There is already an expanded access law for compassionate use. The FDA approves most requests, but the drug company usually doesn't agree to supply it.
This "right to try" law, if it benefits anyone, will benefit only the very rich. Drug companies will charge an arm and a leg for the new drugs, if they are able to supply them at all. Insurance companies certainly won't cover the cost.
Doctors who have taken an oath to do no harm will be reluctant to prescribe drugs of unconfirmed safety even if they are free of legal liability. Desperate patients may be willing to try anything, even if it kills them more quickly. Because a Phase 1 trial only shows a dose safety relationship, it is unclear whether a drug has "passed" or not. What if a drug has 50% of patients experiencing Grade 3 symptoms, how can anyone assess whether it is worth the risk if the efficacy has not yet been discovered?
Also, I am unclear what is meant by "terminally ill patient." Is a man with newly diagnosed metastatic PC considered "terminally ill" even if he can be expected to survive 20 years with existing therapies?
Allen - not an MD
•PSA=7.3, prostate volume=55cc, 8/17 cores G6 5-35% involvement
•SBRT 9 yr onc. results
•SBRT 7 yr QOL results
•treated 10/2010 at age 57 at UCLA,PSA now: 0.1,no lasting urinary, rectal or sexual SEsmy PC blog