The Reagan-Udall Foundation for the Food and Drug Administration (FDA) recently announced the release of a new online tool called the Expanded Access Navigator. The Navigator was developed for patients suffering from serious or life-threatening diseases who cannot find a therapy to suit them and are looking for potentially life-saving investigative drugs. The tool was developed by a team led by the Reagan-Udall Foundation in partnership with the FDA, patient advocacy groups, the pharmaceutical industry and others in the federal government. BIO is proud to be a partner in this initiative.
A press release from the Reagan-Udall Foundation describes the online tool:
The Navigator guides patients and physicians through the complicated process often called compassionate use, beginning with assessing whether all approved therapeutic options for patients with serious or life-threatening conditions are exhausted. If no clinical trials or expanded access programs (EAPs) are available or accessible, the Navigator acts as a clearinghouse for the single-patient expanded access policies of dozens of leading biopharmaceutical companies.
While drug manufacturers are not required to grant expanded access to investigational therapies, the 21st Century Cures Act stipulates public availability of expanded access policies and contact information. Those publicly disclosed policies must include links or references to applicable expanded access clinical trial records on the National Institutes of Health’s website and the Navigator includes a downloadable user guide for that resource.
Companies may comply with the 21st Century Cures Act’s requirements to make their expanded access policy publicly available by listing it with the Expanded Access Navigator.