Science policy experts at Rice University’s Baker Institute for Public Policy have published a report declaring that the “right to try” laws, which allow terminally ill patients early access to experimental drugs and medical devices, prioritize speedy access over safety and efficacy.
Kristin Matthews, a fellow in science and technology policy at the Baker Institute, and Michelle Rubin, a Baylor College of Medicine graduate student in biomedical science, co-authored the report titled “The Impact of Right to Try Laws on Medical Access in the United States.”
The “right to try” laws were put into place to give terminally ill patients access to investigational drugs. According to Matthews and Rubin, the primary goal of these laws is to eliminate FDA interference and ethical requirements to expand the access application process.
The report also looks at the FDA’s background and purpose, the process of clinical trials, and the history of expanded or early access policy that grants patients access to experimental drugs during Phase 2 or 3 trials if alternative therapies do not exist.