NOV-18-09  The Forum reconvened key stakeholders to continue discussions on HIV Expanded Access Programs following the release of the revised FDA regulations on "Expanded Access to Investigational Drugs for Treatment Use."

2009 Update on Rethinking Approaches to Expanded Access Programs

Background:

Expanded access programs were developed to provide access and make available promising investigational drugs to patients who have exhausted all currently approved drug therapies and a critical component in HIV drug development.  Unlike any other disease or illness, the HIV field has the most experience with expanded access programs with 26 drugs made available through this program.

In February 2007, the Forum for Collaborative HIV Research organized a one-day roundtable meeting to discuss HIV antiretroviral expanded access programs (EAPs) and how they might be improved to meet the needs of patients, clinicians, industry sponsors, and regulatory agencies. 

Two years later, the Forum reconvened key stakeholders to continue discussions on HIV Expanded Access Programs following the release of the revised FDA regulations on "Expanded Access to Investigational Drugs for Treatment Use." This roundtable provided a neutral forum for key stakeholders from the pharmaceutical industry; regulatory governmental agencies; patient, community and advocacy groups; researchers, and providers to discuss the current and future HIV expanded access programs for patients with limited or no treatment options.

The roundtable began with a brief review of the 2007 meeting, followed by a series of presentations and discussions from meeting participants.

Objectives: 

• To review expanded access programs sine the 2007 FCHR meeting
• To evaluate the current need for expanded access programs
• To review the new FDA rule "Expanded Access to Investigational Drugs for Treatment Use" and its impact on expanded access for HIV patients in the Untied States
• To discuss potential study designs for future expanded access programs
• To discuss the challenges of administering expanded access programs

Status:

The roundtable discussion took place on November 18, 2009 in Washington DC.