There has been significant discussion lately about making it possible for patients to access drugs that are not yet approved for use in certain cases. Desperate patients might view this access as their last, best hope — even though the risks and benefits of these items are not yet fully known. Right to try laws and expanded access programs are attempts to improve this access. However, an important caveat is that neither requires a manufacturer to provide an unapproved drug to a patient.
We found an article online about right-to-try and expanded access that summarizes the differences between the two programs. This information may be helpful to IRB reviewers looking at expanded access applications and to investigators and clinicians who encounter a patient asking about right-to-try. We encourage you to read the entire article, and click on some of the links it includes.