IMPROVE THE U.S. MEDICAL DEVICE REGULATORY PATHWAYS

Transcription

1 IMPROVE THE U.S. MEDICAL DEVICE REGULATORY PATHWAYS Regulatory & Legislative Policy Levers WISE-AIChE Xiaochen (Denise) Liu BSBE, Bioengineer University of Toledo College of Engineering College of Medicine August 1 st, 2012

2 OSCAR PISTORIUS [1, 2]

3 OUTLINE Background Issues Alternatives Recommendations Conclusion

4 BACKGROUND Industry Progress Legislative History Industry Dynamics Current FDA Review

5 PROGRESS Then: Violin Vibrophone Now: Robotic Surgery [3, 4]

6 HISTORY OF REGULATORY LAWS 1938 Federal Food, Drug and Cosmetic Act Fraudulent devices 1976 Medical Device Amendments Hazard of legal devices 510(k) and PMA Registration and Listing with FDA Device classification 1990 Safe Medical Devices Act Postmarket surveillance Adverse Events Reporting [5, 6]

7 HISTORY OF REGULATORY LAWS 1997 FDA Modernization Act Regulate off-label use de novo process 2002 Medical Device User Fee and Modernization Act Expedite the review process 2007 FDA Amendments Act 2012 FDA Safety and Innovation Act [5, 6]

8 DEVICE CLASSIFICATION Class I: Low risk Elastic bandages Examination gloves Scalpels Class II: Moderate Infusion pumps Surgical drapes Powered wheelchair Class III: High Heart valves Implants Pacemakers

9 CURRENT FDA REVIEW PROCESS

10 REVIEW PATHWAYS 510 (k) Premarket Notification Class I & II devices Efficient Predicate devices Build upon established clinical & scientific evidence Sufficiently equivalent More devices use this route PMA Premarket Approval Class III & new devices Proof of safety and efficacy Clinical studies Investigational device exemption (IDE) needed Approval order Few devices use this [8]

11 ISSUES Regulatory Issues Legislative Issues Patient Safety Impact On Ecosystem FDA Performance

12 CHALLENGES FACED IN RUNNING A MEDICAL DEVICE BUSINESS [9]

13 510(K) & PMA DATA [8]

14 REGULATORY ISSUES Review Process Lacks Predictability, Transparency, Consistency Within CDRH Reviewer turnover Confusion of standards High workload Industry Poor quality submissions Postmarket Monitoring Jeopardize patient safety Vaginal/hernia mesh Hip and knee implants

15 LEGISLATIVE ISSUES Physicians Payment Sunshine Provision Manufacturers to report payments/benefits Over $10 each time Over $100 annually to physicians Burdensome Affordable Cares Act (2010) 2.3% Excise tax on revenue Reduce funding for innovation FDA Safety and Innovation Act (2012) MDUFA III Use the fee efficiently to improve predictability, transparency, and consistency

16 INNOVATIVE PATHWAY Innovation Early R&D FDA Review Process Market PPS ID Clinical Needs VCs ACA: 2.3% Tax Longer Review Lower Success Rate MDUFA III Safety & Efficacy Recalls Comparative Effectiveness

17 ECOSYSTEM Investor Confidence Reduced investment in high-risk devices Decreased investment in early stage R&D Industry Fewer medical device start-ups More M&A activities Companies relocate to foreign countries Healthcare Costs Time and costs of device development process will be passed on to the consumers Denied or delayed access Devices are first available in foreign markets TAVR [7]

18 MARKETING PROCESS IMPACT OF REGULATION INVESTOR INDUSTRY Regulation Tax Protection PHYSICIAN GOVERNMENT ACADEMIA Legislation Protection Funding PATIENT Votes Complaints Congress

19 FDA PERFORMANCE Met most of its performance goals in 2011 Complete 90% of 510(k) reviews within 90 days or less but 90 FDA days Recalls Also categorized with classes Class I: devices present significant consequences Class II: devices present remote risk Class III: devices present minimal risk From , 99.5% of all 510(k) and PMA devices cleared/approved never had a Class I recall Less than 9% of the Class I recalls involve possible undiscovered clinical risks

20 ALTERNATIVES Foreign Countries IOM Independent Study Changes in Place

21 ALTERNATIVES JPN EU US [11, 12, 13]

22 ALTERNATIVES Institute of Medicine (IOM) Consolidate the terms indication for use and intended use into a single term, intended use Expand its statutory authority to consider off-label use when determining the intended use of a device Issue guidance on when a device should no longer be available for use as a predicate Issue guidance to create a Class IIb Seek greater authorities to require postmarket surveillance studies as a condition of clearance for certain devices [14]

23 CHANGES IN PLACE Unique Device Identifier (UDI) Enhance Communication & Transparency Innovation Pathway 2.0 Guidance & Standard Operating Procedures Entrepreneur-in-Residence Mandatory Reviewer Certification Experiential Learning Program Hire 140 full-time device reviewers Streamline the review process

24 RECOMMENDATION Regulatory Process Legislation

25 RECOMMENDATION Reevaluation of devices cleared with recalled predicates National Registry One registry for each of the 16 panels Review Device Performance Annually Conducted by Physicians & Surgeons Sunshine Acts Manage conflicts of interest in every sector involved in the device industry Physicians, Politicians, Academia Transparency for payment/benefit over $100,000 annually

26 CONCLUSION The U.S. medical device regulation system Not perfect Needs improvements Best one there are Regulatory policies have broad impact Funding & Investing Identifying clinical needs Review time & costs Solutions Procedural Legislative

27 REFERENCES [1] Oscar Pistorius Official Website. [2] Ossur Cheetah. [3] Industrial Anatomy, Violin Vibrophone, 04/03/13/ [4] Da Vinci Surgery: Minimally Invasive, [5] CRS Report R42130, FDA Regulation of Medical Devices, by Judith A. Johnson [6] CRS Report RL32826, The Medical Device Approval Process and Related Legislative Issues, by Erin D. Williams. [7] Exvere Inc., Medical Device Manufacturing Market Update, 2011, [8] FDA Impact on U.S. Medical Technology Innovation: A Survey of Over 200 Medical Technology Companies, Josh Makower, Aabed Meer, and Lyn Denend. November Independent data analysis and verification by PricewaterhouseCooper LLP. [9] Emergo Group, 2012 Medical Device Industry Survey, [10] New York Times, Johnson & Johnson Recalls Hip Implants,

28 REFERENCES [11] Medical Device Certification, Basic Information about the European Directive 93/42/EEC on Medical Devices, [12] Morgan Lewis-TMI, An Overview of Pharmaceutical and Medical Device Regulation in Japan, Satoru Nagasaka, Benjamin Lang, Mihoko Shintani, and Sayaka Ueno, [13] U.S. Department of Commerce Office of Health and Consumer Goods, China medical Device Registration, Jay Biggs, 2004, [14] FDA, 510(k) and Science Report Recommendations: Summary and Overview of Comments and Next Steps, UCM pdf

29 ACKNOWLEDGEMENT Dean Nagi Naganathan UT BIOE Professors Dr. Josh Mackower Mr. Mark Leahey Dr. Tomoko Steen Dr. David Lipson Dr. Haggard Fellow WISE Interns Dr. Rose Wesson Steve Smith Erica Wissolik Melissa Carl Bill Behn Stanley Liu Ms. Ellsworth Glenn Ruskin Parents: Dr. Jiayong Liu & Qin Wang

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