Report examines programs that would give HIV-positive people access to new drugs before final federal approval

Jun 22 2007

"Rethinking the Approach to Expanded Access Programs," Forum for Collaborative HIV Research: The report says that reform of expanded access programs that allow HIV-positive people to take new drugs before final federal approval is needed.

Although EAPs can be important to HIV-positive people who have developed resistance to currently available drugs, the system for providing access to experimental drugs is "fragmented and underfunded," according to the report.

It adds that the system "discourages academic health centers and private physicians from participating."

The report reviews the problems associated with the system and provides guidelines aimed at improving it, including a recommendation that pharmaceutical companies reimburse health care providers for EAP costs.

"The goal of expanded access programs is to make promising drugs in the late stages of clinical trials available to patients who urgently need treatment and have exhausted all currently approved therapies," Ben Cheng, deputy director of the forum said, adding, "Unfortunately, the current mechanism for early access to these promising drugs serves neither patients, companies nor regulators" (Forum for Collaborative HIV Research release, 6/14).