The groups, the Alliance for Lupus Research (ALR), the Lupus Research Institute (LRI), the Lupus and Allied Diseases Association (LADA), and the Lupus Foundation of America (LFA), will lead the innovative initiative featuring panel debates to provide the U.S. Food and Drug Administration (FDA) with different viewpoints from advocates, lupus patients, and caregivers.
The conference will follow a model previously developed by the FDA. Focus will be placed on discussing patient perspectives about lupus; reviewing the disease’s symptoms and its impacts on patients lives; and exploring patients’ views on currently available and potential future therapies.
According to organizers, the day-long event aims better inform the FDA’s decisions and oversight for development of new drugs for Lupus and assist in the review of marketing applications for new Lupus treatments.
The four Lupus associations responded to the FDA’s call for organizations to send letters of intent for the Patient Focused Drug Development (PFDD) convention.
PFDD is a new initiative from the FDA intended to bring patient perspectives into an earlier stage of product development in order to provide context for benefit-risk assessments and input to review divisions. The FDA also hopes to utilize information to help in the development of new assessment tools, study endpoints, and risk communications.
A related effort was undertaken in 2014 by the Parent Project Muscular Dystrophy (PPMD), who lobbied for passage of the Patient-Impact Assessment Act by Congress to function as a publicly accessible measurement tool for the FDA to conduct revisions of their other resources and tools focused on patient-focused drug development.
Beginning in fall 2017, the four lupus organizations will begin gathering input from patients across the country through personal stories and surveys. At that time, information regarding patient participation in the meeting will be made available.