Many libertarians have expressed interest in statutes, enacted in five states, which seek to give incurably ill patients access to “investigational” drugs which have passed the first stage in the FDA’s approval process but not reached final approval. Nice goal, but according to James Beck at Drug & Device Law:

…we don’t think these statutes are going to accomplish much, let alone achieve their purpose of making investigational drugs generally available to terminally ill patients having no other choices.

One obstacle is the supremacy of the FDA:

States can pass all the laws they want, but unless the FDA gives its okay to programs more expansive than its compassionate use (“expanded access”) program, nothing’s going to happen. It’s called “preemption.”

A second is liability. While the new crop of statutes are an improvement on earlier proposals which sought to conscript pharmaceutical companies’ participation, they still give drugmakers no strong protection from resulting lawsuits, and sometimes include language hinting at the reverse. Even though plaintiff’s lawyers would face their own challenges of proving causation and damages, there would still be unknowable legal downside with relatively scant upside, making for poor incentives to participate in the program by making investigational drugs available.

Filed under: FDA, pharmaceuticals