Industry responds to FDA ruling

 Resize text         Printer-friendly version of this article Printer-friendly version of this article

Geni Wren In a press conference held Wednesday by the Animal Health Institute, the AHI, the American Veterinary Medical Association and the National Pork Producers Council discussed potential impacts of last week’s FDA ruling on antimicrobial use in food animals and increased veterinary oversight.

AHI Vice President of Legislative and Public Affairs Ron Phillips explained that antibiotics used in animals are reviewed and approved by the FDA under the same Food Drug and Cosmetics Act as human drugs. “Animal health companies have to supply the same data packages to provide safety and efficacy information before they can be approved,” he said.

Important to note is that FDA uses four efficacy label claims for antimicrobials in food animals:

  • Treatment of disease
  • Control of disease (such as to keep an outbreak in a flock or herd from spreading)
  • Prevention of disease
  • Growth promotion

The first three are all considered by FDA to be therapeutic claims, i.e. antibiotics acting against a disease or disease-causing agent. Growth promotion is subtherapeutic claim. The Veterinary Feed Directive will require veterinary oversight for antimicrobials that are used in livestock feed. There will be no extralabel use for feed additive antibiotics – they must strictly be on-label, approved uses.

There are some concerns, however, among the groups about the implementation of the VFD. AVMA Assistant Director of Scientific Activities Christine Hoang, DVM, MPH, CPH, said veterinary medicine is the only profession that works at the interface of human and animal health, and must consider the impact of both. “It may be difficult for small or remote producers to get veterinary care, and we are working with the FDA to figure this out.”

NPPC Chief Veterinarian Liz Wagstrom, DVM, said the pork industry has watched what has happened in Denmark when similar regulations took effect.

“From Denmark we learned there are also health benefits to growth promotion uses of antibiotics, and by restricting them we may see more sick animals and a higher cost of production which may or may not translate to higher prices in the meat case," Wagstrom said. "We’ll see negative aspects without an anticipated positive impact to public health. What we saw was an overall small decrease of total antibiotics used in Denmark, but a large increase in the amount of therapeutic use, often in classes considered more important or critical to human health. So think there are potential unintended consequences to these regulations.”

NPPC is supportive of veterinary industry oversight of pharmaceutical use, and Wagstrom pointed to the Pork Quality Assurance program that encourages veterinary participation in drug use on pork operations. However, “We feel that small producers will be disproportionally affected as far as cost of the VFD or access to veterinarians.” Wagstrom said it will be important for NPPC and other veterinary and livestock groups to work with the FDA as these regulations transition over the next few years.

One question was raised about subtherapeutic antibiotics simply being relabeled as a “low-level preventative” and impact on public health. Hoang refuted that notion.

“The AVMA is strongly supportive of therapeutic uses for the sake of animal health and welfare, and that includes treatment, control and prevention. That is also important for food safety. Simply because there is a need for these therapeutic antimicrobials at a low level for prevention that does not mean it poses a risk for human health. They are approved for uses in veterinary medicine by the FDA, and should be available for veterinary medicine. We don’t want people to assume that a preventive use is bad for public health.”

“Animal health is the key to producing safe and healthful protein,” noted Carnevale. “Antibiotics are tools to maintaining healthy animals.”


Prev 1 2 Next All



Comments (0) Leave a comment 

Name
e-Mail (required)
Location

Comment:

characters left