The EA Navigator Mission
The Expanded Access Navigator, or EA Navigator, represents a unique partnership between the Reagan-Udall Foundation for the FDA, patient advocacy organizations, the pharmaceutical industry, and the federal government to provide clear, digestible information on single-patient EA.
Single-patient EA has gained attention over the last few years because of high profile social media campaigns, press coverage, and legislative actions. The amount of information available on expanded access has also increased dramatically, including EA information shared by the FDA and many pharmaceutical companies. It is still difficult, however, to find clearly organized, easy-to-understand information on the EA request process in one place.
To address this need for clarity and information about EA, the Navigator was created. This website provides a roadmap to guide patients, caregivers, and physicians through the request process, which involves various decisions, steps, and players, including pharmaceutical companies, the FDA, and Institutional Review Boards (IRBs). The Navigator clarifies the process for people who need information on investigational therapy or treatment options, which include clinical trials and EAPs, as well as single-patient EA. The goal of the Navigator is to increase understanding of the request process, not to encourage or discourage requests for expanded access.
The EA Navigator provides information and resources for non-emergency situations.
If your patient is in an emergency situation where access is needed in a matter of hours or days and a company is willing and able to provide the needed product, contact the FDA directly through its Division of Drug Information at 855-543-3784 or email@example.com
The FDA also responds to questions from patients about expanded access through its Office of Health and Constituent Affairs at (301) 796-8460.
For questions concerning the Navigator website or about the Reagan-Udall Foundation for the FDA, please email firstname.lastname@example.org. Please keep in mind that we are unable to answer questions or comments about expanded access that do not pertain to the Navigator program.
Understanding Single-Patient Expanded Access
For the expanded access process to work effectively, physicians, patients, the FDA, Institutional Review Boards and the pharmaceutical industry need to communicate and collaborate. The Navigator fosters an effective EA process by providing the context, considerations, and practical guidance needed to determine if a clinical trial, existing expanded access program, or single-patient expanded access is an appropriate option.
Currently, the Navigator focuses on oncology treatment, but the process is similar for patients with other serious or life-threatening diseases or medical conditions.
Because investigational treatments are still under study, it is not known if their potential benefits outweigh their risks. The Navigator is designed to help patients, physicians and caregivers understand this when considering the use of an investigational treatment. Most treatments under investigation do not ultimately demonstrate both effectiveness and that their benefits outweigh their risks, and therefore never come to market.
About the Reagan-Udall Foundation
The Reagan-Udall Foundation for the FDA is a non-profit 501 (c)(3) created by Congress to advance regulatory science critical to helping the U.S. Food and Drug Administration (FDA) meet its mission. The Foundation works collaboratively with stakeholders including academia, patient groups, industry groups, and FDA scientists. The EA Navigator exemplifies the Foundation’s process of working with public and private stakeholders to develop coordinated resources containing clear information for use by patients, healthcare providers, and others.
The Foundation would like to thank the partners who have come together to develop this important resource for patients with unmet medical needs.