Advocacy in action – Recent activities with FDA and CDC

Advocacy in action

Recent activities with FDA and CDC

I thought I would take this opportunity to update you about our recent advocacy efforts with the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). They are both examples, I think, of the need to stay involved and make your voice heard. While we still may not always get what we want, hopefully we can raise the level of awareness and at least work to minimize any adverse impacts to our profession or the industry we work with.

Food and Drug Administration

As you may recall, the US FDA issued an order back in 2008 banning all extra-label uses of cephalosporins in food-producing animals. As a result of the comments received by the agency from groups like AASV, the FDA rescinded that order and agreed to reconsider the scope of the proposed ban. On January 6, 2012, the agency issued order FDA-2008-N-0326 prohibiting certain uses of cephalosporins in food-producing animals. If enacted, this order would prohibit the extra-label use of cephalosporin antimicrobial drugs (not including cephapirin) in cattle, swine, chickens, and turkeys: (1) for disease prevention purposes; (2) at unapproved doses, frequencies, durations, or routes of administration; and (3) if the drug is not approved for that species and production class. Unless delayed or rescinded, the order will become effective on April 5, 2012.

What this means for swine:

1. Cephalosporins may continue to be used as labeled without additional restriction.

2. Veterinarians may prescribe cephalosporins for use in an extra-label manner for indications (diseases or conditions) not listed on the label as allowed within the confines of the Animal Medicinal Drug Use Clarification Act.

3. Cephalosporins prescribed for extra-label indications may only be used at the dose, frequency, duration, and routes of administration approved on the product label. Thus, for example, oral administration of cephalosporins in swine would be illegal.

4. Use of cephalosporins for the prevention of disease is prohibited.

5. Use of cephalosporin drugs intended for humans or companion animals in food-producing animals is illegal.

The FDA may issue a prohibition order if it finds that extra-label use of a drug in animals presents a risk to the public health. This means if FDA has evidence demonstrating that the use of the drug has caused, or likely will cause, an adverse event. In the case of cephalosporins, the agency is prohibiting extra-label uses in food-producing major species because they “believe such uses in these animals will likely cause an adverse event in humans and, therefore, present a risk to the public health.” In the case of swine, the agency provided no information supporting their “belief” that current extra-label use practices actually result in any increased risk to human health. In comments submitted to the agency by AASV in response to this order, we requested that FDA reconsider these additional restrictions on the use of cephalosporins in swine or provide justification for these restrictions.

We also expressed particular concern with the restriction on the preventive use of cephalosporins in swine. Swine veterinarians work very closely with producers to develop detailed herd-health plans based on frequent diagnostic submissions and herd analysis. Prevention and control of disease are the result of a multi-faceted effort involving bio-security, facility design, environmental control, management strategies, proper nutrition, vaccination, and diagnostics. Antimicrobials are utilized as a last resort due to their cost and concerns regarding resistance and violative residues. We emphasized the necessity of allowing swine veterinarians the ability to utilize antimicrobials in a judicious and extra-label manner to protect and promote animal health, public health, and food safety.

CDC Influenza Division

I wanted to bring you up to speed on our interactions with the CDC Influenza Division. We have been working in collaboration with Dr Jennifer Koeman at the National Pork Board and our partners at USDA to promote a spirit of cooperation and collaboration with folks in the Influenza Division of CDC. I have to say that I think we have come a long way in raising the level of understanding within both the public-health and animal-health sides of the influenza topic, largely due to the willingness of the CDC leadership and to the persistence of Dr Koeman. The support of USDA (Drs Dave Pyburn, John Korslund, and Tom Gomez) has also been very helpful.

You may have noticed recently that CDC is participating in an effort to change the nomenclature associated with the naming of influenza viruses. The secretary of agriculture even weighed in on this issue in support of efforts to remove the term “swine-origin” from the common nomenclature used to reference influenza isolates where possible. We had a series of discussions with CDC regarding the impact on pork producers when swine were implicated as the “cause” of an influenza outbreak because of the use of “swine-origin” in the scientific nomenclature. The use of this terminology is often misleading to the general public and frequently adds nothing of practical value to the designation of influenza strains or adaptations. Following discussions among the World Health Organization, the World Organization for Animal Health, the Food and Agriculture Organization, CDC, and other US federal agencies, swine-origin influenza viruses identified in humans will now be referred to as “variant” viruses and denoted with a “v.” Influenza viruses identified in swine populations will continue to be referred to as “swine influenza” viruses.

I think this is an example of cooperation between various government agencies, international organizations, the scientific community, and the swine industry to raise the level of understanding about an issue of concern and to derive a solution acceptable to all parties. I would like to think that, at least in some small way, the outreach efforts of the National Pork Board and AASV contributed to raising the level of awareness and stimulated the willingness of the parties to consider the sensitivities associated with animal agriculture and influenza. Jennifer and I will be glad to take credit until someone tells us to stop.