Consumer Reps Join ODAC Meetings
ROCKVILLE, Md--In February, as part of an FDA pilot program, representatives of consumer groups sat at the table during an Oncologic Drugs Advisory Committee (ODAC) meeting. The ad hoc representatives from the Treatment Action Group, a New York organization representing people with AIDS, and the National Breast Cancer Coalition participated in the discussions of New Drug Applications but did not have a vote.
ROCKVILLE, Md--In February, as part of an FDA pilot program, representativesof consumer groups sat at the table during an Oncologic DrugsAdvisory Committee (ODAC) meeting. The ad hoc representativesfrom the Treatment Action Group, a New York organization representingpeople with AIDS, and the National Breast Cancer Coalition participatedin the discussions of New Drug Applications but did not have avote.
According to Randy Wykoff, MD, FDA associate commissioner forAIDS and special health issues, the pilot program is a responseto requests from cancer advocacy groups. Different representativeswill be chosen for each NDA that ODAC reviews. ODAC often asksnon-voting medical and /or scientific consultants to help reviewNDAs; consumer advocates would serve a simular function, Dr. Wykoffsaid.
