FDA secures full industry engagement on antimicrobial resistance strategy

The US Food and Drug Administration (FDA) has announced the first of its progress reports on its strategy to promote the judicious use of antimicrobials in food-producing animals. All 26 drug manufacturers affected by Guidance for Industry (GFI) #213 have now agreed to fully engage in the strategy by phasing out the use of medically important antimicrobials in food-producing animals for food-production purposes and phasing in the oversight of a veterinarian for the remaining therapeutic uses of such drugs. While GFI #213 specified a 3-year timeframe (until December 2016) for drug sponsors to complete the recommended changes to their antimicrobial products, some sponsors have already begun to implement them.

The FDA is committed to updating the public on the progress that drug sponsors have made in aligning their products with GFI #213 and intends to do so on a 6-month basis. The FDA’s progress reports will summarize current and pending actions taken by sponsors to align with the guidance, including the type of action (eg, withdrawal, change in marketing status) and, when possible, without revealing confidential business information (CBI), the type of animal for which the drug is approved for use, and the type of application (pioneer, generic, combination).

As of June 30, 2014, FDA reports the following progress in the animal-health industry’s engagement in GFI #213:

The last sponsor, Pharmaq AS, has agreed in writing to engage in the judicious use strategy and has consented to allow FDA to publicly acknowledge its participation. With this addition, all 26 sponsors of 283 affected applications have now confirmed in writing their intent to engage with FDA as defined in GFI #213 and have given FDA consent to identify them as participants. Please see FDA’s March 26, 2014 update for a list of companies that had previously committed to the strategy (http://www.fda.gov/AnimalVeterinary/SafetyHealth/AntimicrobialResistance/JudiciousUseofAntimicrobials/ucm390738.htm).

There have been two published label changes, one to withdraw a production claim and one to change a product’s marketing status from over-the-counter to available by prescription only. These changes are documented in the online chart of Applications Affected by GFI #213 (http://www.fda.gov/AnimalVeterinary/SafetyHealth/AntimicrobialResistance/JudiciousUseofAntimicrobials/ucm390429.htm), and FDA will continue to update this chart in real time when label changes are approved.

One additional drug label change is currently pending. The change is from over-the-counter marketing status to prescription status. More details about the product and the change in labeling will be available after the paperwork is complete. The level of summary detail provided in this update for pending supplemental applications is limited by the need to protect CBI. To avoid revealing CBI, either directly or indirectly, the level of summary detail provided for future updates regarding GFI #213-related pending actions may change as this voluntary initiative progresses and the pool of affected applications gets smaller. Given the small number of pending and completed changes at this time, FDA cannot provide more information about the type of drug being affected (eg, application type, species, indication) in this update without revealing protected information.

Thirty-one approvals for affected products have been withdrawn to date, and there are no drug approval withdrawals currently pending. After an approval is voluntarily withdrawn, that product can no longer be marketed or sold in the United States.

The FDA will continue to work with the animal pharmaceutical industry, animal producers, and the veterinary community to address antimicrobial resistance and preserve the effectiveness of antimicrobials of human health importance.

Mandatory reporting of novel coronaviruses in swine

Secretary of Agriculture Tom Vilsack issued a federal order on June 5 requiring producers, veterinarians, and diagnostic laboratories to report presumptive or confirmed positive occurrences of porcine epidemic diarrhea virus (PEDV), porcine deltacoronavirus (PDCoV), or other novel swine enteric coronaviruses that meet the case definition (http://www.aphis.usda.gov/animal_health/animal_dis_spec/swine/downloads/secd_case_definition.pdf). An occurrence may be the initial detection of disease or a reoccurrence of previously detected disease. If a sample is submitted to a National Animal Health Laboratory Network (NAHLN) laboratory for testing and is found positive, duplicate reporting by the herd owner, producers, veterinarians, and others with knowledge of the disease is not required. Reporting must be directed to the State Animal Health Official or the Animal and Plant Health Inspection Services (APHIS) Assistant District Director (previously referred to as the Area Veterinarian in Charge) located in the state in which the herd resides.

The following specific reporting information must be submitted:

•  Premises identification number (PIN) or an alternative premises location identifier;

•  Date of sample collection;

•  Type of unit being sampled (eg, sow, nursery, finisher);

•  Test methods used to make the diagnosis; and

•  Diagnostic test results.

In addition, the producer must develop and implement, in collaboration with the accredited herd veterinarian, state veterinarian, or APHIS veterinarian, a herd management plan that addresses the following:

•  Biosecurity of visitors and vehicles entering or exiting the premises;

•  Monitoring employee biosecurity;

•  Periodic herd-health observation;

•  Animal movement (both into and out of the herd);

•  Cleaning and disinfection of facilities;

•  Diagnostic testing to monitor the status of the herd infection and assess efficacy of control strategies; and

•  Maintenance of records on pig movement that are accessible to state or federal animal-health officials upon request.

Herd owners or veterinarians failing to promptly report a presumptive or confirmed positive case or to follow a herd management plan may be subject to civil penalties or revocation of veterinary accreditation, and additional requirements (hold order, quarantine, permitting, or other restrictions on movement of pigs) may be placed on their premises by state or federal animal-health officials.

The actual federal order and additional supporting documents can be found on the United States Department of Agriculture Web site (http://www.aphis.usda.gov/animal-health/secd). Additional information can be viewed on the AASV PEDV web page (http://www.aasv.org/ aasv%20website/Resources/Diseases/PorcineEpidemicDiarrhea.php).

Call for papers – AASV 2015 Student Seminar

Veterinary Student Scholarships

The American Association of Swine Veterinarians announces an opportunity for veterinary students to make a scientific presentation during the Student Seminar at the AASV Annual Meeting in Orlando, Florida, on Sunday, March 1, 2015. Interested students are invited to submit a one-page abstract of a research paper, clinical case study, or literature review for consideration. The submitting student must be a current (2014-2015) student member of the AASV at the time of submission, and must not have graduated from veterinary school prior to March 1, 2015. Submissions are limited to one (1) abstract per student.

Abstracts and supplementary materials must be received by Dr Alex Ramirez (alex@aasv.org) by 11:59 pm Central Daylight Time on Monday, September 22, 2014 (firm deadline). All material must be submitted electronically. Late abstracts will not be considered. You should receive an e-mail confirming the receipt of your submission. If you do not receive this confirmation e-mail, you must contact Dr Alex Ramirez (alex@aasv.org) by Wednesday, September 24, 2014, with supporting evidence that the submission was made in time; otherwise, your submission will not be considered for judging. The abstracts will be reviewed by an unbiased, professional panel consisting of a private practitioner, an academician, and an industry veterinarian. Fifteen abstracts will be selected for oral presentation in the Student Seminar at the AASV Annual Meeting. Students whose papers are selected will be notified by October 15, 2014, and will be expected to provide the complete paper or abstract, reformatted for publication, by November 17, 2014.

To help defray the costs of attending the AASV meeting, Zoetis provides a $750 honorarium to the student presenter of each paper selected for oral presentation during the Student Seminar.

Each veterinary student whose paper is selected for oral presentation also competes for one of several veterinary student scholarships awarded through the AASV Foundation. The oral presentations will be judged to determine the amount of the scholarship awarded. Zoetis funds a $5000 scholarship for the student whose paper, oral presentation, and supporting information are judged best overall. Elanco Animal Health provides $20,000 in additional funding, enabling the AASV Foundation to award $2500 each for 2nd through 5th place, $1500 each for 6th through 10th place, and $500 each for 11th through 15th place.

Abstracts that are not selected for oral presentation in the Student Seminar will be considered for participation in a poster session at the annual meeting. Zoetis and the AASV fund a stipend of $250 for each student who is selected and participates in the poster presentation. In addition, the presenters of the top 15 poster abstracts compete for awards ranging from $200 to $500 in the Veterinary Student Poster Competition.

Complete information for preparing and submitting abstracts is available on the AASV Web site at www.aasv.org/annmtg/2015/studentseminar.htm. Please note: the rules for submission should be followed carefully. For more information, contact the AASV office (Tel: 515-465-5255; Fax: 515-465-3832; E-mail: aasv@aasv.org).

Nominate exceptional colleagues for AASV awards

Do you know an AASV member whose dedication to the association and the swine industry is worthy of recognition? The AASV Awards Committee requests nominations for the following five awards to be presented at the upcoming AASV annual meeting in Orlando.

Howard Dunne Memorial Award – Given annually to an AASV member who has made a significant contribution and rendered outstanding service to the AASV and the swine industry.

Meritorious Service Award – Given annually to an individual who has consistently given time and effort to the association in the area of service to the AASV members, AASV officers, and the AASV staff.

Swine Practitioner of the Year – Given annually to the swine practitioner (AASV member) who has demonstrated an unusual degree of proficiency in the delivery of veterinary service to his or her clients.

Technical Services / Allied Industry Veterinarian of the Year – Given annually to the technical services or allied industry veterinarian who has demonstrated an unusual degree of proficiency and effectiveness in the delivery of veterinary service to his or her company and its clients as well as given tirelessly in service to the AASV and the swine industry.

Young Swine Veterinarian of the Year – Given annually to a swine veterinarian who is an AASV member, 5 years or less post graduation, who has demonstrated the ideals of exemplary service and proficiency early in his or her career.

Nominations are due December 15. The nomination letter should specify the award and cite the qualifications of the candidate for the award. Submit to: AASV, 830 26th Street, Perry, IA 50220-2328; Fax: 515-465-3832; E-mail: aasv@aasv.org.

Call for submissions – Industrial Partners

The American Association of Swine Veterinarians invites submissions for the Industrial Partners portion of the 46th AASV Annual Meeting, to be held February 28-March 3, 2015, in Orlando, Florida. This is an opportunity for commercial companies to make brief presentations of a technical, educational nature to members of the AASV.

As in the past, the oral sessions will consist of a series of 15-minute presentations scheduled from 1:00 to 5:00 pm on Sunday, March 1. A poster session will take place on the same day. Poster authors will be required to be stationed with their posters from 12:00 noon until 1:00 pm, and the posters will remain on display throughout the afternoon and the following day for viewing by meeting attendees.

Restricted program space necessitates a limit on the number of presentations per company. Companies that are members of the Journal of Swine Health and Production Industry Support Council (listed on the back cover of each issue of the journal) may submit two topics for oral presentation. Sponsors of the AASV e-Letter may submit an additional topic for oral presentation. All other companies may submit one topic for oral presentation. Each company may also submit one topic for poster presentation (poster topics may not duplicate oral presentations). All topics must represent information not previously presented at the AASV Annual Meeting or published in the meeting proceedings.

Topic titles, a brief description of the presentation content, and presenter information (name, address, telephone and fax numbers, e-mail address) must be received in the AASV office by October 1, 2014. Please identify whether the submission is intended for oral or poster presentation. Send submissions via mail, fax, or e-mail to Commercial Sessions, AASV 830 26th Street, Perry, IA 50220-2328 Fax: 515-465-3832 E-mail: aasv@aasv.org.

Authors will be notified of their acceptance by October 15, 2014, and must submit the paper for publication in the meeting proceedings by November 17, 2014. All presentations – oral and poster – will be published in the proceedings of the meeting. Papers for poster presentations are limited to one page of text plus one table or figure. Papers for oral presentations may be up to five pages in length (including tables and figures), when formatted according to the guidelines provided to authors upon acceptance of their presentations. Companies failing to submit papers in a timely manner will not be eligible for future participation in these sessions.