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ODAC Agenda Includes Comments, Data, Debate, Vote

ODAC Agenda Includes Comments, Data, Debate, Vote

ABSTRACT: This is part 2 of a two-part article that provides a behind the scenes look at the workings of the FDA Oncologic Drugs Advisory Committee. Part 1, which appeared last month, described the committees' duties and how members are selected. This article outlines a typical meeting and tells how the FDA uses the recommendations.

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 of AIDS."

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 disciplined researchers.

"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.

The Presentations

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.

The Debate

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 activism.

"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."

Current ODAC Members

Paul Bunn, MD, Chairman
University of Colorado Cancer Center

Adele S. Seifried, MS, Executive Secretary
Food and Drug Administration

Janice Dutcher, MD
Montefiore Medical Center, New York

Arlene Forastiere, MD
The Johns Hopkins Oncology Center

Richard Gelber, PhD
Dana-Farber Cancer Institute

James Ingle, MD
Mayo Medical School, Mayo Clinic

James Krook, MD
The Duluth Clinic Limited

Judith Ochs, MD
Arkansas Children's Hospital, Little Rock

Robert Ozols, MD, PhD
Fox Chase Cancer Center, Philadelphia

Albert Siu, MD, Consumer Rep
Mt. Sinai Medical Center, New York

Sandra Swain, MD
Salick Health Care Inc., Bethesda, Maryland

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