AASV discusses cephalosporin ban with FDA
Veterinarians representing the AASV met with Food and Drug Administration (FDA) officials on October 8 to discuss the agency’s proposed ban on the extra-label use of cephalosporins. The FDA issued an order effective November 30 that would ban the extra-label use of the cephalosporin class of antimicrobials in food-producing animals. This ban would not affect the approved uses as described on the label. Swine veterinarians, along with other veterinary groups, have expressed multiple concerns with the ban, which prompted swine veterinarians to join the AASV leadership in a meeting at FDA headquarters in Rockville, Maryland.
The group met with Dr Bernadette Dunham, director of the FDA Center for Veterinary Medicine (CVM), and other CVM officials to discuss the agency’s rationale for issuing the order and to express the concerns of swine veterinarians. The CVM is responsible for approval and regulation of veterinary antimicrobials. The Animal Medicinal Drug Use Clarification Act (AMDUCA) governs the extra-label use of antimicrobials and authorizes FDA to restrict such use if the agency determines it to be a threat to public health.
During discussions, the agency reiterated its support for the ban, citing their interpretation of data collected through the National Antimicrobial Resistance Monitoring System (NARMS), results of published studies, and the findings of FDA investigations, along with a healthy dose of precautionary principle. The regulators stated that they considered the cephalosporin class of antimicrobials to be similar to that of the fluoroquinolones with regard to potential importance to human health. They indicated that they had considered banning the extra-label use of cephalosporins by generation rather than the entire class, but determined that would be too cumbersome and was not well defined. The agency did, however, agree to review all comments received during the comment period and left the door open to possibly modifying the order on the basis of the issues brought forth in the comments.
The AASV representatives explained the process swine veterinarians undertake to determine effective treatment regimens for the conditions affecting the food animals they treat. Emphasizing the importance of AMDUCA, they expressed concern regarding the lack of availability of approved products effective in the treatment of a number of conditions encountered on the farm and thus the need for extra-label use in some situations. The veterinarians described the collection and laboratory analysis of diagnostic samples used to establish a therapeutic protocol. They emphasized reliance on their training and understanding of pharmacokinetic properties to properly utilize antimicrobials in a responsible manner, recognizing the public-health concerns as well as the necessity to relieve animal suffering and disease.
The group also questioned the validity of the data used to support the proposed ban. There have long been questions regarding the design and interpretation of the NARMS project, for instance. The NARMS data for pork indicates that the incidence of Salmonella is extremely low and found no cephalosporin resistance in Salmonella isolates from 2004 or 2005. Likewise, the data also showed an extremely low incidence of cephalosporin-resistant Escherichia coli isolates in 2002-2005. In addition, a number of studies have identified the presence of cephalosporin resistance in animals that never received cephalosporins or, in some cases, any antimicrobials at all.
The veterinarians questioned why CVM considers the extra-label use of an approved product for non-labeled indications in the approved species at the approved dosage and route of administration to be a greater risk for development of resistance than the approved labeled use. The response of CVM representatives was that they do not have information regarding the pharmacokinetic profile and safety data for bacteria not approved on the label. It seems, however, that given the fact that antimicrobials affect all susceptible bacteria in the animal being treated, whether or not that bacteria is on the approved label, the more rational approach would be to use an approved product for the species being treated rather than a product labeled for a different species. We have much more information about the pharmacokinetics, tissue distribution, and withdrawal times for products approved for use in a particular species.
The AASV has submitted comments in response to the proposed order and will continue to communicate the concerns of our members to FDA. The original order banning the extra-label use of cephalosporins is available online for review at www.fda.gov/OHRMS/DOCKETS/98fr/E8-15052.htm.
Breaking news: FDA to rescind order
The FDA has announced that it will rescind the order banning the extra-label use of the cephalosporin class of antimicrobials in food-producing animals. The FDA has decided to withdraw the order pending a complete review of the comments received and is planning to re-examine the data upon which the agency based the decision regarding the extra-label use of cephalosporins in food animals. Following this review, the agency may choose to re-issue the order in a full or modified version.
30-day health rule resolved? Finally!
It appears we have finally reached a suitable solution to the issue involving the issuance of Certificates of Veterinary Inspection (CVIs) to weaned pigs born into a herd participating in a herd-health plan that requires an accredited veterinarian to inspect the health status of the herd every 30 days. As you recall, a federal Area Veterinarian in Charge (AVIC) had questioned the practice of issuing a CVI for interstate shipment of weaned pigs moving out of a production flow without actually inspecting the individual pigs, even though the herd participated in a herd-health plan as described in the Code of Federal Regulation.
After much discussion, Dr John Clifford, Deputy Administrator, USDA-APHIS, issued a Veterinary Services Notice in August instructing the AVICs to allow accredited veterinarians to issue a CVI to weaned pigs born into a herd participating in a recognized herd-health plan without further inspection after the third routine 30-day herd-health visit. The Veterinary Services Notice, however, also pointed out that the CVI must accurately reflect the actions of the veterinarian. Most CVIs contain a printed statement that implies or indicates that the animals referenced on the CVI have actually been inspected by the accredited veterinarian. This represents an inconsistency with the policy recognized by USDA: signing a false form would be grounds for regulatory action.
To address the issue of issuing a CVI that accurately reflects the actions of the veterinarian, AASV went before the National Assembly of State Animal Health Officials during their annual meeting on October 25 in Greensboro, North Carolina, to make them aware of this situation. The AASV representatives requested that the assembly consider allowing accredited veterinarians to write an additional statement on the CVI that would explain that the herd, but not necessarily the weaned pigs referenced on the CVI, was inspected within the last 30 days. The assembly members unanimously approved this request.
The assembly did not suggest any official wording, but the intent is to inform the receiving state animal-health officials and recipients of the pigs about the actual inspection procedures. I would suggest the following wording or something similar: “The herd from which these pigs originated was inspected within the last 30 days. The weaned pigs referenced on the CVI were either resident in the herd at the time of the herd inspection or were born since the last inspection to dams which were resident in the herd at the time of the last visit and would thus have been inspected.”
As a reminder, this issue involves only pigs shipped outside an established production flow as defined in the Code of Federal Regulation. Pigs moving within a production flow or in compliance with an Interstate Movement Report are not affected by this interpretation. An Interstate Movement Report is an agreement between the state animal-health officials involved and the producer to allow for the routine movement of pigs within an established production flow. The shipment and record-keeping requirements are negotiated between the parties involved and normally allow for the ongoing shipment of pigs without the issuance of a CVI.
The AASV wishes to thank Dr Sam Holland, president of the National Assembly of State Animal Health Officials, and Dr John Clifford for their willingness to consider a resolution to this important issue.
Applicants sought for Alternate Student Delegate on AASV Board of Directors
The AASV Student Recruitment Committee is accepting applications for veterinary students interested in serving as the Alternate Student Delegate on the AASV Board of Directors. This student will represent student interests and serve as a non-voting member of the AASV board.
The alternate student delegate and student delegate are required to attend the AASV board’s two meetings each year: the spring meeting held during the AASV Annual Meeting, and the fall meeting, which is usually held in Kansas City each October. The student delegate presents a summary of board activities to the student membership at the student breakfast during the AASV Annual Meeting, and re-emphasizes all student opportunities in AASV to the AASV student members at that time. In addition, the delegate and alternate delegate are voting members of the AASV Student Recruitment Committee, and are invited to participate in committee conference calls and meetings. The delegates receive reimbursement to cover travel and lodging expenses for the fall board meeting and transportation expenses for the spring meeting.
Interested students must be members of AASV in their freshman, sophomore, or junior year. Applicants are required to submit the following documentation to the AASV (902 1st Avenue, Perry, IA 50220–1703; E-mail: email@example.com):
1. An introductory letter, not to exceed one page, explaining why they want to serve as the alternate student delegate for AASV, and their level of interest and background in swine medicine.
2. A one-page resume featuring the student’s interest and experience in production medicine, particularly swine medicine.
3. A statement of recommendation from the student’s AASV faculty advisor.
The deadline for submission of necessary documentation is January 31, 2009.
The delegate will be chosen by members of the AASV Student Recruitment Committee following review of the submitted materials. The Student Recruitment Committee may seek additional comment from other AASV members, including the AASV Collegiate Activities Committee.
The term of service is 2 years, beginning at the AASV Annual Meeting. During the first year, the student will serve as the alternate student delegate. The alternate delegate will automatically succeed as student delegate, beginning at the annual meeting the following year. The alternate delegate will serve in the capacity of delegate if the selected student delegate is unable to carry out his or her duties. Each year, a new alternate delegate will be selected by the AASV Student Recruitment Committee.