Do you want to voice your opinion to the Food and Drug Administration (FDA) on its role in protecting and promoting the public health? Do you have ties to a consumer group or community-based organization? Can you analyze scientific data?
If so, plan to attend a public meeting on April 30, 2010, to learn how you can bring the consumer perspective to FDA.
The meeting is being held for individuals and groups interested in nominating or serving as consumer representatives to FDA’s advisory committees and panels.
Advisory committees are made up of experts from outside the agency that FDA turns to for help on a range of scientific, technical, and policy issues including those associated with the evaluation of human and veterinary drugs, medical devices, foods, and other regulated products.
“Consumer representatives bring a valuable point of view to the difficult issues that face the agency,” says CDR Dornette Spell-LeSane, M.H.A., U.S. Public Health Service, deputy director of FDA’s Advisory Committee Oversight and Management Staff. “We serve the public and we want to involve them in our decision-making.”
“You don’t have to be a doctor, a scientist, or a health care professional to serve as a consumer representative,” adds Spell-LeSane. “But you do need a desire to advocate on behalf of the public and you should have strong ties to consumer or community-based organizations.”
Other criteria needed include the ability to
- analyze scientific data
- understand research design
- discuss benefits and risks of FDA-regulated products
- evaluate the safety and effectiveness of products under review
At the public meeting, you will learn about
- the role of the consumer representative on FDA advisory committees
- the process and criteria for nomination and selection
- functions of the different committees
- current committee vacancies
When: Friday, April 30, 2010, 8:15 a.m. to 4:30 p.m. ET
Where: FDA’s Center for Drug Evaluation and Research Advisory Committee Conference Room, Room 1066, 5630 Fishers Lane, Rockville, Md. Please use lower entrance, which faces Parklawn Drive.
How to register: Send an e-mail or fax to the contact person listed below no later than April 23, 2010. Provide complete information for each attendee including name, title, organization’s name, address, e-mail, and telephone and fax numbers. If you need special accommodations due to a disability, please notify the contact person at least 7 days in advance. Visitor badges will be held at the guard station. Participants will need a picture identification to pick up their badge.
Contact: Doreen Brandes, Office of the Commissioner, FDA
Before April 15, 2010:
After April 15, 2010:
Parking: Public parking is available on Fishers Lane across from the Parklawn Building at 5600 Fishers Lane (next to the building where the meeting will be held). Additional public parking is available at the Twinbrook Metro station located several blocks west of the meeting location. There is a charge at each of these parking lots. There is no public parking at the 5630 Fishers Lane location.
Metro: Take the Red Line to the Twinbrook Metro station. Walk east, cross Twinbrook Parkway, and walk one-half block on Fishers Lane to 5630 on the right.
More information: Additional background information will be available 5 days before the meeting and may be found at www.fda.gov/AdvisoryCommittees/ (look for link to Advisory Committee Public Meeting for Consumer Representatives).
This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.
Date Posted: April 2, 2010