Report on AMDUCA Satellite Teleconference; February 12, 1997
Format: Broadcast lasted 3 hours (1:00 - 4:00 PM Eastern time) and was comprised of an initial discussion of the provisions of AMDUCA between Dr. Stephen Sundlof (CVM Center Director) and Mr. Mark Barnett (CDRH moderator), Dr. Mary Beth Leininger (AVMA President) then joined the panel discussion.
Telephone and faxed-in questions were answered live on the air during the entire broadcast.
There was a half-hour break in the middle of the teleconference which was broadcast by satellite and accessible to the continental United States and Alaska.
Downlink sites: sites were available in more that 35 states, most states had multiple downlink sites. All FDA District Offices (except Chicago due to technical problems) had downlink sites. Several Extension Offices provided downlink sites as well as all U.S. Veterinary Medical Colleges except Tufts University.
Videotapes of the teleconference were made available by AVMA at a nominal cost.
Produced and broadcast by CDRH Tech Center
Cost to Center: $16,000 (including $4,000 for satellite time)
Overview:
This was the Center for Veterinary Medicine's first satellite teleconference. The Center partnered with the American Veterinary Medical Association (AVMA) and the FDA's Center for Devices and Radiological Health Tech Center (CDRH) to produce this teleconference. This conference was held to explain the extralabel use provisions of the Animal Medicinal Drug Use Clarification Act (AMDUCA) to veterinarians.
The enactment of AMDUCA, which became effective December 9, 1996, means that veterinarians now have more flexibility in the use of approved animal drugs in their practices. AMDUCA amended the Federal Food, Drug and Cosmetic Act to permit veterinarians to prescribe extralabel uses of approved human and animal drugs for their patients. AMDUCA imposes certain restrictions on veterinarians who prescribe extralabel uses of approved human and animal drugs, but most of these restrictions apply to the extralabel use of drugs in food-producing animals. The purpose of this teleconference was to explain to veterinarians their responsibilities under AMDUCA.
Agreement:
The mutual goals of CVM, AVMA and CDRH entering their letter of agreement were: to assure that the veterinary medical community and other interested parties were provided pertinent information necessary for the thorough understanding of CVM implementing regulations relating to AMDUCA; to give members of the veterinary medical community and other interested parties the opportunity to ask specific questions of the Center for Veterinary Medicine to ensure thorough understanding of AMDUCA by the veterinary medical community; and to ascertain from viewers the effectiveness of the program and to identify topics for inclusion in future teleconferences. (See Appendix A)
AVMA agreed to facilitate the establishment of specific downlink viewing locations for the teleconference by providing the potential viewers with information and/or assistance to aid them in receiving the broadcast; prepare and distribute promotional and publicity materials to inform the veterinary community of this event; collect viewer evaluations and provide them to CVM; duplicate and make available for distribution the video of the teleconference. AVMA also facilitated the downlinking of the program to academic institutions, particularly veterinary medical schools, and collaborated with other trade and professional organizations to distribute information about the teleconference and establish downlink sites. Additionally, AVMA shared a listing of known downlink sites with CVM. CVM posted this listing on its web site.
CVM selected the subject matter and speakers and prepared the script and accompanying materials for the broadcast, provided the funding for services and equipment to assure that the teleconference, as produced live by CDRH, was uplinked to a satellite for distribution to the continental United States. CVM also distributed information on the videoconference to its mailing list one month prior to the teleconference. The Center provided AVMA with copies of printed materials (the AMDUCA final regulations and the CVM Update) for further distribution to downlink sites.
CDRH agreed to produce and direct the live event and provided the signal for uplinking to the satellite. They also provided AVMA with a master videotape following the broadcast, as well as providing master videotapes and accompanying materials to the National Audiovisual Center for further distribution to interested individuals and organizations.
Development of the Broadcast Content:
The Center requested Iowa State University to videotape Dr. Sundlof's presentation "Implementation of Extralabel Drug Regulations: Food-Animal Veterinary Practice" presented at Iowa State University in November 15, 1996. The questions asked following this first presentation on AMDUCA served as a template for the development of the script. Additionally, all invitees were asked to solicit the membership of their organizations and submit as many questions as possible in advance of the teleconference. Over 80 questions were received prior to the teleconference. A Task Force composed of CVM staff from Office of New Animal Drug Evaluation, Office of Surveillance and Compliance and Office of Research was set up to provide responses to questions received in advance of the broadcast. These questions and answers were incorporated into the discussion between Dr. Sundlof, Dr. Leininger and Mark Barnett. Iowa State University also provided several video clips of "veterinarians in the field" posing questions about AMDUCA. These clips were interspersed throughout the broadcast for variety.
Experts in the Studio Audience:
These included not only representatives of all major practitioner and producer organizations (in most, organization presidents attended), but also the feed industry and FDA field and Headquarters (see Appendix B). Several of the CVM and FDA Field and Headquarters staff served as resources to respond to questions which were called or faxed in during the teleconference.
Invitations were sent in mid-December which allowed participants to plan ahead and obtain lower airfares; one major constraint appeared to be concern about this area's highly unpredictable weather in mid-February. Fortunately, there were no weather-related problems.
Promotion
CVM produced an Update, highlighted the teleconference on its Home Page and issued invitations for members of the studio audience. AVMA handled major promotion for this event by contacting all state veterinary associations. AVMA became aware that the message was not getting out as effectively as they would have liked; this resulted in additional contacts with regional and local veterinary associations. AVMA also featured the teleconference prominently on their Home Page and in the Journal of the American Veterinary Medical Association (JAVMA). Both CVM and AVMA websites were cross-linked as well as providing e-mail links to CVM and AVMA staff. CVM worked in conjunction with the Association of American Colleges of Veterinary Medicine to notify all veterinary schools in the United States. All veterinary schools in the U.S., except Tufts University, had a downlink available for their students. Several schools included the teleconference in the curriculum.
Results and Feedback
Tear-out postage-paid reply cards (Appendix C) were included in the JAVMA two weeks prior to the teleconference, approximately 250 of these cards were returned to AVMA (See Appendix D). A ten percent response rate is considered average. The fact that the cards were included in the JAVMA, but not readily available at the downlink sites (with notable exceptions) probably greatly decreased the number of cards returned. The exception was sites in Nebraska which required the cards to be submitted in order for attendees to receive continuing education credits. This was very effective.
Numerous state veterinary associations embraced the teleconference and included other activities such as follow-up discussions along with a lunch or dinner and, in some cases, site visits, as well as providing continuing education credits. These programs were also very effective in encouraging participation. Of the response cards received, an overwhelming number (93%) said they felt that the teleconference had increased their understanding of the FDA rules for extralabel use. Approximately 83% of those responding indicated that they traveled 0-25 miles to participate, some respondents noted they had traveled over 100 miles to participate in the teleconference. The vast majority of respondents (98%) indicated that they would be interested in participating in future teleconferences.
Follow-up activities
A total of over 120 questions (with some overlap) were received prior to and during the broadcast. In order to answer those questions submitted but not addressed in the teleconference, a series of four articles was published in JAVMA. Responses were prepared by the Center and published by AVMA. Additionally, AVMA worked with CVM and published a pamphlet on AMDUCA which was sent as an insert in JAVMA to all AVMA members. CVM and AVMA continue to distribute this pamphlet on request.
Recommendations
This satellite teleconference was a very effective tool for getting information out to a potentially very large audience simultaneously. Partnering with the affected industry, or in this case the American Veterinary Medical Association, proved to be a very efficient way to spread the word about how AMDUCA affects veterinarians. Working with organizations which represent those affected by the regulatory changes also demonstrates an endorsement by the organization to its constituents and increases the credibility of our message. The fact that we were able to address questions on the air as they are called in was also very well-received by our target audience. While we will never have an exact head-count of participants, the feed back we received has been overwhelmingly positive, with participants indicating they would welcome future teleconferences. For future teleconferences, response cards should be available at all downlink sites and as many as possible collected at the site, this would enable us to get a much more accurate estimate of numbers of participants.
Satellite teleconferencing is a very good way to get an identical message out to a large audience simultaneously, and is an excellent communications tool.
Appendices attached:
A. Letter of Agreement between American Veterinary Medical Association and the Food and Drug Administration's Center for Devices and Radiological Health and Center for Veterinary Medicine
B. Listing of studio audience participants
C. AMDUCA Satellite Teleconference Evaluation card
D. AMDUCA (Extralabel Drug Use) Satellite Teleconference Evaluation (provided by AVMA)
E. Promotional flyer produced at CVM for AMDUCA teleconference
Appendix A
LETTER OF AGREEMENT BETWEEN THE AMERICAN VETERINARY MEDICAL ASSOCIATION AND THE FOOD AND DRUG ADMINISTRATION'S CENTER FOR DEVICES AND ADIOLOGICAL HEALTH AND CENTER FOR VETERINARY MEDICINE
I. PURPOSE
This LETTER OF AGREEMENT identifies the specific responsibilities of the American Veterinary Medical Association (AVMA), and two components of the Food and Drug Administration [the Center for Veterinary Medicine (CVM) and the Center for Devices and Radiological Health (CDRH)] in a project to produce and distribute a live, satellite teleconference. The purpose of the project is to assure that relevant information related to the CVM implementing regulations for the Animal Medicinal Drug Use Clarification Act (AMDUCA) is provided to the veterinary medical community and other interested parties.
II. OBJECTIVES
The mutual goals of AVMA, CDRH, and CVM in entering into this agreement are:
To assure that the veterinary medical community and other interested parties are provided pertinent information necessary for the thorough understanding of CVM implementing regulations relating to AMDUCA.
To give members of the veterinary medical community and other interested parties the opportunity to ask specific questions of the Center for Veterinary Medicine to ensure thorough understanding of AMDUCA by the veterinary medical community.
To ascertain from viewers the effectiveness of the program and to identify topics for inclusion in future teleconferences.
III. SUBSTANCE OF AGREEMENT
A. The American Veterinary Medical Association, utilizing its own staff, contract personnel, or volunteers, and its own or donated funds, will:
1. Facilitate the establishment of specific downlink viewing locations for the teleconference by providing the potential viewers with information and/or assistance that will aid them in receiving the broadcast.
2. Provide master copies of all program-related print materials to persons and/or organizations wishing to view the broadcast.
3. Prepare and distribute promotional and publicity materials to inform the veterinary community about this event.
4. Collect viewer evaluations distributed at the downlink locations and provide them to CVM.
5. The AVMA is encouraged to facilitate the downlinking of this program at academic institutions, particularly veterinary medical schools, so that the faculty and students will be exposed to the discussions between FDA and the veterinary medical community. In order to broaden the base of support for this event, AVMA is encouraged to bring into collaboration other associations, both trade and professional, to assist in distribution of information about the teleconference, and/or to establish downlink sites, and/or to assist in evaluation of the program.
6. The AVMA will duplicate and make available for distribution the video of this teleconference upon request.
7. AVMA will assist CVM in assessing the impact and distribution of this teleconference by sharing information about dissemination of broadcast coordinates, and identification of the known downlink sites that were utilized.
B. The Center for Veterinary Medicine, utilizing its own staff and resources, will:
1. Select the subject matter and speakers for the broadcast and develop the script and accompanying material for the program.
2. Provide funding for equipment and services necessary to assure that the teleconference, as it is produced live by CDRH, is uplinked to a satellite for distribution throughout the continental United States. In order to provide the maximum viewing opportunities at downlink sites, the signal will not be encrypted.
3. Distribute information on the videoconference to CVM mailing list at least one month prior to the teleconference.
4. As soon the final regulations are published, CVM will provide AVMA with a copy of printed materials (AMDUCA final regulations and a CVM Update) for further distribution to downlink locations and others upon request.
C. The Center for Devices and Radiological Health, utilizing its own staff and resources, will:
1. Produce and direct the live event and provide a signal for uplinking to a satellite.
2. Provide AVMA with a master videotape following the broadcast.
3. Provide master videotapes and accompanying materials of the broadcast to the National Audiovisual Center for further distribution to interested individuals and organizations.
D. The purpose of this agreement is to foster collaboration and coordination between the American Veterinary Medical Association and the Food and Drug Administration. There will be no transfer of funds, equipment, or personnel; each organization will provide the financial support for its own activities; and there will be no obligation on the part of either organization to contribute financial support to the activities of the other.
IV. NAME AND ADDRESS OF PARTICIPATING PARTIES
A. American Veterinary Medical Association
1931 N. Meacham Road, Suite 100
Schaumburg, IL 60173-4360
B. Center for Devices and Radiological Health (HFZ-260)
16071 Industrial Drive
Gaithersburg, MD 20877
C. Center for Veterinary Medicine
7500 Standish Place
Rockville, MD 20855
V. Liaison officers
A. Dr. Bernadette Dunham
American Veterinary Medical Association
Assistant Director, Governmental Relations Division
1101 Vermont Ave., NW Suite 710
Washington, DC 20005-3521
Telephone (202) 789-0007 x 1611
FAX (202) 842-4360
E-mail 74232.57 @compuserve.com
B. Robert McCleary, Director
Division of Communication Media, OHIP
Center for Devices and Radiological Health (HFZ-260),
16071 Industrial Drive
Gaithersburg, MD 20877
Telephone (301) 827-3570
FAX (301) 827-0061
C. Joanne Kla
Communications Staff
Center for Veterinary Medicine
7500 Standish Place, HFV-12
Rockville, MD 20855
Telephone (301) 594-1771
FAX (301) 594-4512
E-mail jkla @bangate.fda.gov
After acceptance by all parties, this agreement will be effective from the date of the last signature until ( receipt by AVMA of the broadcast video tape from CVM). This agreement may be modified in writing by the consent of all parties. This agreement may be terminated by any party upon thirty (30) days advance written notice to the other parties.
APPROVED AND ACCEPTED FOR THE AMERICAN VETERINARY MEDICAL ASSOCIATION:
BY: s/Bruce W. Little, DVM
TITLE: Executive Vice President, American Veterinary Medical Association
DATE: _November 5, 1996
APPROVED AND ACCEPTED FOR THE CENTER FOR DEVICES AND RADIOLOGICAL HEALTH:
BY: s/Robert F. McCleary
TITLE: Acting Director, Division of Communication Media
DATE: Oct_ 28, 1996_
APPROVED AND ACCEPTED FOR THE CENTER FOR VETERINARY MEDICINE:
BY: s/ S. F. Sundlof_
TITLE: Director, Center for Veterinary Medicine
DATE: 10/25/96
Appendix B
Studio Audience Participants: AMDUCA Satellite Teleconference
Dr. Paul Sundberg
National Pork Producers CouncilDr. Bill Lance
American Association of Wildlife VeterinariansDr. Thomas Burkgren
American Association of Swine PractitionersDr. James Reid
Council on Veterinary Science-AVMADr. Don Sawyer
Council on Biologics and Therapeutic Agents-AVMADr. E. Curry-Galvin
AVMADr. Joe Gloyd
AVMADr. Robert Jorgenson
AVMADr. Deborah Kochevar
AVMA Congressional FellowDr. Richard Carnevale
Animal Health InstituteDr. Dennis Copeland
Animal Health Institute (Bayer)Dr. Rainer Muser
Animal Health Institute (Hoechst Roussel)Ms. Sondra Flick
Animal Health Institute (ALPHARMA)Ms. Sandra Phelan
Animal Health InstituteDr. M. Gatz Riddell
American Association of Bovine PractitionersDr. Everett Macomber
AVMADr. Dick Swanson
AVMADr. Frank Galey
Veterinary Toxicology UC-DavisMs. Tracy Raef
ElancoDr. Jim Riviere
FARADDr. Bonnie Buntain
USDA/FSISDr. Jim Stunkard
Veterinary PathologistDr. Ed Stephenson
Council on Biologics and Therapeutic Agents-AVMADr. Mike Apley
Iowa State UniversityMs. Sue Duran
Auburn University and VMACMr. Richard Sellers
American Feed Industry AssociationDr. G.A. Mitchell
CVMDr. Lynn Post
CVMDr. Linda Tollefson
CVMDr. Steve Vaughn
CVMDr. Michael Blackwell
CVMMs. Glo Dunnavan
CVMMr. Richard Geyer
CVMMr. Richard Arkin
CVMDr. Steven Solomon
FDA/ORAMr. Gary Dykstra
FDA/ORAHandling telephone and fax inquiries:
Dr. Douglass Oeller
Dr. Meg Oeller
Mr. Robert Guidos
CDRH Producers: Robert McCleary, Robert Fatula, and Barbara Richardson
Project Coordinators: Dr. Bernadette Dunham, AVMA and Joanne Kla, CVM
Appendix C
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Appendix D
AMDUCA (Extralabel Drug Use) Satellite Teleconference Evaluation
(Rev. 4/9/97)
| 1. The teleconference has increased my understanding of FDA rules for extralabel drug use. |
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| Where did you view the teleconference? |
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Community Hosp. - 1 Motorola - 25 St. Pete Jr. College - 1 Community College - 5 Univ. of Alaska - 1 National Guard - 1 Local Univ. - 10 Federal Office - 1 UNL-V&BS - 1 NE Res. Fac. - 2 School - 4 Community Center - 2 Prairie Winds Comm-1 Univ. Ctr GPVEC - 2 |
| How far did you travel to view the teleconference? |
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4. I would participate in other teleconferences sponsored by FDA CVM:
Yes 246 No 5
Suggested Topics:
Drug availability; adverse reaction problems & procedures
Veterinary Feed Directive (4)
CPG on non-therapeutic drug use
Drug Compounding, Violative Residues.
Herbals used for medicinal purposes. Phytochemicals: their current status w/CVM, FDA.
Drug Experience Reports (DER).
FDA/PBQA Residue Project.
USDA-FSIS-FDA tissue residue.
Wildlife Med - Two questions:
(1) Game species - stated must be an approved drug with known withdrawal prior to hunting season -what about extralabel use-must I use food animal drugs in opossums, deer, ducks, etc.?
2) Wildlife Rehab Ctrs are lay-people administration of drugs in extralabel manner all the drug use is.
Another session - same topic - I think lots of callers/faxers still had questions.
Compounding CPG's.
Aquaculture specific issues.
Untraditional species (fish).
Aquaculture drug use.
Changes in efficacy standards due to passage of Drug Availability Act.
Enforcement of extralabel drug use.
Prescription Feed Additives
Pharmacists understanding of VCPR
OTC filling Rx orders to supply producers.
Vaccine availability, why vaccines can be sold OTC.
VFD, Feline Sarcoma.
Vaccination guidelines for small animal patients. This is probably a USDA & AVMA issue.
Residue avoidance programs.
IRS - Cash accrual hassle.
Drug availability.
BSE (2) & regulations proposed. Risks, Status. Public Health.
Use & testing of drugs in horses that may end in food chain.
Practice
Animal Welfare
Veterinary liability issues
Specific sources of information on residues for extralabel drugs
Veal
60 follow-up of this subject
Specific dairy related drug topics
Disaster response
BST
Streamlining approval process of NADA's
Controlled drug record keeping & requirements
Medication use in minor species with information from other countries, i.e., Europe
Feed additive rules
Antidote availability
HACCP Program for individual livestock operations
FSIS Cooperative Activities
Food animal quality assurance
Veterinary Feed Directive/ADAA
Professional flexible labeling
Vaccines & withdrawals as to extralabel usage
Anything
Drug reactions from approved drugs
Quality assurance
Beef Quality assurance programs, new veterinary techniques, new equipment available. PRRS in swine
Policy Compliance
Similar - further more precise definition of the client patient relationship
Appendix E
The Food and Drug Administration/Center for Veterinary Medicine and the American Veterinary Medical Association announce a National Interactive Satellite Broadcast:
This national interactive broadcast via satellite is targeted to veterinary practitioners who have specific questions regarding the use and prescription of drugs in an extralabel manner. The final regulations implementing the Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA), were published in the FEDERAL REGISTER of Nov. 7, 1996; copies are available from the Communications Staff, FDA-CVM, 7500 Standish Pl., HFV-12, Rockville, MD 20855; phone (301) 594-1755; or on the FDA-CVM Web Site at http://www. cvm.fda.gov.
The program will feature a panel including CVM Director Dr. Stephen Sundlof and AVMA President Dr. Mary Beth Leininger, and an interactive studio audience, direct-to-the-studio telephone call-in or fax-in questions for response by the panel. This program will be broadcast free of charge.
The Satellite Coordinates are:
C-Band Satellite: Galaxy 9
Transponder: 22
Location: 123 degrees West longitude
Polarity: Horizontal
Downlink Frequency: 4140 MHz
Phone Numbers During Broadcast Hours ONLY
Q&A call in: (800) 527-1401 on Feb. 12, 1997
FAX: (888) 361-4011 on Feb. 12, 1997
Broadcast Trouble: (301) 827-3251 on Feb. 12, 1997
(at downlink sites)
Note: Any unforeseen changes regarding this broadcast will be posted immediately on the CVM's Internet Home Page and http://www.avma.org
Tune in via home satellite dish receiver or locate your nearest open downlink site by contacting either your State Veterinary Medical Association, your State Veterinary Medical College (where applicable), or your State U.S.D.A. Cooperative State Research, Education and Extension Service Veterinarian.
If you have specific questions regarding the AMDUCA regulations that you would like to have answered and wish to submit them in advance of the broadcast, please forward your question(s) to either:
| Dr. Bernadette Dunham, AVMA | Joanne M. Kla, FDA-CVM | |
| Phone:(800) 321-1473 x611 | Phone: (301) 594-1771 | |
| FAX: (202) 842-4360 | FAX: (301) 594-4512 | |
| E-mail: mailto:74232.57@compuserve.com |
E-mail:mailto:jkla@cvm.fda.gov |
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