Thanks to the Food and Drug Administration’s lengthy approval process, it takes over a decade and a billion dollars for new medicines to get to market. In the meantime, Americans who have exhausted all government-approved options are dying while potentially lifesaving treatments flounder amidst bureaucratic red tape. Sometimes, Americans are denied access to the same lifesaving treatments that are already helping patients overseas, even though many of those medications were developed or produced in the United States. But beyond the Washington impasse, there is hope in the states.
In the latest issue of Engage, Evan Bernick, Assistant Director of the Institute for Justice’s Center for Judicial Engagement, reviews Goldwater Institute President Darcy Olsen’s new book, The Right to Try: How the Federal Government Prevents Americans from Getting the Lifesaving Treatments They Need, and makes the case for an engaged judiciary that will recognize and enforce the constitutional right to medical self-preservation. Designed by the Goldwater Institute, state Right to Try laws allow the terminally ill to try investigational medications that have passed FDA Phase 1 safety testing but are not yet fully approved for market. In just two years, 24 states have passed laws to give patients who have exhausted every government-approved option a chance to fight for their lives.
The Right to Try “is at heart an optimistic book,” Bernick says. “It is optimistic about the American people; it is optimistic about the future of medicine; it is optimistic about the success of the Right to Try movement.” But Bernick is not so optimistic about the courts, cautioning that, without an engaged judiciary, the right to self-preservation – the Right to Try to save one’s own life – may remain vulnerable.
To that end, Bernick calls upon courts to abandon the so-called “rational-basis test,” which forces people to prove they should be free to seek lifesaving treatments when they’ve exhausted all hope, and instead require the government to justify its regulations with real evidence that the medicines patients seek are unsafe. If a dying patient wants to try a treatment that may save her life, the government should not stand in her way, even if the treatment might fail.
Courts should not force the terminally ill to beg the government for the right to to try to save their own lives, Bernick argues, but instead must enforce the Framers’ vision of a Constitution to “ensure that the most fundamental of all rights . . . is not extinguished by [the people’s] servants in Washington or in their state capitals.”