speakers! Jeffrey E. Shuren MD, JD Steven Immergut MPH Janet Woodcock MD Margaret Anderson Director, Center for Drug Evaluation and Research

Transcription

1 Key FDA Programs! Objective: Describe FDA initiatives at CDER and CDRH to incorporate patient perspectives in decision-making and to articulate assessment of benefit-risk in a consistent manner across divisions in each center, as well as FDA s Patient Representative Program.! 1

2 speakers! Steven Immergut MPH Jeffrey E. Shuren MD, JD Associate Commissioner Director, Center for for External Affairs, Devices and Radiologic Office of the Health Commissioner Janet Woodcock MD Margaret Anderson Director, Center for Drug Evaluation and Research Executive Director, FasterCures MODERATOR

3 CDRH s Patient Preference Initiative Jeff Shuren Director Center for Devices and Radiological Health, U.S. Food and Drug Administra?on September 23, 2014 FasterCures Benefit - Risk Boot Camp

4 CDRH Vision Pa%ents in the U.S. have access to high- quality, safe and effec%ve medical devices of public health importance first in the world. 4

5 Evolution of the Role of Patients Old School: Paternalis%c provider- pa%ent rela%onships Emerging Diseases: Pa%ent advocacy for availability of and access to new treatments The Internet: Pa%ent empowerment through informa%on The Future Today: Pa%ent preferences informing regulatory decisions and pa%ent par%cipa%on in shared decision making 5

6 Benefit-Risk Guidance March 2012 Factors to Consider for Benefit - Risk Determina?ons Medical Device Premarket Approval and De Novo Classifica?ons Pa%ent tolerance for risk and perspec%ves on benefit Risk tolerance will vary among pa8ents, and this will affect individual pa8ent decisions as to whether the risks are acceptable in exchange for a probable benefit. FDA realizes that some pa8ents are willing to take on a very high risk to achieve a small benefit, whereas others are more risk averse. Therefore, FDA would consider evidence rela8ng to pa8ents perspec8ve of what cons8tutes a meaningful benefit when if the device is effec8ve, as some set of pa8ents may value a benefit more than others. h=p:// DeviceRegulaKonandGuidance/GuidanceDocuments/UCM pdf 6

7 Patient Preference Initiative The goal of this ini%a%ve is to develop a process to elicit pa%ent views on benefit vs. risk and consider these pa%ent preferences in rela%on to a pa%ent s medical device exposure and severity of illness CDRH seeks to develop a system to measure pa%ent preferences as well as perform a rapid pulse check of pa%ent preferences for poten%al medical device interven%ons 7

8 Medical Device Development: Total Product Lifecycle (TPLC) Faster, Safer, More Cost Effective 8

9 Where can patient preferences be incorporated into the TPLC? 9

10 Decision Aid Tool Developed from Obesity Device Study Data To see full presentakon about this tool: h=ps://collaborakon.fda.gov/p2zrdpfiogj/ 10

11 Progress Pa%ent Preference Survey for Weight- Loss Devices Fall 2013 Public Workshop The Pa%ent Preference Ini%a%ve: Incorpora%ng Pa%ent Preference Informa%on into the Medical Device Regulatory Processes Collabora%on with MDIC on Pa%ent- Centeredness Benefit- Risk Assessment Project Development of Pa%ent Preference Guidance Pa%ent Engagement Advisory Commi^ee 11

12 Related Activities Medical Device Data Development Tools Device Labeling Special Popula%ons Expedited Access Pathways 12

13 Expedited Patient Access Our goal to provide earlier pa%ent access to high- quality, safe and effec%ve devices. Striking the right balance between premarket and postmarket data collec%on is an important focus of CDRH s Strategic Priori%es. Balancing Premarket and Postmarket Data Collec%on Draa Guidance Clarifies current policy on when post- approval studies at the %me of approval could be used to address premarket ques%ons for PMA devices Expedited Access PMA Draa Guidance New, voluntary program to expedite pa%ent access to PMA devices intended to address unmet medical needs 13

14 Thank You 14

15 Questions?!