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by dentalperson 1665 days ago
> The notion that somehow aging is “special” and therefore shouldn’t be regulated like “normal” diseases is not convincing. The same argument could be made about any number of other conditions. For example cancer – for years we’ve been told it’s not one disease but hundreds of diseases, and therefore we need to think about it differently. And yet, cancer medications including personalized therapies such as CAR-T seem perfectly capable of getting approved within the existing framework of the FDA.

This seems to miss the main point about regulation that the longevity researchers face. Aging is not recognized as a disease by the FDA, so aging treatments are not allowed to have the same treatment and development pipeline. To 'be regulated like “normal” diseases' is in fact what many longevity companies would benefit from.

2 comments

There's no need for the FDA to recognize aging itself as a disease to get a therapy through clinical trials. If you have a working aging-prevention or aging-reversal therapy, pick one of many age-associated diseases like arthritis or osteoporosis. Run a trial showing that it successfully and safely treats that specific condition. Once it's approved for any condition it can be approved off-label for other conditions by a willing physician.
> Aging is not recognized as a disease by the FDA, so aging treatments are not allowed to have the same treatment and development pipeline

This is valid but immaterial criticism. There are no treatments reaching their clinical endpoints in a rigorous way. The FDA isn’t blocking anything because nothing has made it to its level. That makes complaining about the FDA putting the cart before the horse at best and a red herring for certain personalities at worst.