[mattkrause]

That's not entirely true.

The FDA has a "new clinical investigation" program that is supposed to reward people running clinical trials. If you collect data showing efficacy of a new use of a previously-approved drug, you can "earn" the exclusive right to market it for that condition. Of course, someone has to actually do it...and the numbers don't always pan out.

[fnordpiglet]

I think a part of this is also the FDA has been really reluctant to touch testosterone producing substances - there was a company trying to get approval for a patented isomer of clomiphene and they took it through phase 3 and the fda indicated they wouldn’t approve it because they viewed the primary benefit of not being castrating as not compelling enough for a new treatment for low T. Their reasoning to my memory was mostly elderly men suffer from low T and they wanted to discourage what they viewed as a growing trend of lifestyle testosterone treatment. As a clomid user I bought the companies stock and followed it closely through the process and was terribly discouraged about the FDAs processes as a result (and my wallet too!). I’ve been trying to dig that stuff up but it appears the company died as a result and googles not finding the FDA communications. This was like almost 10 years ago.