Essential Compliance in Expanded Access

Beyond the need for compliance with 21st Century Cures legislation, your company Policy on Expanded Access needs to clearly articulate the criteria for consideration of a request, patient criteria, physician qualifications, the process and the length of time the manufacturer anticipates will be necessary to acknowledge receipt of requests. The legislative driver for a corporate policy on Expanded Access requires new focus on a previously unattended area. It is incumbent upon organizations that support a strong quality culture to develop a process that will enable the policy to be executed with minimal disruption to the clinical research environment.

Standard Operating Procedures (SOPs) provide your personnel with the steps required to receive, process and execute a request for Expanded Access to an investigational drug in your pipeline. More importantly, the SOP will equip specific roles to efficiently manage a request when it is received. If your company does not have an SOP that explicitly covers the management of expanded access requests, it is likely that each request is handled differently, resulting in an inefficient process and critical delays for the waiting patient. It is not uncommon for teams to receive requests infrequently, often weeks or months between requests. An SOP will equip your resources with the tools they need to manage requests more efficiently and provide role clarity for various stakeholders. Optimal management of requests is especially important in a globally based pharmaceutical company where regionally-based stakeholders are critical elements in the decision and process of request management. Well-designed SOPs with multiple stakeholder engagement, enable teams to focus their efforts on making the best decision on the request itself, rather than formulating options on how to manage the request without delay. The patient is waiting, but it shouldn’t be for a company to figure out which path to follow.

Early Access Care helps pharmaceutical companies align and develop policies and SOPs that optimize the request process within the construct of a US-only or global organization. Our solutions-driven team will design and deliver a custom Policy and SOP that will enable compliance with 21st Century Cures legislation and regulatory audits. For more information contact info@earlyaccesscare.com.