In Monday’s edition of the Pink Sheet, Ellen Sigal, Chair and Founder of Friends, was quoted on the recent Friends proposal to reorganize the FDA into a more disease-oriented structure.
Quoting Dr. Sigal’s recent Op-Ed in The Hill, the article outlined the issues with FDA’s current structure. “Congress has not modernized FDA’s organizational structure for medical products since the 1970s…The existing regulatory framework has been defined by a ‘divide and conquer’ approach to oversight; separate centers within FDA regulate three major categories of medical products: drugs, devices and biologics.'”
The article offered Friends’ vision for a solution, noting that organizing teams of experts based on their expertise in specific disease areas “The agency can improve coordination within and between FDA medical product centers and ensure that the regulation of products is more reflective of how they are used in medical practice. This approach will break down decades’ old silos within the agency.”
Read the full article below.