AEGiS-PRn: FDA to Receive Public Testimony on Immune Based Therapies for HIV

Important note: Information in this article was accurate in 2000. The state of the art may have changed since the publication date.

FDA to Receive Public Testimony on Immune Based Therapies for HIV

PRNewswire - Monday October 16, 2000

NEW YORK, Oct. 16 /PRNewswire/ -- Over the past 14 months, AIDS treatment activists, many of whom are members of The HIV Immune Based Therapy Working Group have placed pressure on the Food and Drug Administration regarding the FDA process, procedures and review of immune based therapies for the treatment of HIV disease. In a surprise turn of events by the FDA Antiviral Committee, a meeting is scheduled to take place Oct. 16 to discuss these issues.

The pressure placed on the FDA by AIDS treatment activists over the past 14 months about the review process of immune based therapies including IL-2, made by Chrion, and Ampligen, made by Hemispherx Biopharma is coming to a head today as a controversial meeting, held in Washington D.C. and open to the public, is convening to discuss how the Antiretroviral committee should proceed in its review of these therapeutic options for people with AIDS.

"The FDA has been slow to acknowledge that there is a lack of meritorious review procedures in place to ensure scientifically valid consideration of these clinical options," said Jeannie Gibbs of the IBT Working Group.

The FDA posted a notice (with limited distribution) about the proposed contents of the meeting.

It is hoped by many AIDS treatment activists that the FDA will use this opportunity to begin to catch up with the rest of the clinical community involved in HIV research and allow for some strong determining results that will encourage the development of valid clinical research on immune restoration for HIV disease.

For more information on this meeting please contact: Nancy Chamberlin, or Beverly O'Neil, Center for Drug Evaluation and Research (HDF-21), Food and Drug Administration, 5600 Fishers Lane, (for express delivery) 5630 Fishers Lane Rm. 1093) Rockville, MD 20857, or by e-mail: CHAMBERLINN@CDER.FDA.GOV. Contact persons can be reached by telephone at 301-827-7001.

For more information contact: Alanzo Massee, HIV Immune Based Therapy Working Group at 718-299-9429.

SOURCE: HIV Immune Based Therapy Working Group

001016
PR001012

Copyright © 2000 - PRNewswire. All rights reserved. Reproduced with permission. Reproduction of this article (other than one copy for personal reference) must be cleared through PRNewswire, Permissions, 810 Seventh Ave., 32nd Floor, New York, NY 10019 http://www.prnewswire.com.

AEGiS is a 501(c)3, not-for-profit, tax-exempt, educational corporation. AEGiS is made possible through unrestricted funding from Broadway Cares/Equity Fights AIDS, Elton John AIDS Foundation, National Library of Medicine, and donations from users like you.

Always watch for outdated information. This article first appeared in 2000. This material is designed to support, not replace, the relationship that exists between you and your doctor.

AEGiS presents published material, reprinted with permission and neither endorses nor opposes any material. All information contained on this website, including information relating to health conditions, products, and treatments, is for informational purposes only. It is often presented in summary or aggregate form. It is not meant to be a substitute for the advice provided by your own physician or other medical professionals. Always discuss treatment options with a doctor who specializes in treating HIV.

Copyright ©1980, 2000. AEGiS. All materials appearing on AEGiS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of AEGiS, or the party credited as the provider of the content. .