDA believes it is likely that the extralabel use of cephalosporins in food-producing animals is contributing to the emergence of cephalosporin-resistant zoonotic foodborne bacteria. Therefore, FDA has determined that such extralabel use likely will cause an adverse event and, as such, presents a risk to the public health." 73 FR 38110

That was then. Now, under intense pressure from industry groups as well as the American Veterinary Medical Association, the FDA has decided not to implement the prohibition pending further study.   

What this means

Extralabel drug use means a veterinarian has prescribed a drug for a use not approved by the FDA: a human drug given to animals, a drug for one species that is used on a different species, use of a drug for one condition to treat another condition.  

The Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA) amended the Federal Food, Drug, and Cosmetic Act to permit licensed veterinarians to prescribe extralabel uses of approved drugs. 21 CFR part 530. The FDA has the authority, though, to limit these uses.

For the most part, these antibiotics are not used to treat animals used for food for illness, disease, injury or other therapeutic purposes.  According to a 2000 study, "Hogging It!; Estimates of Antimicrobial Abuse in Livestock", Union of Concerned Scientists, approximately 70%  of all antibiotics and related drugs are given to animals used for food as a feed additive to enhance growth and to guard against illness or disease in the unsanitary and crowded conditions these animals are subjected to in today’s agricultural methods.  This is 8 times the amount of antibiotics used on humans.

As a result, according to recent studies, extralabel, non-therapeutic overuse of antibiotics has led to antibiotic resistant diseases in humans.

In other words, human health has been jeopardized to protect the profitability of agri-business, of CAFOs. Not to mention the cruelty to farm animals enabled by these practices.   

For more on studies of antibiotic-resistant bacteria that threaten human health as a result of extralabel, non-therapeutic overuse of antibiotics in food animals…..