For too long, there has been a knowledge gap between the recovery priorities of the spinal cord injury (SCI) community and the regulators at the Food and Drug Administration (FDA).

The FDA serves as an important safety valve for the clinical implementation of research. But sometimes that valve can become a bottleneck, blocking the progress of vital therapies, drugs and devices. The FDA needs to know what research to prioritize and how they need to adapt in order to balance safety and speedy clearance of vital treatments for human use. And the first stop to gather that information is the community of lived experience. 

Patient Focused Drug Development (PFDD) is an authoritative, comprehensive process developed  by the FDA in 2012 under the Prescription Drug User Fee Act (PDUFA) to identify the treatment priorities of lived experience communities. It involves an in-depth, virtual meeting with stakeholders in the SCI community to discuss its most pressing and unmet needs. The meeting and additional information gathering will allow the FDA to create an official report, which will guide future treatment development and regulatory approval.  

This is something our community has needed for a long time and now it’s here.  This initiative has been adopted and supported by the leading SCI advocacy groups and foundations across the US. The more people we have attend the PFDD meeting, the better chance we have for a strong message of urgency to be heard and adhered to.