Op Ed: Viral Load FDA Approval Delays

[David Scondras served on the Boston City Council for ten years, from 1983 through 1993. He is co-founder of Search for a Cure, a Boston organization with a mission of cutting red tape, both government and corporate, which interferes with development of or access to effective treatment for HIV.]

We have good news and bad news; as this is going to press, the FDA has just approved the Roche viral load test for use by clinicians for HIV prognosis, and for monitoring the activity of antiviral therapies. The bad news is that it took much too long and were it not for the intervention of many treatment activists, the FDA's "Biologics Division" (Center for Biologics Evaluation and Research, CBER) very well might have made a bad decision. Delays in approvals harm those HIV positive individuals who have insurance, including Medicaid, that may not reimburse without FDA approval. And unfortunately there is a tendency for the Biologics Division to delay until they receive significant pressure from the activist community.

These problems are a direct result of the lack of experience of CBER in evaluating treatments for HIV illness, compared with the experience of the "Drugs Division", (Center for Drug Evaluation and Research, CDER). The speed with which CDER moved on protease inhibitors stands in stark contrast to the delays and need for extensive advocacy campaigns at CBER.

Another example of CBER's erratic, slow and inconsistent behavior surrounds the effort to get a "Treatment IND" for access to the Salk therapeutic vaccine. After nearly a year of delay, CBER gave the green light for a phase III trial for this vaccine. Many people signed up since it might help, apparently has no side effects, is cost free to HIV infected people, and has very few restrictions on the use of any other therapies. However, many people who cannot get into the trial want access, so activists met with the FDA; at that meeting CBER staff made a commitment to allow an expanded access program, including Treatment IND status (the simplest legal method for getting new treatments to persons with HIV who otherwise cannot get them) for people with a CD4 count greater than 300. But when the decision arrived, it was for an open-label protocol [collecting research data] which the company specifically had said it cannot afford to undertake along with the $60 million phase III trial. We are now faced with the task of trying to get CBER staff to keep their word. This struggle continues.

The time has come to call for an HIV-positive, community-chosen ombudsman who would have the power to appeal any decision made by the FDA divisions to Commissioner David Kessler, with the requirement that any such appeal result in a written decision by Dr. Kessler within a stated and reasonable time.

Meanwhile, as a practical matter, it is time to move decisions on HIV therapies and diagnostic tests from CBER to CDER, because at least the drug division has had ample experience with the intricacies and unique problems and needs of the HIV positive community, which is clearly lacking in the biologics division.