FDA's Patient Representative Program, PowerPoint Presentation
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FDA's Patient Representative Program, PowerPoint Presentation
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FDA's Patient Representative ProgramSM Salina Miller, M.S., M.B.A. Manager, FDA Patient Representative ProgramSM Advisory Committee Oversightand Management Staff Office of the Commissioner FDA Public Workshop: Partners in Progress 2018 Cancer Patient Advocates and FDA November 27, 2018 FDA Patient Representative Program Agenda I II III IV V Background What is the FDA Patient Rep P rogram? Activities Criteria and Recruitment Q&A 2 2 FDA Patient Representative Program https://www.fda.gov/ForPatients/PatientEngagement 3 FDA Patient Representative Program How did it all start? � Late 1980s: HIV/AIDS crisis. � Patients wanted a more active role in FDA regulation of medical products. � First Patient Representative Serves: Antiviral Drugs Advisory Committee, Feb. 13-14, 1991. � 1991: FDA Patient Representative Program formed. 4 FDA Patient Representative Program What is the FDA Patient Representative Program? Mechanism for advocates (patients and caregivers) to provide formal input to the Agency's decision-making process as medical products (drugs, biologics, and medical devices) are regulated. Special (or Regular) Government Employees 5 FDA Patient Representative Program Two Primary Ways for Engaging with FDA 1. Serve on Advisory Committees (panel members) 2. Consult with Review Divisions (consultations) 6 FDA Patient Representative Program Serve on Advisory Committees � A panel of outside experts convened periodically to advise the FDA on safety and efficacy issues about regulated medical products. � 31 Advisory Committees; Medical Devices Advisory Committee (18 panels) � Committee members include: � Chair � Medical Experts � Consumer Representative � Industry Representative � Patient Representative 7 FDA Patient Representative Program Consult with Review Divisions � Brings the patient voice earlier in the regulatory process. � "Homework" assignments. � Consult directly with scientific review staff and sponsors � Closed meeting (telecon) 8 Experiences Represented 200 FDA Patient Representatives 300-500 diseases/conditions/device experiences � AIDS/HIV � Alzheimer's Disease � Asthma � Cancer (various) � Cardiovascular disease � Cerebral Palsy � Crohn's disease � Cystic Fibrosis � Duchenne Muscular Dystrophy � Diabetes � Diabetes (insulin pumps) � Fabry Disease � Hepatitis B � Hepatitis C � Infantile Spasms � Lung Transplantation � Lupus � Lysosomal Acid Lipase Deficiency � Major Depressive Disorder � Muscular Dystrophy � Obesity/Weight Control � Opioid Use � Parkinson's Disease � Pompe Disease � Sickle Cell Disease � Short Bowel Syndrome � Temporomandibular joint disorder � Transplantation 9 FDA Patient Representative Program How Do We Recruit? � National Patient Advocacy Organizations � Regional or Local Organizations � Health Care Providers � FDA Centers and Divisions � Agency-Sponsored Meetings and Activities (work with PAS) � Self-Nominations � FDA Patient Representatives � Web, Email, Social Media 10 Building Relationships With Rare Disease Communities 11 11 FDA Patient Representative Program What CRITERIA Do We Use? � Personal experience with the disease or condition, either as a patient or primary caregiver. � Patient community awareness: active with patient advocacy organizations. � Knowledgeable about treatment options and research. � Someone who is analytical and objective, doesn't need to be a scientist but should grasp scientific principles and understand issues, experienced with decision making based upon complex information. � Good communications skills. � Commitment to serve. � Minimal or no financial or ethical conflicts of interest. 12 FDA Patient Representative Program We Train and Prepare!!! � Describe significance of program � Describe FDA regulatory framework and decisionmaking process (FDA 101) � Share experiences: internal and peer � Describe scenarios for the meeting � Provide online resources for patients � Share agency activities 13 FDA Patient Representative Program Areas of Input Provides 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. Clinical Trial Design Entry Criteria Endpoints Drug Toxicity Issues Quality of Life Issues Adverse Events Study Recruitment (diversity, etc.) Informed Consent Expanded Access Product Labeling Risk/Benefit 14 FDA Patient Representative Program As a result... � Patients and caregivers having an active role on FDA Advisory Committees and in consultations with review divisions. � Patient voice represented in important discussions about regulatory decision-making. � Furthers an understanding and appreciation for FDA's role in medical product development, review and patient protection. � Presence at the table. 15 FDA Patient Representative Program To help protect your privacy, PowerPoint has blocked automatic download of this picture. THANK YOU!! Salina Miller, MS, MBA Manager, FDA Patient Representative Program salina.miller@fda.hhs.gov https://www.fda.gov/ForPatients/PatientEngagement/ 1616