Theresa Mullin, the director of Strategic Programs for the Food and Drug Administration (FDA), issued a statement on FDA Voice detailing the Patient-Focused Drug Development (PFDD) program and inviting patient organizations to participate.
The PFDD program consists of public meetings that allow patients, caregivers and families to detail their experiences with certain diseases including cancer, sickle cell anemia and fibromyalgia. Mullin states that information and experiences provided by patients allow the FDA to make more informed decisions in relation to regulation of drugs and treatment options in development.
With this in mind, Mullin invites patient organizations to help expand the PFDD model and to lead it externally from the FDA. PFDD meetings will be taking place for organ transplant patients, sarcopenia, neuropathic pain related to peripheral neuropathy, autism, alopecia areata and hereditary angioedema within the 2016 and 2017 fiscal year.
Patient organizations that intend to carry out these kinds of meetings are encouraged to submit a letter of intent. The FDA does not guarantee that it will be present or participate in external meetings, though Mullin notes that FDA participation is possible for well-organized events.
Mullin also states that meetings outside of the PFDD program are neither sponsored nor endorsed by the FDA.
