By Margot Fromer
WASHINGTON-The 11 member Oncologic Drugs Advisory Committee (ODAC)
was established in 1978 to offer scientific and technical advice
to the FDA about the safety and effectiveness of cancer drugs,
including new drugs and new indications for already approved agents,
Adele Seifried, MS, ODAC administrator, told ONCOLOGY NEWS INTERNATIONAL.
Except in rare circumstances, all ODAC meetings, which take place
at FDA headquarters in Rockville, Md, are open to the public.
They are announced in the Federal Register at least 2 weeks in
advance. A meeting usually lasts 2 days during which two to four
new drug applications are considered.
The FDA sets an agenda for each meeting and prepares a set of
questions for the committee's consideration.
Time for Public Comments
An hour is set aside at the beginning of each meeting so that
members of the public can make comments in person or have letters
read into the record.
"This is an extremely important part of the process,"
said Paul Bunn, MD, a 3-year member of ODAC and its new chairman.
"Also, because the meetings are open, drug companies can
see how they are run and how ODAC works," added Dr. Bunn,
director of the University of Colorado Cancer Center. "I
think the quality of the sponsors' presentations has improved
because of this," he said.
Charles A. Schiffer, MD, ODAC's immediate past chairman, also
likes open meetings and the opportunity for public comment. "Take
AIDS for example. In the beginning, activists were clamoring for
new treatments. They didn't care how bad the side effects were
because they felt that nothing could be worse than the onslaught
But as time went on, he said, the activists learned how drugs
are tested and approved, and they began to realize how important
it is in the long run to have good studies done by reliable and
"The people concerned about AIDS who came to our meetings
rapidly learned some of the ins and outs of pharmaceutical research
and could then serve as informed and responsible advocates for
their constituents," said Dr. Schiffer, professor of medicine
and oncology, University of Maryland Cancer Center.
After public comments, the new drug's sponsor is given time to
make its presentation. An FDA medical reviewer then summarizes
the agency's evaluation of the sponsor data (the culmination of
many months of work prior to the ODAC meeting). The FDA then asks
ODAC for its advice about safety and efficacy, labeling and special
warnings, and additional studies needed.
After fortifying themselves with coffee and snacks, ODAC members
buckle down to serious discussion. They ask questions of both
the FDA medical reviewer and the drug's sponsor, and they debate
with one another.
This is the part that ODAC members seem to enjoy most. Dr. Schiffer
described it as "intellectual fun." He said that the
committee wants to maintain a collegial atmosphere with both the
FDA reviewer and the drug company representatives.
"For a very few drugs, the decision on approval is easy,"
he said. "If there's a striking new compound that obviously
cures people, it's going to be approved. But most new drugs fall
into a gray area."
He noted that in these cases, both the FDA and ODAC try to be
liberal. "If it looks like it's going to have a dramatic
long-term benefit in even a small percentage of patients with
an otherwise untreatable disease, and if the side effects are
tolerable, we often recommend approval," he said.
During the final discussions, interpretations of data are discussed,
and the ultimate issues of safety and efficacy are weighed. When
all members have had their say, when all questions have been answered,
a vote is taken.
What the Vote Means
A vote in favor of approval means only that ODAC, a committee
of private individuals, recommends that FDA take action. "It
takes a few months for the agency to officially give its stamp
of approval," Ms. Seifried said.
The Division of Oncologic Drug Products reviews the committee's
discussion (which is both audio- and videotaped), especially if
the vote was close or tied. Chemical and manufacturing issues
must also be ironed out with the sponsor.
"The division takes our advice very seriously, but it is
not obligated to do what the committee recommends," she noted.
Dr. Bunn was asked if he ever feels frustrated if the FDA does
not follow ODAC's recommendations on approval.
"Not really," he replied. "First of all, it's the
law and we all understand that. Second, now that we have accelerated
approval, things aren't as black and white as they used to be.
We can recommend approval with some caveats [further clinical
trials or more or different data on studies already completed],
and that seems to work well."
He spoke positively about accelerated approval, which has been
used more frequently in the past decade as a result of consumer
"It's reasonable to try new things," Dr. Bunn said.
"Time will tell if accelerated approval works well in the
long run. I think that if a drug is safe and has some positive
effect but more clinical work still needs to be done, I say give
it a try."