An FDA Regulator ' s View of the Issues with the FDA in the Matter of Treating Aging

A charitable view of the FDA is that it is populated by well-meaning people who happen to believe that (a) any cost in lives, time, and funds is worth it in order to prevent harm by commission, and (b) zero risk is a possible goal in medicine. The Hippocratic Oath Enforcement Agency, if you like. There are much less charitable views, given the present state of regulatory capture that dramatically raises costs and slows development, as well as the invisible graveyard of countless lives lost to the absence of medical technologies that would otherwise exist and be widely available at reasonable prices. There is no established regulatory path to approval for treatments that target aging. So at present biotech and pharma companies working on therapies that target mechanisms of aging pick a single age-related disease in order to gain regulatory approval. It is assumed that there will be widespread off-label use thereafter. There are efforts underway to pave a better road, but this will take a good long time at the usual glacial pace of large regulatory agencies. An endocrinologist by training, Kitalys Institute founder Alexander Fleming is well qualified to take on the regulators. He spent more than a decade at the FDA, where he led the medical reviews that resulted in approval of drugs including metformin, as well as the first statin, insulin analog, and PPAR agonist. Getting approved longevity and geroscience therapies into the public domain is what Kitalys and it...
Source: Fight Aging! - Category: Research Authors: Tags: Daily News Source Type: blogs