Yes @quartear !! My research lobbed onto this case as well...

Yes @quartear !!

My research lobbed onto this case as well (Abigail Alliance for Better Access to Developmental Drugs v. von Eschenbach, (D.C. Cir.). Check out the FDA's own summary of the appeal result that they sought from the original judgment:

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.

The FDA's decisions have to be rational or otherwise not unreasonable. What a precedent for MSB to follow! and the good thing is that there are enough aGvHD lobby groups out there (especially those whose kids are dying) with the standing to take on this appeal themselves, without MSB having to get their hands dirty.