ON your question @jwoody1000 about legal battles, here is an...

ON your question @jwoody1000 about legal battles, here is an interesting case

Abigail Alliance for Better Access to Developmental Drugs v. von Eschenbach, (D.C. Cir.). On August 7, 2007, the D.C. Circuit Court, sitting en
banc, issued an opinion finding that there is no Constitutional right of access toexperimental drugs for terminally ill patients. Abigail Alliance for Better

You will find the summary here on the FDA's own publication:

https://www.fda.gov/media/73014/download

The appeal court (D.C Circuit) allowed the Government's petition to re-hear the case and issued an opinion (en banc) which is summarised as follows:

The August 7,2007 en banc decision was written by Judge Griffith, the dissenter on the original panel. The Court concluded that there is no deeply rooted right to procure and use experimental drugs in our nation’s history and traditions. Because there was no fundamental right implicated, FDA’s regulatory scheme would be subject to the rational basis standard, which it satisfies.

That strongly suggests the FDA's decision-making is also subject to judicial review and it must stand up to scrutiny for having a rational basis because there is no "deeply rooted" right to experimental drugs. That was a 2007 decision and in 2018 the Trump Administration passed the "right to try [experimental drugs]" law, so query the result if that same set of facts was re-run now. However, it's still plainly arguable that the FDA's decisions have to be rational and not unreasonable.