April 11, 2012
FDA seeks veterinary oversight of 'medically important' antibiotics in livestock
Nonbinding proposal would relabel many drugs
By: Jim Downing
For The VIN News Service
The U.S. Food and Drug Administration (FDA) today issued a plan to stop the use of certain antibiotics to fatten livestock and to require veterinary approval for farm uses of antibiotics that the agency deems important to human medicine.
A recent Kansas State University study found that 1.6-million pounds of antibiotics are used annually in the United States to promote growth in pigs.
The action is needed to combat the development of antibiotic-resistant pathogens, the agency said.
The FDA plan would eliminate the use of drugs such as penicillin and tetracyclines for what are known as "production uses" — feeding antibiotics to livestock so that the animals grow slightly faster or require slightly less feed to reach market weight. These antibiotics still would be permitted for the prevention, control and treatment of diseases but only in consultation with a veterinarian.
Currently, livestock producers employ antibiotics for a variety of uses without veterinary oversight.
The plan issued today is not binding, but it has the support of veterinary pharmaceutical makers. Under the plan, drug companies would voluntarily stop selling medically important antibiotics labeled for production uses and add the requirement for veterinary oversight as needed.
Antibiotics for production uses are now typically sold mixed into animal rations as "medicated feed," which is available over the counter. To increase veterinary oversight of these uses, the FDA is proposing that medicated feeds be available only with a veterinary feed directive, or VFD. The VFD is a marketing status distinct from prescription status, but both require veterinary oversight. Current VFD rules include paperwork requirements that veterinary and livestock groups say are onerous; the FDA is in the process of streamlining VFD procedures in response to those concerns.
The FDA reached a formal finding that production uses of medically important antibiotics are unsafe in 1977 and called for a ban. However, resistance from the meat and drug industries and the difficulty of quantifying the risk to human health from such uses stalled action for decades. In March — 35 years later — a federal judge ordered the agency to restart the withdrawal proceedings, noting that in more than three decades, "the FDA has not issued a single statement ... that undermines the original findings that the drugs have not been shown to be safe."
For years, the American Veterinary Medical Association (AVMA) opposed restrictions on food-animal antibiotic use, arguing that there’s no proof that using antibiotics in food animals presents a significant public health risk and that restrictions on the drugs would imperil animal health and food safety. It has also argued that increasing veterinary oversight of antibiotic use on farms would be impractical. Those positions have become contentious within the veterinary profession, and the AVMA has moved to engage with the FDA on the drafting of antibiotic-use policies that include veterinary oversight as well as some restrictions on drug uses.
The AVMA said in a written statement today that it would be "premature" to comment on on the new FDA plan. Spokeswoman Sharon Granskog said the group would provide feedback Thursday.
The National Pork Producers Council released a statement opposing the relabeling plan as well as the requirement for veterinary oversight. The group said small hog farmers in rural areas may not have ready access to a veterinarian.
Public health advocacy groups generally applauded the FDA announcement, though some questioned whether the agency's voluntary enforcement approach would be effective.
The current extent of production uses of antibiotics is unclear because the government does not collect data on the quantities of antibiotics sold for that purpose versus for the prevention, control and treatment of disease. However, U.S. Department of Agriculture reports have suggested that production uses amount to millions of pounds annually. The total consumption of antibiotics by U.S. livestock is roughly 29 million pounds, according to FDA data, compared with about 7 million pounds for medical uses in humans.
Editor's note: This article has been changed from the original to clarify the FDA's proposal to increase veterinary oversight of pharmaceuticals currently sold over the counter as medicated feed.
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