AIDS TREATMENT NEWS #188, December 3, 1993
John S. James

The new panel, the National Task Force on AIDS Drug Development, will be chaired by Dr. Philip Lee, Assistant Secretary for Health, and will consist of 15 members. The other 14 have not yet been chosen, and the public can make nominations through the month of December.

Participants in the November 30 press conference which announced the Task Force included: Secretary Shalala; Assistant Secretary Lee; Dr. David Kessler, Commissioner, Food and Drug Administration; Dr. Harold Varmus, Director, National Institutes of Health; Dr. P. Roy Vagelos, Chairman and CEO, Merck & Company, Inc.; Dr. Edward Scolnick, President, Merck Research Laboratories; Dr. Anthony Fauci, Director, Office of AIDS Research, National Institutes of Health; Ms. Kristine Gebbie, National AIDS Policy Coordinator; Mr. Moises Agosto, National Minority AIDS Council; Mr. Derek Hodel, AIDS Action Council; and Mr. Victor Zonana, Deputy Assistant Secretary for Public Affairs, HHS.

The Task Force will be administered by the Office of AIDS and Special Health Issues of the U.S. Food and Drug Administration. Dr. Randy Wykoff, the director of that office, told AIDS TREATMENT NEWS how this panel differs from other groups in the past:

"One, this Task Force is highly focused, on drug development; it is not a broad mandate on AIDS. Second, it will be the first process of this type that will make recommendations to the HHS Secretary, who has the authority and ability to implement them. Third, this will be the first time that we have this kind of commitment with everyone at the table; industry buys in, we have community support, and all aspects of government are there. The Task Force can make recommendations that will make a difference.

"One reason for keeping the Task Force small is to make sure that the people on it are the true decision makers, who know the issue and can implement decisions. None of us want to have another process of simply making recommendations.

"This Task Force will direct its efforts in two ways. One is toward any roadblocks that currently exist, either in perception or reality, that if removed would improve the likelihood of bringing good products into clinical trials and ultimately into clinical practice.

"The task force will also ask if there are any good creative ideas that should be tried at this point. Without criticizing what has been done in the past, it is legitimate to say that it's almost 1994 and we still do not have highly effective agents. Is there anything different that we should try -- such as new approaches to screening products, new approaches to sharing information, or different approaches to toxicology, or clinical trial design, or regulatory processes? It will be useful to have a high-level body, one that can implement recommendations, look and decide where to go ahead."

Shalala, Lee Statements

The following sections from the statements of HHS Secretary Shalala, and Assistant Secretary (and Task Force chairman) Lee, provide background on the Task Force and the approach it is expected to take:

Dr. Shalala: "The National Task Force on AIDS Drug Development, which I am announcing today, has a clear and critical mission: to identify, and remove, any barriers or obstacles to developing effective treatment. It will make certain that all possible productive avenues are pursued with vigor.

"The members of the task force will be drawn from government, the pharmaceutical industry, academia, medicine, and the AIDS- affected communities.

"This represents an unprecedented high-level collaboration among leaders in the field. . . .

"But the sad fact today is that not a single New Drug Application for an antiretroviral agent awaits FDA approval.

"No matter how much we shorten the pipeline, we cannot achieve our goal unless we start filling that pipeline with promising compounds. That is the purpose of the new panel."

Dr. Lee: "To continually evaluate strategies and tactics and to build consensus, collaboration is required. Full participation is needed between government agencies, industry, the medical community, academia, and individuals who are HIV infected, as well as those affected by the epidemic. Too often in the past, needed links have been missing or relationships have been adversarial, resulting in unnecessary duplication of efforts or potential drugs not being developed and evaluated as rapidly as they might, or utilized most effectively.

"While working to remove the barriers, the Task Force will not scrap innovative and creative approaches used in the past. The Task Force will build on them. It will build on the innovations that have taken place at NIH. It will build on the regulatory initiatives implemented by the FDA. It will build on community- based efforts to improve the quality and direction of clinical research. And it will build on efforts to bring together people working to find effective treatments of AIDS and HIV-related disease.

"From the start, the Task Force will seek input from numerous groups including the Institute of Medicine, the Future Directions of AIDS Research Project, and the many Federal Advisory Committees that have done ground-breaking work in AIDS drug development. Open collaboration and communication are essential to move forward.

"The first meeting of the Task Force will be held this winter -- or at the latest -- in early spring. Over the next thirty days, nominations will be sought from the public as to who should serve. Public nominations will help create a task force that is composed of people with both competence and compassion and the diversity that is reflective of the epidemic.

"The Task Force represents a very important step forward and I hope it may be a model for other issues. For the first time in the fight against HIV-related disease, the United States will have a systematic over-arching effort to coordinate drug development to treat HIV infection and HIV-related diseases. The Task Force will serve as an example of how government and private leadership can be used to focus national resources on national problems. By working in partnership -- the pharmaceutical industry, the not-for-profit sector, private citizens, and the government, can and will get results."

Comment

No one can be sure what will come from this effort -- or what any medical research might produce. While it is impossible to guarantee results, we can and must bring the right people, resources, procedures, and commitments to the job. The creation of this Task Force shows that, finally, there is the national commitment to the kind of coordinated program that can get results.

Address for Nominations

To nominate persons for the Task Force, write to: Dr. Randy Wykoff, Office of AIDS and Special Health Issues, U.S. Food and Drug Administration, Room 12-A40, 5600 Fishers Lane, Rockville, MD 20857. Nominations must be received in December. The Public Health Service will compile them and make recommendations to Secretary Shalala.

A formal notice is being published in the FEDERAL REGISTER, December 2.

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