Food and Drug Administration Modernization Act of 1997 (FDAMA)
REPORT ON THE CENTER FOR VETERINARY MEDICINE
STAKEHOLDERS MEETING
AUGUST 19, 1998
Introduction
All of the Centers within the Food and Drug Administration have held public meetings with their key constituent groups to ask how the Centers can best meet their statutory obligations under the Federal Food Drug and Cosmetic Act. The funds and staffing available to the FDA and its Centers fall short of what is needed to complete all the tasks assigned under current law.
Therefore, FDA and the Centers have called on their constituents, or "Stakeholders," for suggestions and a plan about how the Centers should complete their missions. The information from the meetings will go into a report to Congress, as required under the Food and Drug Administration Modernization Act (FDAMA) that went into law last year.
The Meeting’s Structure
CVM held its Stakeholders meeting August 19, 1998, from 9:00 a.m. to 4:30 p.m., at the Hubert H. Humphrey Building, Washington, D.C.
Total attendance at CVM’s meeting was 85 people.
A total of 15 groups made presentations at the meeting. Five speakers were assigned to each of three panels. The first panel included representatives of veterinary practitioner groups, animal health industry associations, and a consumer group. The second panel included animal producer groups. The third included grain and feed associations and animal science organizations.
Each panel was matched with a panel made up of CVM officials. Each speaker had up to 10 minutes to deliver prepared remarks, and then the officials on the CVM panel had five minutes to ask clarifying questions about the presentations.
Besides speaking from the panels, several industry and consumer group representatives spoke from the floor.
Issues
An issue brought up by many of the groups, including drug manufacturers, livestock producers, and feed producers, was full implementation of the Animal Drug Availability Act (ADAA). All of the speakers who mentioned it strongly urged CVM to devote whatever resources necessary to fully implement ADAA. Some speakers objected to CVM’s interpretation of parts of the ADAA.
Several commented that CVM should use its mission statement as its guide to setting priorities.
Several groups said animal drug approvals should be a top priority. Some groups recommended that CVM to devote more resources to approving new animal drugs, even to the extent of reducing efforts in other areas.
Several groups also urged CVM to increase its compliance efforts to monitor the marketplace to remove unapproved products, including those that can cause food safety or animal health concerns, but also those that provide unfair competition in the marketplace.
Some groups said CVM must take strong actions to prevent any adverse consequences to the public health stemming from the use of antimicrobial drugs in veterinary medicine.
The possibility of user fees was rejected by all who mentioned them.
Nearly all of the presenters said CVM must continue to keep science at the heart of all of its decisions.
Several groups suggested that CVM "partner" with other federal agencies. Specifically, they indicated that CVM could work with the U.S. Department of Agriculture’s Agriculture Research Service and the Cooperative State Research, Education and Extension Service to conduct research and communicate with outside groups.
In addition, many groups offered to assist CVM’s effort in disseming information through their organiations’ communications channels.
Most groups also encouraged CVM to pursue international activities, such as the harmonization of pre-approval drug requirements and international trade standards.
Several groups expressed the view that there should be better coordination among FDA field personnel who represent CVM, so that there would be more consistencies, especially concerning inspections. There should also be better coordination between CVM headquarters and field personnel, they added.
Next Steps
All of the recommendations made during the CVM Stakeholders meeting will be analyzed. A transcript of the meeting will be placed on FDA’s Website.
CVM officials will also review written Stakeholder comments submitted as part of the record. Comments should be submitted to Docket Number 98N-0339V by September 11.
After they have reviewed all the information, CVM officials will prepare a report with recommendations on how the Center plans to pursue its mission with the limited resources available to it. FDA will merge CVM’s report with similar reports from the other Centers to develop recommendations that will be presented in a report to Congress by November 21, as required under FDAMA
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