2013-23019. Fibromyalgia Public Meeting on Patient-Focused Drug Development

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of public meeting; request for comments.

SUMMARY:

The Food and Drug Administration (FDA) is announcing a public meeting and an opportunity for public comment on Patient-Focused Drug Development for fibromyalgia. Patient-Focused Drug Development is part of FDA's performance commitments in the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). The public meeting is intended to allow FDA to obtain patients' perspectives on the impact of fibromyalgia on daily life as well as the available therapies for fibromyalgia.

DATES:

The public meeting will be held on December 10, 2013, from 1 p.m. to 5 p.m. Registration to attend the meeting must be received by November 27, 2013. See the SUPPLEMENTARY INFORMATION section for information on how to register for the meeting. Submit electronic or written comments by February 10, 2013.

ADDRESSES:

The meeting will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, in Section A of the Great Room (Rm. 1503), Silver Spring, MD 20993. Entrance for the public meeting participants is through Building 1, where routine security check procedures will be performed. For more information on parking and security procedures, please refer to http://www.fda.gov/​AboutFDA/​WorkingatFDA/​BuildingsandFacilities/​WhiteOakCampusInformation/​ucm241740.htm.

Submit electronic comments to www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document.

FDA will post the agenda approximately 5 days before the meeting at: http://www.fda.gov/​ForIndustry/​UserFees/​PrescriptionDrugUserFee/​ucm363203.htm.

FOR FURTHER INFORMATION CONTACT:

Graham Thompson, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1199, Silver Spring, MD 20993, 301-796-5003, FAX: [phone], email: [e-mail].

SUPPLEMENTARY INFORMATION:

I. Background on Patient-Focused Drug Development

FDA has selected fibromyalgia as the focus of a meeting under Patient-Focused Drug Development, an initiative that involves obtaining a better understanding of patients' perspectives on the severity of the disease and the available therapies for the condition. Patient-Focused Drug Development is being conducted to fulfill FDA's performance commitments made as part of the authorization of PDUFA V under Title I of the Food and Drug Safety and Innovation Act (FDASIA) (Pub. L. 112-144). The full set of performance commitments is available on the FDA Web site at http://www.fda.gov/​downloads/​forindustry/​userfees/​prescriptiondruguserfee/​ucm270412.pdf.

FDA has committed to obtain the patient perspective in twenty disease areas during the course of PDUFA V. For each disease area, the Agency will conduct a public meeting to discuss the disease and its impact on patients' daily lives, the types of treatment benefit that matter most to patients, and patients' perspectives on the adequacy of the available therapies. These meetings will include participation of FDA review divisions, the relevant patient community, and other interested stakeholders.

On April 11, 2013, FDA published a notice (78 FR 08441) in the Federal Register announcing the disease areas for meetings in fiscal years (FY) 2013-2015, the first 3 years of the 5-year PDUFA V timeframe. To develop the list of disease areas, the Agency used several criteria that were outlined in the April 11 notice. The Agency obtained public comment on these criteria and potential disease areas through a notice for public comment published in the Federal Register on September 24, 2012 (77 FR 23454, and through a public meeting held on October 25, 2012. In selecting the disease areas, FDA carefully considered the public comments received and the perspectives of its review divisions. By the end of FY 2015, FDA will initiate another public process for determining the disease areas for FY 2016-2017. More information, including the list of disease areas and a general schedule of meetings, is posted on FDA's Web site at http://www.fda.gov/​ForIndustry/​UserFees/​PrescriptionDrugUserFee/​ucm326192.htm.

II. Public Meeting Information

A. Purpose and Scope of the Meeting

As part of Patient-Focused Drug Development, FDA will obtain patient and patient stakeholder input on symptoms of fibromyalgia that matter most to patients and on current approaches to treating fibromyalgia. Fibromyalgia is a chronic disorder characterized by widespread musculoskeletal pain and tenderness in multiple tender points and may be accompanied by fatigue, sleep disturbances, irritable bowel syndrome, headache, and mood disorders. While there is currently no definitive cure, treatments for fibromyalgia include medications and lifestyle changes with emphasis on minimizing symptoms and improving general health and daily function. FDA is interested in obtaining a better understanding of fibromyalgia patients' perspectives on the severity of the disease and the available therapies used to treat fibromyalgia and its symptoms.

The questions that will be asked of patients and patient stakeholders at the meeting are listed in this section, organized by topic. For each topic, a brief patient panel discussion will begin the dialogue, followed by a facilitated discussion inviting comments from other patient and patient stakeholder participants. In addition to input generated through this public meeting, FDA is interested in receiving patient input addressing these questions through written comments that can be submitted to the public docket (see ADDRESSES).

Topic 1: Disease Symptoms and Daily Impacts That Matter Most to Patients

(1) Of all the symptoms that you experience because of your condition, which 1-3 symptoms have the most significant impact on your life? (Examples may include chronic pain, fatigue, difficulty concentrating, sleep disorders, etc.)

(2) 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, driving, household chores, etc.)

(a) How do your symptoms and their negative impacts affect your daily life on the best days? On the worst days?

(3) How have your condition and its symptoms changed over time?

(a) Do your symptoms come and go? If so, do you know of anything that makes your symptoms better? Worse?

(4) What worries you most about your condition?

Topic 2: Patients' Perspectives on Current Approaches to Treating Fibromyalgia

(1) What are you currently doing to help treat your condition or its symptoms? (Examples may include prescription medicines, over-the-counter products, and other therapies including non-drug therapies such as exercise or acupuncture)

(a) What specific symptoms do your treatments address?

(b) How has your treatment regimen changed over time, and why?

(2) How well does your current treatment regimen treat the most significant symptoms of your disease?

(a) How well do these treatments improve your ability to do specific activities that are important to you in your daily life?

(b) How well have these treatments worked for you as your condition has changed over time?

(3) What are the most significant downsides to your current treatments, and how do they affect your daily life? (Examples of downsides may include bothersome side effects, going to the hospital for treatment, restrictions on driving, etc.)

(4) What specific things would you look for in an ideal treatment for your condition?

B. Meeting Attendance and/or Participation

If you wish to attend this meeting, visit https://patientfocusedfibromyalgia.eventbrite.com. Please register by November 27, 2013. Those who are unable to attend the meeting in person can register to view a live webcast of the meeting. You will be asked to indicate in your registration whether you plan to attend in person or via the webcast. Your registration should also contain your complete contact information, including name, title, affiliation, address, email address, and phone number.

Seating will be limited, so early registration is recommended. Registration is free and will be on a first-come, first-served basis. However, FDA may limit the number of participants from each organization based on space limitations. Registrants will receive confirmation once they have been accepted. Onsite registration on the day of the meeting will be based on space availability. If you need special accommodations because of disability, please contact Graham Thompson (see FOR FURTHER INFORMATION CONTACT) at least 7 days before the meeting.

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 will also be asked to send a brief summary of responses to the topic questions to [e-mail]. Panelists will be notified of their selection soon after the close of registration on November 27, 2013. FDA will try to accommodate all patients and patient stakeholders who wish to speak, either through the panel discussion or audience participation; however, the duration of comments may be limited by time constraints.

Interested members of the public, including those who attend the meeting in person or through the webcast, are invited to provide electronic or written responses to the questions pertaining to Topics 1 and 2 to the public docket (see ADDRESSES). Comments may be submitted until February 10, 2013.

Dated: September 17, 2013.

Leslie Kux,

Assistant Commissioner for Policy.