To be eligible, the investigational drug cannot be approved for any FDA use, but Phase I of a clinical trial must be completed. The Right to Try law is aimed at increasing access to investigational products for those with life-threatening illness who have no other medical options and are unable to join a clinical trial. In the short-term, we are going to continue to work with anybody the FDA expanded access program for unapproved drugs and devices.” “We are very comfortable and used to processing the IRB review requirements for the expanded access pathway. “We have always as a company done our best to help anybody that needed expanded access,” he says.
“My prediction is that all reputable players - be they doctors, institutions, or companies - are going to decide to stick with expanded access,” says Alison Bateman-House, PhD, MPH, MA, a professor in the division of medical ethics at New York University Langone Medical Center.ĭavid Borasky, MPH, CIP, vice president of IRB compliance at the WIRB-Copernicus Group in Cary, NC, says his organization is taking a “wait and see” approach to the new law.
Given the circumstances, the prevailing thought is that the ongoing “expanded access” pathway to experimental drugs currently in place at the FDA will continue to be the preferred method. The law, however, has been dogged by implementation questions and remains in regulatory limbo. On May 30, President Trump signed into law the Right to Try Act, which seeks to give patients a new pathway to experimental drugs.
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