Take a Behind the Scenes Look at ODAC

This two-part article provides a behind the scenes look atthe workings of the FDA Oncologic Drugs Advisory Committee (ODAC),based on interviews by Washington Bureau Chief Margot Fromer withthe ODAC administrator, current chairman, and immediate past chairman.Part 1 describes ODAC's duties and how members are selected. Part2, to appear next month, outlines a typical meeting and tellshow 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'smain function is to offer scientific and technical advice to theFDA," Adele Seifried, MS, ODAC administrator, told OncologyNews International in an interview.

Ms. Seifried said that all of the FDA's advisory committees servea secondary but highly important purpose: to let the public seewhat's going on. "It's good for consumers, as well as fordoctors and nurses, to have an understanding of how the FDA works,how thoroughly it investigates new drug applications, and howseriously the members of ODAC perceive their role as advisorsto the agency."

The FDA has a full complement of scientists who evaluate all aspectsof a new drug or device, but outside specialists offer a broadrange of perspectives, practical and empirical medical judgment,and years of field experience.

ODAC presents its advice and findings to the FDA Division of OncologicDrug Products, but it is Robert Temple, MD, director of the Officeof 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 thanever of what cancer treatment and oncologic drugs are all about.

"Even after I've read all the data that the drug companyhas gotten together, I sometimes change my mind about a new drugafter I've heard their presentation and asked them questions,"he said.

"I listen to the FDA people too, and take into account theirinteractions with the sponsoring company," Dr. Bunn added."That sometimes makes me think differently about a drug."

Charles A. Schiffer, MD, professor of medicine and oncology, Universityof Maryland Cancer Center, and immediate past chairman of ODAC,told Oncology News International that "not only did I learnan enormous amount about FDA and the difficulty of the drug approvalprocess, but now I have a greater understanding of the subtletiesof clinical trials--which I hope will make me a better clinicalinvestigator."

He also said he was pleased to see the approval of so many newoncologic drugs during his tenure on the committee.

Contrary to what many people believe about the FDA, its purposeis not to keep drugs away from the public, Dr. Schiffer said."In fact, during the 4 years that I was an ODAC member, Ifelt as if the agency and our committee were straining towardapproval whenever possible. I believe that FDA has tremendousmotivation to approve good compounds and that it bends over backwardto find favorable aspects of new drug applications."

Recruiting Members

ODAC was established September 1, 1978, and is regulated by theFederal Advisory Committee Act of 1972. Most members of drug advisorycommittees, including ODAC, are physicians who specialize in thedisease(s) for which the drugs are intended. Members also maybe nurses, statisticians, and epidemiologists.

A consumer-nominated member, one of whom serves on all committees,has full voting privileges and must possess enough scientificexpertise to participate fully in ODAC deliberations. He or shemust have worked closely with consumer groups and, in fact, isusually recommended by a consortium of such groups.

"Recruiting committee members is more complicated than you'dthink," Ms. Seifried said. "We have to make certainthat we have balance and diversity. We need people from differentparts of the country with expertise in different types of cancer,and women and minorities."

'Reams of Paperwork'

Although each committee member serves for 4 years, their termsoverlap, and sometimes members leave the committee before theirterm has expired.

"That means we have to keep an ongoing list of potentialcandidates," Ms. Seifried said, "people who are willingto do the reams of paperwork required and to work very hard fourtimes a year before and during each ODAC meeting for practicallyno money [$150 a day plus travel expenses]."

"It's a lot of work," Dr. Bunn said, "but it'sinteresting, and I've been glad to do it. I wish more membersof the public--and especially more physicians--knew how ODAC works."

In addition, members often meet in private with the FDA Divisionof Oncol-ogic Drug Products, as well as representatives of pharmaceuticalcompanies, to discuss the kinds of studies needed to best evaluatedrugs in the company's developmental pipeline--and to give companiesthe best possible chance of approval when a drug is presentedto ODAC.

Ms. Seifried recruits from professional societies, academic institutions,government agencies, industry and trade associations, and consumerand patient groups. A request for candidates also appears oncea year in the Federal Register.

"People contact us all the time to say that they're interestedin serving on ODAC or they know someone who would be a good candidate,"she said. If a candidate sounds as if he or she would be a goodfit for ODAC, Ms. Seifried conducts a telephone interview, andher staff does a background check.

"If everything is okay, and they're still interested, wesend them a packet of information and all the forms they haveto fill out [professional background, medical expertise, participationin clinical trials, and past and present financial or other relationshipswith drug companies]."

The name is then submitted to the Division of Oncologic Drug Products,Ms. Seifried said. The FDA, not ODAC, appoints ODAC members.

Avoiding Conflicts of Interest

The FDA is particularly concerned about financial conflicts ofinterest--or the appearance of such a conflict. When a new drugcomes up for discussion, each committee member is asked if heor she has ever had a financial relationship with the sponsoringcompany, especially participation in its clinical trials.

Dr. Bunn said that the FDA devotes much time and money to ferretingout conflicts of interest. "It's a nuisance to fill out allthose forms," he said, "but it's important for the publicto be assured that the people who have a big say in approvingdrugs have not received any compensation from the companies whowill profit from them."

Since it is almost impossible to find oncologists who are knowledgeableabout the process of clinical research but who have never investigatedanticancer drugs, FDA rules do not prohibit ODAC members fromparticipating in committee deliberations about drugs from companiesthey have worked with, or even from voting on recommendationsfor approval. But that information must be made part of the publicrecord.

"As director of a university cancer center where we treatabout 3,000 patients a year, I've had dealings with practicallyevery company that develops oncologic drugs," Dr. Bunn said."But if I'm up front about it, it's not a problem."