This same scenario isn't uncommon, but the success of it is uncommon..............the drug efficacy for macular degeneration is what I am talking about.
When drugs are approved by the FDA, they are approved for specific uses.............each specific use of every drug has to have various efficacy tests, tox, safety tests, etc. In many cases tox and safety don't need repeating.
When a drug is approved by the FDA, nothing can be changed...not even the writing in the product insert.........unless the FDA gives additional approval. In most cases, additional approval needs to be complimented with additional testing.
When one is testing each drug, side effects are encountered and sometimes they are quite beneficial. Dr's know this and they do, of their own accord and without FDA sanctions, use the drug to solve other health problems. However, it[s not completely legal and may be unethical depending on who you are and how badly you need the drug!
the company that produces the drug cannot simply give their OK to use it in another way.......they must go through the appropriate regulatory process to get approval for the additional use.
This does not mean they have to hose the public with massive price increases, but it isn't cheap for them to go through any of regulatory processes necessary for approval. |
