Book Review: The Right to Try

[MachineGhost]

[quote=http://www.fed-soc.org/publications/det ... ght-to-try]
Do dying Americans have the right to try to save their own lives and the lives of their children? The question seems absurd because the answer is—or seems as if it should be—obvious. But every year millions of Americans suffering from fatal diseases are denied access to safe, potentially life-saving medicines by the federal government. Darcy Olsen’s The Right to Try is a shocking, sometimes heartbreaking, yet ultimately hopeful account of an ongoing tragedy and the growing campaign to put an end to it.

Federal law—specifically, the Food, Drug & Cosmetic Act1 (FDCA)—generally prohibits marketing and distributing drugs that have not yet been approved by the Food and Drug Administration (FDA). It takes an average of fifteen years to bring a new drug to market (Olsen, 215). Americans suffering from fatal diseases for which there is no FDA-approved treatment have limited options. For all but the very few terminally-ill Americans who are qualified for and able to participate in clinical trials of unapproved drugs, or receive unapproved drugs through the FDA’s “compassionate use” programs (which provide terminally-ill patients with access to drugs on a case-by-case basis), the delay is deadly. As President of the Goldwater Institute, Olsen champions “Right to Try” (RTT) laws—state laws that are designed to expand access to “investigational” drugs that have passed basic safety trials required by the FDA but have not yet been fully approved.

RTT laws have proven extraordinarily popular. As of this date, they have been approved in 24 states; in 14 of those states, they were enacted by the state legislature without a single dissenting vote in either house (25). Their popularity evinces a widely-held conviction among Americans that we have a right to try to save our own lives from deadly diseases or other fatal conditions. But because federal law trumps conflicting state laws, RTT laws are vulnerable to legal challenges by the FDA, and drug manufacturers face fines and even imprisonment for FDCA violations.2 If the right to try is to be secured, federal courts must be prepared to recognize and enforce the constitutional right of self-preservation. Thus far, they have abdicated their responsibility to do so in cases involving investigational drugs.

In this essay, I will summarize Olsen’s book, argue that the Constitution protects the right of terminally-ill patients to try to save their own lives, and sketch the contours of a judicial approach that will ensure that the right to try is consistently enforced in our courts.
[/quote]