What work does the FDA do here? It is the work of large investments or initiatives to prove safety and efficacy and the FDA makes decisions.
If anything we live in a world where we need better provisions for these illnesses similar to https://www.congress.gov/bill/118th-congress/senate-bill/190...
Waiting for phased trials when you understand the research and hypothetical risks is torture. Especially when many drugs have proven safety profiles where the only harm is financial.