This two-part article provides a behind the scenes look at
the workings of the FDA Oncologic Drugs Advisory Committee (ODAC),
based on interviews by Washington Bureau Chief Margot Fromer with
the ODAC administrator, current chairman, and immediate past chairman.
Part 1 describes ODAC's duties and how members are selected. Part
2, to appear next month, outlines a typical meeting and tells
how FDA uses ODAC's recommendations.
WASHINGTON--The 11 member Oncologic Drugs Advisory Committee (ODAC)
is one of 17 such committees that advise the Food and Drug Administration
(FDA) about drug safety and effectiveness. "The committee's
main function is to offer scientific and technical advice to the
FDA," Adele Seifried, MS, ODAC administrator, told Oncology
News International in an interview.
Ms. Seifried said that all of the FDA's advisory committees serve
a secondary but highly important purpose: to let the public see
what's going on. "It's good for consumers, as well as for
doctors and nurses, to have an understanding of how the FDA works,
how thoroughly it investigates new drug applications, and how
seriously the members of ODAC perceive their role as advisors
to the agency."
The FDA has a full complement of scientists who evaluate all aspects
of a new drug or device, but outside specialists offer a broad
range of perspectives, practical and empirical medical judgment,
and years of field experience.
ODAC presents its advice and findings to the FDA Division of Oncologic
Drug Products, but it is Robert Temple, MD, director of the Office
of New Drug Evaluation who actually approves a drug for marketing.
Paul Bunn, MD, director of the University of Colorado Cancer Center,
has been a member of ODAC for 3 years and is its new chairman.
He said in an interview that ODAC has made him more aware than
ever of what cancer treatment and oncologic drugs are all about.
"Even after I've read all the data that the drug company
has gotten together, I sometimes change my mind about a new drug
after I've heard their presentation and asked them questions,"