The FDA does not provide good guidance on what treatments should be applied in what situations. They approve drugs for a limited set of uses and that’s it. Most drugs are applied “off label” which the FDA rules that drug companies specifically cannot comment on—so not only does the FDA not provide guidance on the most common use for most medications, they actually prevent that guidance from being provided.
One reason the company might not be allowed to comment on is that they lack the knowledge in that space so would only be marketing from a basis of ignorance.
However, the FDA does not prevent such guidance as a quick look at sited like WebMD or PDR will generally include information on off label use.
My understanding is that off-label often means that the potential patient is not within the bounds of the clique of patients included in the approved clinical trials. We don’t usually perform clinical trials on children or pregnant women, for instance. Alternatively, strong scientific evidence is found that a drug works on a related disease to the actual target. It may well make sense to use drugs off label where the clinician can be comfortable that the benefits out-way the possible harms. In other cases, of course, it would be extremely poor medicine. In any case, having statistically significant and validated evidence that a drug actual does something useful, is non-negotiable IMO.
The FDA does not provide good guidance on what treatments should be applied in what situations. They approve drugs for a limited set of uses and that’s it. Most drugs are applied “off label” which the FDA rules that drug companies specifically cannot comment on—so not only does the FDA not provide guidance on the most common use for most medications, they actually prevent that guidance from being provided.
One reason the company might not be allowed to comment on is that they lack the knowledge in that space so would only be marketing from a basis of ignorance.
However, the FDA does not prevent such guidance as a quick look at sited like WebMD or PDR will generally include information on off label use.
My understanding is that off-label often means that the potential patient is not within the bounds of the clique of patients included in the approved clinical trials. We don’t usually perform clinical trials on children or pregnant women, for instance. Alternatively, strong scientific evidence is found that a drug works on a related disease to the actual target. It may well make sense to use drugs off label where the clinician can be comfortable that the benefits out-way the possible harms. In other cases, of course, it would be extremely poor medicine. In any case, having statistically significant and validated evidence that a drug actual does something useful, is non-negotiable IMO.