Bioethics Blogs

“Right to Try” Laws, Compassionate Use, and Adverse Events: A Second Cautionary Tale

by Alison, Bateman-House, Ph.D., MPH

In 2014, Colorado became the first state to debate and then pass a so-called “Right to Try” law. In early 2015, there are now five states that have such laws: Colorado, Michigan, Louisiana, Arizona, and Missouri. The Utah and Virginia state legislatures have passed their own right to try laws, both of which await signature by their respective governors, and over twenty other states are actively debating right to try legislation.

These right to try state laws are based on a model bill that was circulated by the Goldwater Institute, a libertarian think tank based in Arizona. According to the Goldwater Institute, the U.S. Food and Drug Agency’s regulations for new drugs take a toll on terminally ill Americans, a number of whom die before they can get access to potentially lifesaving experimental treatments. Thus, the model law cuts the FDA out of decisions about whether patients may be granted access to experimental treatments. Under right to try laws, a patient may ask the company developing a drug or device to make that experimental medical product available to her. The company does not have to provide it, and if the company does decide to provide the patient with the experimental drug or device, they may charge her for it (and her insurance company has no obligation to pay for it). But, if the patient and the company come to a mutually agreeable decision, there is no need to seek FDA approval of their plan. This is a controversial change in that such decisions were previously understood to be regulated by the FDA under its federal legal mandate.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.