The U.S. Food and Drug Administration (FDA) recently announced new changes to expand and update the Expanded Access (EA) program, which allows very ill patients access to experimental treatments outside of clinical trials. The most recent updates include:
- Clarifications on Safety Data: The FDA clarified how it uses safety data on investigational drugs or biologics used during the EA process to address companies’ concern that EA-related adverse events could be used in ways that complicate the review process.
- New Navigation Team: The FDA is creating a new Patient Affairs Staff and Health-Care Provider Affairs Program to serve as the “primary point of entry” for the EA program to help physicians and patients navigate the EA process.
- New Coordinating Committee: The new Expanded Access Coordinating Committee will facilitate communication across the FDA and promote consistency and best practices.
- Updated Web Resources: In addition, the FDA is updating its EA webpages to improve usability and add new pages with commonly requested information. A new webpage has also been developed to help patients understand the new Right to Try pathway.
The FDA previously announced two other changes to the EA program to streamline documentation for expanded access requests and simplify the institutional review board (IRB) review to permit just one IRB member to concur with treatment use rather than the entire Board.
Many of these changes are the result of an independent assessment of the EA program, which looked at the performance of the program, including perspectives from a variety of stakeholders.
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