28 Pages Posted: 10 Jul 2015
Date Written: July 9, 2015
In 2014, states began enacting laws giving terminally ill patients a “right to try” investigational drugs. Right to try laws are the latest policy development in a decades-long struggle between advocates of liberal access to investigational drugs and defenders of access restrictions. According to access advocates, physician opinion and minimal safety testing are an adequate scientific basis for allowing terminally ill patients to try investigational drugs. But science and policy experts are virtually unanimous in criticizing right to try laws. According to the experts, more rigorous scientific and regulatory oversight is necessary to justify wide patient access. In defense of their position, experts cite data on investigational drug risks and low success rates, as well as the public interest in a rigorous drug evaluation system. Access advocates use a different strategy, however, one that highlights stories of patients and families pleading for investigational drugs. These stories strongly influence legislative and public opinion on access policy. To mount an effective response, experts must tell stories illustrating the harm that liberal access can produce. In this arena, experts must convey their concerns in ways that are meaningful to lay decision-makers.
Keywords: investigational drug access, Food and Drug Administration, terminally ill patients
Suggested Citation: Suggested Citation
Dresser, Rebecca, The 'Right to Try' Investigational Drugs: Science and Stories in the Access Debate (July 9, 2015). Texas Law Review, Vol. 93, 1631; Washington University in St. Louis Legal Studies Research Paper No. 15-07-01. Available at SSRN: https://ssrn.com/abstract=2628679