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.
According to Randy Wykoff, MD, FDA associate commissioner for AIDS and special health issues, the pilot program is a response to requests from cancer advocacy groups. Different representatives will be chosen for each NDA that ODAC reviews. ODAC often asks non-voting medical and /or scientific consultants to help review NDAs; consumer advocates would serve a simular function, Dr. Wykoff said.