The 17 March 2016 public meeting at the US Food and Drug Administration (FDA) will allow for patients to offer their unique perspectives on the impact of psoriasis, including on daily life and treatment options.
FDA says it’s interested in “patients’ perspectives for the types of psoriasis with primarily skin symptoms (such plaque psoriasis, nail psoriasis, guttate psoriasis, etc.), patient views on treatment approaches, and decision factors taken into account when selecting a treatment.”
The call for public comment and a meeting on psoriasis on Tuesday is one of about 17 meetings and requests for more information FDA has conducted under its patient-focused drug development program from the fifth authorization of the Prescription Drug User Fee Act (PDUFA V).
FDA committed to obtain the patient perspective on at least 20 disease areas during the course of PDUFA V, including ones on breast cancer, Chagas disease, female sexual dysfunction and Parkinson’s and Huntingdon’s diseases.
On the topic of the immune-mediated skin condition psoriasis, the agency is interested in the perspectives of patients with psoriasis on (1) the impact of their skin disease, including the extent and location (e.g., nail, palm, scalp, genital) (2) treatment approaches, and (3) decision factors taken into account when selecting a treatment.
“While there is currently no cure, treatments for psoriasis include topical therapies such as corticosteroids and vitamin D, analogs, systemic drugs, biologic products, and phototherapy,” FDA says.
The agency also lays out a series of questions for patients to weigh in on, including:
- How well do your treatments address specific skin symptoms? Which symptoms are not addressed as well?
- Are there specific activities that are important to you but that you cannot do at all or as fully as you would like because of your condition? (Examples of activities may include sleeping through the night, daily hygiene, participation in sports or social activities, intimacy with a spouse or partner, etc.)
- What would you consider to be a meaningful improvement (for example symptom improvements or functional improvements) in your condition that a treatment could provide?
Patients who are interested in presenting comments as part of the initial panel discussions will be asked to indicate in their registration which topic(s) they wish to address. These patients also must send to PatientFocused@fda.hhs.gov a brief summary of responses to the topic questions by 29 February 2016. Panelists will be notified of their selection approximately seven days before the public meeting.
Federal Register Notice