Do Patients Have a “Right to Try” New Medicines Before the FDA Approves Them?

Earlier this month, Colorado governor John Hickenlooper signed the nation’s first “right to try” law. The law allows a patient suffering from a disease, for which no medicine has been approved by the Food and Drug Administration (FDA), to try an experimental new medicine before the agency approves it. The law allows, but does not force, drug-makers to provide their experimental drugs to patients. Other states, such as Louisiana and Missouri, are set to follow.

These patients are in dire straits. They suffer from diseases for which there is no other known treatment, and they have short life expectancies. Most of us cannot imagine being in their position: In their search for a cure, they are willing to take far greater risks than most would accept.

Although the FDA has an exemption for “compassionate use,” that exemption requires jumping through too many bureaucratic hoops to be useful. So, scholars at the Goldwater Institute developed the idea of state “right to try” laws that would enable residents to use experimental new drugs without agency approval.

My first reaction when learning about the Goldwater Institute’s successes in moving this legislation through state legislatures was that the FDA would surely assert pre-emption based on the Constitution’s Supremacy Clause. The Goldwater Institute is the home of impressive legal thinking and activism, so they have surely developed a legal strategy, if they need one.

However, maybe the federal government will not react. After all, Colorado allows not only the medicinal use of marijuana, but also the purchase and possession of small amounts of marijuana for so-called “recreational” use. The Obama Justice Department does not litigate against state laws liberalizing marijuana use.

It would reflect a very perverse sense of justice for the U.S. government to act against a state law allowing desperately ill patients to try promising, experimental new medicines, while allowing Colorado’s marijuana market to thrive unmolested.

John R. Graham is a Senior Fellow at the Independent Institute.
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