FDAMA Southeast Stakeholders Meeting
Atlanta, April 28, 1999
Proceeding Summary
On April 28, 1999, the Southeast Regional Stakeholders Meeting entitled "Talking with
Stakeholders About Food and Drug Administration Modernization Act (FDAMA)" was held
at the U.S. Food and Drug Administration (FDA), 60 8th Street, N.E., Atlanta, Georgia. The
stakeholders meeting, in conjunction with a live national satellite teleconference with
FDA Commissioner Jane E. Henney, was held in eight local cities across the country.
Atlanta was the site for the FDA’s Office of Regulatory Affairs meeting.
Opening remarks by the Deputy Associate Commissioner for Regulatory Affairs included
the purpose of the Forum and an overview of the FDA. Participants were reminded that this
Forum was an ongoing discussion begun last summer with FDA Stakeholders that provided a
report on FDA’s progress in implementing FDAMA and the Agency’s strategic
direction in the future, and to seek stakeholders’ input in this process. The
Association of Food & Drug Officials (AFDO) and the Health Industry Manufactures
Association (HIMA) both made presentations after the teleconference. The Forum agenda
included two plenary sessions that addressed public participation and the
Commissioner’s five priorities: 1) Full and effective implementaiton of the FDAMA; 2)
Enhancing the Agency’s science base; 3) The safety of the Nation’s food supply;
4) The safety of the Nation’s blood supply; and 5) Reducing young people’s use
of tobacco products.
The Forum panel consisted of the Acting Deputy Associate Commissioner for Regulatory
Affairs, the Acting Regional Food and Drug Director for the Southeast Region, and the
Director of the Dallas District.
Participants interacted with each other in small workgroups prior to the teleconference
to develop questions. Several questions submitted were addressed via satellite. The
remaining questions were addressed by the Forum panel. Participants were assured that the
basic mission of the Agency is to get good products on the market and to get bad products
off the market -- that FDA is committed to making sure that there are good products on the
market at all times. Participants were also informed that FDA is very much interested in
conducting these kinds of meetings in the broadest possible coverage at different local
levels around the country.
Twenty-eight consumers were in attendance, representing industry, academia,
association, health care organizations, and federal, state and local government. All
attendees were provided information folders including background information about the
Agency and FDAMA.
[Official Recording for Docket No. 99N-0386, Donavan Reporting, 237 Roswell Street,
Marietta, GA 30060]
[Stakeholder questions reference: March 22, 1999, Federal Register notice]
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