Right-to-Try Laws Now in 5 States
However, I have seen no evidence that any manufacturer of an experimental drug is taking advantage of these laws to supply medicines to desperately ill patients in these states. This is understandable: Doling out the medicines to needy patients threatens the sanctity of clinical trials and, therefore, FDA approval.
Congress needs to reform the rules governing the Food and Drug Administration to make use of more real-world evidence in approving new medicines (as described in a recent book by Peter Huber, The Cure in the Code). This is statistically challenging and not to be undertaken lightly. Nevertheless, if more states pass “right to try” laws, I expect that Congress will see the necessity of taking action to relieve the pain of patients suffering needlessly from FDA’s regulatory burden.