[Dion]

Originally Posted by Kybosh

No, drug development doesn't have a "fast track" that I'm aware of. First, there is all the preclinical tests (which I think is where this thing is just starting). Then there are three major steps in clinical trials and each step can take years. Finally, there must be all the approvals from all the big agencies like FDA. All this is also at the mercy of the company that is manufacturing as well. Unfortunately, most people that need an HIV drug can't easily afford it. Even if a drug is made a huge priority I would still expect it to take at least 10 years assuming it passes all tests.

http://idid.essortment.com/fdadrugapprova_rrgy.htm

The process of developing and testing a new drug is a lengthy one. The FDA estimates that it takes a little over 8 years to test a drug, including early laboratory and animal testing, before there is final approval for use by the general public. Various efforts, however, are underway to reduce the approval time.

However when it comes to promising experimental drugs........

Eight years is a long time to review a drug. Some patients, especially terminally ill patients, don't particularly care if the drug meets high standards of safety. They don't have the time. Taking any drug, in their view, is better than the alternative. So today's policies also allow some investigational drugs even before they are approved for marketing.

These new policies called "expanded access" protocols include the Treatment Investigational New Drug (IND) application and the parallel track mechanism. Both tracks allow promising drugs, not yet approved for marketing, to be used in moderately unrestricted studies where the intent is not only to learn more about the drug, especially about its safety, but also to provide treatment for people with no real alternative. But these expanded access protocols still require clinical researchers to formally investigate the drug in well-controlled studies and to supply some evidence that the drug is likely to be helpful.