The Role of Patient Advocates and the FDA Deborah J. Miller, Ph.D., M.P.H., R.N. Office of Special Health Issues
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1 The Role of Patient Advocates and the FDA Deborah J. Miller, Ph.D., M.P.H., R.N. Office of Special Health Issues Ovarian Cancer National Alliance 15 th Annual Conference July 16, 2012
2 Outline Brief history of the Office of Special Health Issues (OSHI) OSHI s activities Patient and Patient Advocacy Input to FDA Patient Representative Program Patient Network Program 2
3 Before FDA had a history and tradition of careful review, and a conservative approach to balancing potential risks and benefits of drugs. Activists showed that they needed, and were willing, to take more chances with risks associated with new therapies... 3
4 October
5 After FDA responded by seeking ways to speed review time and access to promising therapies without jeopardizing patient safety or compromising scientific rigor, and creating OSHI 5
6 OSHI... works with patients and patient advocates to encourage and support their active participation in FDA decision-making and policy formulation. 6
7 Brief Highlights of OSHI s History 1988 Established Office for HIV/AIDS Advocates 1991 Initiated Patient Representative Program for HIV/AIDS 1994 Added other High Profile Special Health Issues 2001 Established Patient Consultant Program 2006 Established Health Professional Liaison Program 2008 Added MedWatch Program 7
8 OSHI Activities Represent patient and healthcare professional concerns Manage o Patient Representative Program o Patient Network o Health Professional Liaison Program o MedWatch Program Coordinate outreach and educational activities with health professional organizations and patient advocacy groups Respond to and phone inquiries 8
9 Patient and Patient Advocate Participation Patient Representative Program o Speak at open public hearings o Serve as patient representative on advisory committee panel o Serve as patient consultant for FDA review divisions in clinical trail and post trial review phases Public Meetings Public comment on proposed rules and policies Workshops 9
10 Patient and Patient Advocate Participation (cont.) Request a meeting (OSHI) Direct communications (e.g., , telephone) Community meetings Citizen s Petition 10 10
11 Patient Representative Program Who are Patient Representatives? Patients Patient Advocacy Groups members Community Advocacy Groups members Family and/or caretakers Health Care Providers 11
12 FDA includes Patient Representatives on advisory committee panels that review products and therapies related to serious and life-threatening diseases on a case-by-case basis. These have included: AIDS/HIV Alzheimer s Disease Asthma/COPD Cancer Cardiovascular Disease Cerebral Palsy Chronic pain Crohn's Disease Depression Diabetes Fibromyalgia Hepatitis B Hepatitis C Irritable Bowel Syndrome Lung Transplantation Lupus Macular Degeneration Major Depressive Disorder MRSA Neuropathy Obesity/Weight Control Parkinson's Disease Polio Sickle Cell Disease Short Bowel Syndrome Temporomandibular joint (TMJ) Disorder 12
13 Patient Representative Program Incorporating patient/community advocate s voices into advisory committee discussions and furthering an understanding and appreciation for FDA s role in drug development and patient protection 13
14 Advocating with FDA Patient Representative Program The Program s Activities: Recruitment of New Patient Representatives Selection of Patient Representatives for: o Advisory Committees o Consultation with Review Division Conducts Training For Patient Representatives More information: See FDA web site under: Resources for You For Patients and Patient Advocates 14 14
15 What does FDA look for Advocating with FDA in patient representatives? Someone who brings a patient perspective, based on personal experience, to the process Have patient community awareness o Active in organizations o Participation in chat rooms, blogs, etc. o Other advocacy activities Someone who is analytical and objective o Doesn t need to be a scientist, but should grasp scientific principles and understand the issues Experience with decision making based on complex information 15
16 Preparing Representatives for Their FDA Roles Initial one-on-one orientation and training by OSHI staff Ongoing training o Monthly teleconference/webinar training Drug review processes Understanding data sets Clinical trial endpoints Statistical analyses o Annual workshop Role of advisory committees Drug safety Networking between patient representatives Best practices from patient representative experiences o Mentoring by senior patient representatives and consultants 16
17 FDA Benefits from Patient Representatives by... Involving patients from early stages of drug development when their input can have significant impact Helping patients develop the knowledge and skills to make meaningful contributions to product development based on their unique experience and perspective Integrating patient input in a meaningful way throughout the drug development life cycle 17
18 Value Provided to FDA Provide FDA with insight on issues, problems, and/or questions pertinent to the viewpoint of patients and family members living with a specific serious or lifethreatening disease. Product user perspectives the human element Point of view on Risk/Benefit Quality of life adverse events Patient input on labeling Contribution to better designed future clinical studies Inclusion of women and ethnic populations Community Ambassadors/Educators 18
19 FDA Patient Network Program - Objectives The FDA Patient Network will: educate and inform patient stakeholders about the FDA, its regulatory authorities and processes, its initiatives and programs, etc.; and, provide a venue for advocacy for patient stakeholders within the FDA and be transparent to patients about agency actions. 19
20 FDA Patient Network Program - Audiences The FDA Patient Network seeks to engage external patient stakeholders, including: individual patients, caregivers, and patient advocates; disease-specific and broad patient advocacy organizations; and, special population organizations that have a health component (i.e. minority groups, pediatric groups). 20
21 FDA Patient Network Program Activities The core activities of the FDA Patient Network include: web site, including educational modules, centralized relevant agency information, and multi-directional communication tools (coming soon); annual meeting (first meeting held on May 18, 2012, FDA Working with Patients to Explore Benefit/Risk: Opportunities & Challenges htm); newsletter (started in March To sign up, go to: SFDA_203); and, periodic listening sessions/briefings. 21
22 Advocating with FDA Other channels for advocating Working directly with industry Convening broad-based meetings to address barriers o Patients o Clinicians o Industry o Research enterprise/academia o FDA 22
23 Facts to keep in mind when Advocating with FDA advocating at FDA FDA works within a relatively tight regulatory framework Can encourage and guide sponsors, but does not have jurisdiction/authority to direct research and development FDA provides expert technical assistance to facilitate new drug development, but doesn t have control FDA doesn t have all the answers, or solutions FDA operates under strict confidentiality rules concerning proprietary information related to product development 23
24 Preparation is of utmost importance Organize arguments and data o FDA is an evidence-based, data driven regulatory agency o Come prepared to lay out and support requests and arguments Work with us to organize/strategize 24
25 White Oak, Bldg New Hampshire Ave. Silver Spring, MD
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