Bulletin of Experimental Treatments for AIDS, No. 4, November 1989
Debra A. Roy

In June 1989, NIAID* Director Dr. Anthony Fauci proposed a "parallel track" system for the early release of drugs that have not been fully approved by the FDA*. When implemented, the program will make promising drugs available to people who do not qualify for clinical trials or who have failed on approved therapies.

Although the final format for parallel track has not yet been formulated, a preliminary series of guidelines is now in place. Drugs under consideration for parallel track will have three characteristics in common: (1) they will have finished Phase I and pharmacokinetic* testing; (2) there will be some data available on their interactions with drugs in common use; and (3) they will have shown sufficient efficacy* to warrant wider release.

Special circumstances must also be present for a drug to qualify for release under parallel track. Drugs to treat a disease where no standard treatment is available will be given priority. In addition, parallel track status is more likely to be granted if a standard treatment causes adverse side effects or cannot be taken because of the use of another critically needed therapy.

Parallel track raises many complex issues. Two of these involve the legal ramifications of the program and the question of who will have access to it. Physicians and their patients who participate in the program accept responsibility not only for the participant's health, but also for any side effects that may result from the use of an unapproved drug. All parties in the program will need to understand clearly the risks involved. Even if educational programs take place, drug manufacturers and physicians may hesitate to participate in parallel track protocols because of the threat of litigation if the drug causes serious side effects.

Who will be eligible to receive drugs in parallel track protocols* has been one of the most difficult questions raised about the program. Potential participants are currently defined as those who have been excluded from Phase II efficacy trials because they do not meet trial requirements or because they have failed on currently approved therapies. Definitions for the word "failed" have not been finalized, and there is concern that some people who are in need of parallel track drugs will be excluded.

Before the parallel track program can be implemented, some difficult issues still need to be resolved. How will the program affect clinical trials? How will the cost of such a program be managed? Who will pay doctor and laboratory fees? Will medically indigent people be able to participate? How long will parallel track studies continue? Some of these questions may be answered by the "open label study regimen" for ddI, which appears to be an experimental step in the development of parallel track.

Treatment IND

Treatment IND (Investigational New Drug) is an established procedure for moving promising drugs through the FDA pipeline at an accelerated pace. In order for a drug to be considered for distribution through this program, it must have completed Phase I testing, show some evidence of efficacy, and show no extreme toxicities. Additionally, the drug must be in the process of being tested as an agent against a severe or life-threatening illness, such as AIDS. AZT was released in a modified Treatment IND program in 1987.

Unlike what is planned for parallel track, drugs are not usually considered for Treatment IND status until mid-to-late Phase II testing. This varies, however, depending on the data obtained in early trials, the severity of the illness involved, and the other treatments available. Some drugs are not given Treatment IND status until Phase III testing has already begun. On the other hand, the FDA recently released ddI under a Treatment IND protocol at the same time that Phase II trials of the drug are beginning.

In a Treatment IND protocol, the individual's private physician registers with the manufacturer, obtains and dispenses the drug, and agrees to collect data and meet other requirements that the manufacturer may have. These requirements, as well as the number of participants, will vary for each drug accepted into the program.

It must be stressed that policies and procedures pertaining to both parallel track and Treatment IND are still in flux. Much about the programs is subject to change, and the future of parallel track will depend in large measure on how well the open label study regimen works with ddI. However, it appears that these programs will expedite the release of drugs to many people who would not have been able to receive them otherwise.
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