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Consumer representatives needed

for the Cellular, Tissue and Gene Therapies Advisory Committee
of the U.S. FDA

 

The Food & Drug Administration (FDA) is accepting nominations for Consumer Representatives to the FDA's Cellular, Tissue and Gene Therapies Advisory Committee.  

 

Advisory committees are very important to the FDA because they review controversial scientific issues and provide advice to the agency on whether to approve a drug, and if so any restrictions on distribution or labeling the agency should require. Most members of advisory committees are medical and scientific experts, but one member must represent the patient community. 

 

Since expert scientists are often involved in clinical trials, the FDA finds it difficult to locate physicians without any conflict-of-interest to serve on advisory committees. Congress now requires that all conflicts-of-interest by committee members must be revealed before each meeting.

 

The Patient Representative is extremely important to all advisory committees because they speak on behalf of the patient community, and often approach questions with a practical viewpoint: e.g., should patients receive a patient information brochure with this medication so they will be aware of side effects, etc. If you or a colleague are interested in serving on the advisory committee, please go the FDA Website listed below and submit the requested information directly to the FDA. 

 

Below is a link to the FDA website that describes the needed qualifications.

 

http://www.fda.gov/oc/advisory/consumer.html

 Abbey S. Meyers, President, National Organization for Rare Disorders
Joyce W. Graff, Executive Director, VHL Family Alliance