By Vicki G. Norton and Sandra Stoneman
With Congress’s recent passage of the 21st Century Cures Act (the “Cures Act”) by an overwhelming majority, and President Obama’s anticipated signing of the bill, we expect that the Cures Act will soon become law. The Cures Act is intended to accelerate development and FDA approval of medical innovations such as cancer treatments, precision medicine and regenerative medicine.
The Cures Act also is designed to provide easier patient access to experimental therapies on a “compassionate use” or “expanded access” basis in response to patient demand for easier access to these therapies before they are FDA-approved. Companies engaged in clinical trials will need to adopt corporate expanded access policies and make them publicly available within the deadlines set by the Cures Act (described below).
If you have any questions about how to develop, implement or manage an expanded access policy or how any other aspect of the Cures Act will impact your company, please contact Vicki Norton, Sandra Stoneman, or any other member of the Duane Morris Life Sciences practice group. Continue reading “Alert: Drug and Device Developers Should Be Aware of the Expanded Access Policy Requirement under the 21st Century Cures Act.”