Notice of Meeting

FDA discussion with the Community
The Role of Resistance Testing in HIV Drug Development

This notice announces an informal meeting being planned by FDA with members of the HIV/AIDS community to discuss the potential role of HIV resistance testing in the development of new pharmaceutical therapies for treating HIV.

The meeting is planned for September 17, 1999, at the Ramada Inn, located at 8400 Wisconsin Ave in Bethesda, MD, (phone 301-654-1000) Embassy Ballroom, from 2:00 - 4:00 PM.   The meeting is part of the preparation for an upcoming meeting of the Antiviral Drug Products Advisory Committee, which is scheduled for November 2-3, 1999, and is announced in an accompanying document.

The purpose of the meeting with the community is to provide the agency with an opportunity to hear the thoughts and concerns of the community so that they may be integrated and reflected in the discussions and deliberations of the Advisory Committee at the November meeting.

We envision this meeting with the community as a "listening" opportunity for the agency, following a brief introductions of current issues under consideration related to the use of resistance testing with the context of drug development.

Please note that this discussion will be restricted to the drug development context only, and will not include discussion of issues related to regulation of the tests themselves, or treatment management issues.

The Community meeting is planned in conjunction with a meeting of the  Blood Products Advisory Committee meeting  which will be discussing issues related to regulation of the HIV resistance tests, so that interested parties can attend without additional travel.

The Agenda for the November 1999 Antiviral Drug Products Advisory Committee meeting, which follows, provides some background for the discussion:

AGENDA:
Presentations and committee discussions will address issues related to testing for development of resistant Human Immunodeficiency Virus (HIV-1), with an emphasis on its potential role in antiretroviral drug development. The primary objectives of these deliberations are to obtain advisory committee recommendations on the amount and type of resistance data needed to support both preclinical and clinical development of antiretroviral drugs and antiretroviral product labeling. This two-day meeting will explore the following scientific issues: performance characteristics of genotypic and phenotypic assays; definitions of antiviral drug resistance; relationships between the development of mutations or reduced susceptibility and treatment outcome; and available evidence supporting the clinical utility of testing for the development of antiviral drug resistance. In order to prepare presentations and discussions for the meeting, the agency is requesting interested persons to submit in writing the following types of relevant data, information, and views:

• Pre-clinical and/or clinical trial data on the relationship between the development of HIV mutations and changes in susceptibility to antiviral therapies.
• Prospective or retrospective clinical trial data on the relationship between genotype and/or phenotype and treatment outcome.
• Proposals for incorporating HIV resistance testing in clinical trial design.
• Proposals for utilizing information derived from HIV resistance testing to support product labeling.

Written comments on these issues may also be submitted to the agency through September 30, 1999.  Comments should be sent to Docket No. 99N-2670 at the following address:

Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, room 1061, Rockville, MD 20852

This meeting will follow the Blood Products Advisory Committee meeting
on September 17, 1999

Office of Special Health Issues
oshi@oc.fda.gov
Office of International and Constituent Relations
Food and Drug Administration
September 14, 1999

Return to OSHI HIV/AIDS Home Page