Right to Try Laws

An Opportunity for Physician, Public, and Private Sector Collaboration
PRS Briefs
PRS Policy Brief 1516-12
Monday, May 23, 2016

The state of New Hampshire recently introduced House Bill 1138 (NH HB 1138) which establishes the Terminal Patient’s Right to Try Act, a piece of legislation which “allows a patient with a terminal illness access to investigational drugs, biological products, and devices.” This bill seeks to allow terminally ill patients to try experimental treatments that have completed phase I testing and remain in clinical trials but have not yet been approved by the Food and Drug Administration (FDA). Right to Try (RTT) laws have spread across the country over the past two years. Colorado became the first state to pass an RTT law in May of 2014 and twenty-seven other states followed suit with their own RTT legislation. Advocates of such policies believe that RTT laws represent a way to bypass the slow FDA approval process, heighten awareness of investigational treatments, reduce deaths from terminal illnesses, and improve patient access to such treatments. Others oppose these laws because drug provision is not guaranteed and drug companies are reluctant to provide drugs outside the supervision of the FDA. Moreover, the laws can create false hope for patients due to the potentially prohibitive costs of treatment and the risk of a more painful, hastened death.

Currently, there is no way to know if RTT laws are helping or harming patients and pharmaceutical companies. Given that RTT laws continue to proliferate around the country, a potential policy option to address this issue consists of amending RTT laws to require some form a mandatory reporting. This reform would allow for the creation of a database tracking outcomes for RTT patients. Such a database would inform patients, physicians, pharmaceutical companies, and policymakers on the efficacy and potential consequences of RTT policies and guide future policy revisions.