Enhancements to EA Navigator Improve Patient Access to Investigational Therapies

Embargoed until 9 a.m. EDT June 3, 2019

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Expanded Access Navigator Improves Patient Access to Investigational Therapies

New enhancements make it easier for patients, caregivers and healthcare providers to find crucial information

(Washington, DC) Putting investigational therapies at the fingertips of patients who have exhausted all other treatment options, the Reagan-Udall Foundation for the FDA now includes expanded access programs in the Expanded Access Navigator. The enhanced functionality of the EA Navigator was announced this morning as part of the Project Facilitate & EA Navigator: Working Together to Enable Patient Access to Investigational Oncology Drugs press briefing at the 2019 Annual Meeting of the American Society of Clinical Oncology.

The EA Navigator now incorporates expanded access programs registered with ClinicalTrials.gov, creating a one-of-a-kind resource to help healthcare providers, patients and caregivers quickly identify investigational drugs and streamline the physician/drug company communication process. Users can now search the EA Navigator by disease, drug or company to retrieve detailed descriptions and eligibility criteria for expanded access programs offered by pharmaceutical companies listed in the EA Navigator. Searches can be made in free text, so results can be found even if the user is unsure of spelling or variations in medical terminology.

“For the first time, those who need quick access to drug availability and expanded access options can find it all in one place, without having to visit site after site or sift through thousands of studies that don’t meet their needs,” says Amar Bhat, PhD, interim executive director of the Reagan-Udall Foundation for the FDA.

Launched in 2017, the EA Navigator is a web resource designed to walk healthcare providers and patients step-by-step through the exploration and use of investigational therapies and delivers transparent, concise and searchable information provided by companies about their expanded access policies. The EA Navigator exemplifies the Foundation’s commitment to working with public and private stakeholders to develop accessible, coordinated resources for use by patients, healthcare providers, industry and others.

“It’s important that drug companies update their expanded access listings in ClinicalTrials.gov as required by federal policy and ensure their company profiles are complete in the Navigator,” says Ellen Sigal, PhD, chair of the Foundation’s Board of Directors, stressing that listing in the Navigator helps companies comply with the 21st Century Cures Act.

Also known as compassionate use, expanded access can provide patients who have exhausted all other treatments and do not qualify for clinical trials access to investigational treatments not approved by the FDA. This expansion of the EA Navigator responds to the need expressed by patients and providers from across the nation and is one step in the Foundation’s effort to help all Americans live stronger, longer and healthier lives.

About the Reagan-Udall Foundation for the FDA

The Reagan-Udall Foundation for the FDA (FDA Foundation) is an independent 501(c)(3) created by Congress to advance regulatory science to help the U.S. Food and Drug Administration accomplish its mission. The FDA Foundation works to improve health and safety through stakeholder engagement and public-private partnerships that facilitate innovation, foster the use of real-world evidence, and identify modern tools and policies to keep pace with today’s rapidly evolving science.

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Lea Ann Browning-McNee
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