One item that stakeholders may have missed, given the almost daily FDA developments, was the agency’s announcement that it will continue to improve and clarify its expanded access program (EAP). Specifically, FDA
- updated its EAP webpage to streamline content and make the page more user friendly;
- established an agency-wide Patient Affairs Staff and Health Care Provider Affairs Program to increase FDA engagement with stakeholder groups;
- established an agency-wide Expanded Access Coordinating Committee to facilitate cross-center communications and discussion of cross-cutting issues; and
- established a work group for the implementation of the Federal Right to Try law.
These follow a May 2018 independent assessment commissioned by the agency, which found that while stakeholders reported positive overall perceptions of the EAP and FDA’s role, there continue to be “pain points.” For instance, there continues to be confusion regarding program navigation, difficulties with multi-stakeholder coordination, and administrative burden.