What Is Wrong With Peter A. Schneider Current Regulation of - PowerPoint PPT Presentation

4/18/2013 Disclosure What Is Wrong With Peter A. Schneider Current Regulation of Potential conflicts of interest to report: Vascular Devices By the FDA? Consultant to start-ups: Silk Road, Altura, Revascular, Intact Vascular, Pro-med Peter A. Schneider, MD Enter patients in studies: Abbott, Gore, Medtronic, Cordis Hawaii Permanente Medical Group and Kaiser Foundation Hospital Modest royalty from Cook Honolulu, Hawaii UCSF Vascular Symposium April, 2013 Current Regulation of Vascular Devices Current Regulation of Vascular Devices Perspective • Vascular is a device-dependent endeavor • Safety-”do no harm”, safety concerns are ingrained into modern medical practice, risk aversion • Innovation-at some point, innovation forces us to change how we do things, how will we know if that is safe enough? Endovascular Today March, 2013 1

4/18/2013 What Does the FDA Regulate? FDA Foods safety of all food products, labeling, bottled water, food additives, infant formulas Dietary Supplements Human Drugs • 14,648 Employees product approvals, OTC and prescription drug labeling, drug manufacturing standards Vaccines, Blood Products, and Other Biologics – Margaret Hamburg, MD FDA Commissioner product and manufacturing establishment licensing, safety of the nation's blood supply • 2013 budget-$4.4B research to establish product standards and develop improved testing methods 25% of the US economy Medical Devices – FDA Justification of Estimates for Appropriations Committees, 670 pg from simple items like tongue depressors, to complex technologies such as heart pacemakers premarket approval of new devices, manufacturing and performance standards – Budget for 2000 was $1.3B tracking reports of device malfunctioning and serious adverse reactions • 8 Divisions Electronic Products products that give off radiation, such as microwave ovens and X-ray equipment • Center for Devices and Radiological Health radiation safety performance standards for microwave ovens, television receivers, diagnostic x-ray equipment, cabinet x-ray systems (such as baggage x-rays at airports), laser products, – Jeffery Shuren, MD ultrasonic therapy equipment, mercury vapor lamps, and sunlamps accrediting and inspecting mammography facilities Cosmetics – 1,413 Employees Safety, labeling Veterinary Products livestock feeds, pet foods, veterinary drugs and devices Tobacco Products Forbes, 2012 Current Regulation of Vascular Devices What Is Right With the System? CDRH Mission • Significant resources have been devoted Get safe and Get safe and • Recent efforts to clarify pathways effective medical effective medical devices to market devices to market • Innovation approval pathway as quickly as as quickly as • New teaching materials possible… possible… … while ensuring … while ensuring • Entrepreneur in residence program that medical that medical devices currently • Safety is being achieved devices currently on the market on the market – 99.6% of 510(k) and PMA devices did not remain safe and remain safe and experience a recall in last 5 years effective. effective. – Hall R. Using recall data to assess the effectiveness of the FDA clearance process. Institute of Medicine, Washington DC, July, 2010. Help the public get science-based accurate information about Help the public get science-based accurate information about medical devices and radiological products needed to improve health. medical devices and radiological products needed to improve health. Bill Sutton: Overview of Regulatory Requirements for Medical Devices 2

4/18/2013 Define Terms Current Regulation of Vascular Devices Device Classifications • 510(K): Statute provides for approval of a device that is substantially equivalent to already approved device. • IDE: Granted to study unapproved significant risk device in Type I- Type II- Type III- human subjects. Typically involves first-in-man data from Low Risk Medium Risk High Risk OUS and preclinical data. Must obtain prior to PMA. • PMA: Premarket approval of device (513(k)), requires Bandages Angioplasty balloon Stent clinical trial. Exam gloves Blood pressure kit Pacemaker • MDUFA: Medical Device User Fee Amendments (2007) Wheel chairs Fixation screw Heart valve Catheter Dental laser • GLP and GCP: Good Laboratory Practices, governs Infusion pump Total joint preclinical studies, Good Clinical Practices: clinical trials. • FDA panel: Convened to review clinical study data. Usually exempt: Typically through Typically through • Post-approval Study: Mandated for selected Class III Must register 510(k) premarket premarket approval devices. device with FDA notification process (PMA) • Post-market Surveillance-ongoing registry to monitor safety submission <10% of cases and effectiveness of Class II and III devices sold in US. Current Regulation of Vascular Devices Current Regulation of Vascular Devices Current Approval Pathways Disadvantages of the System • 510(k) – Requires a predicate: “substantial equivalence” • Layered and nuanced – FDA has 90 days to review • Not predictable – Takes about a year • Expensive – 510(k) with clinical data – 510(k) de novo • Time consuming • PMA • Created an industry – All Class III devices • Difference between request and reality – FDA has 180 days to review – Are the requests rooted in real risk reduction? – Develop clinical trial, get approval from FDA, prepare and submit PMA – Are the requests reasonable? – No usual timeframe, minimum of 36 months 3

4/18/2013 Current Regulation of Vascular Devices 5 New Obamacare Taxes Coming in 2013 TIME Dec 7, 2012 US Medical Device Industry Manufactures and importers of certain medical devices will be taxed 2.3% of the price of the product. Devices will not include retail objects • 1023 public and privately backed like corrective lenses or hearing aids, but will companies include products like defibrillators, pacemakers, artificial joints, stents, and those involved in • More than half are in CA, MN, MA cancer treatments, angioplasty and vascular surgery. More than 800 companies from the • 98% of companies have <500 employees powerful medical device industry have protested the tax, which will raise $1.8 billion next year, and $20 billion over the next seven 2007 2012 years. Companies 116 $720M 2.3% excise tax is on total revenues, not profits Amount raised 55 $200M Lower costs by shifting manufacturing OUS? Ernst and Young, Pulse of the Industry Medical Technology Report, 2010 PriceWaterhouseCoopers, 2012 Current Regulation of Vascular Devices What Does Device Industry Say? • 44% experienced change of key FDA personnel during approval process (either the review staff or section chief or both). • 34% indicated that appropriate FDA personnel not present at scheduled meetings. • >90% believe that FDA has become more risk averse in last decade. • 66% indicated that these issues negatively impacted the progress of the company. Meer and Makower, Nov. 2010 FDA Impact on US Medical Technology Innovation Meer and Makower, Nov. 2010 4

4/18/2013 Current Regulation of Vascular Devices Chart 5. Percentage of 510(k)s With Additional Information (AI) Request on 1st FDA Review Cycle *10 months FDA Annual Report 2012 Meer and Makower, Nov. 2010 Companies rated regulatory bodies on basis of: clinical competence, engineering competence, statistical competence, predictability, transparency and reasonableness. Meer and Makower, Nov. 2010 Meer and Makower, Nov. 2010 5

4/18/2013 Meer and Makower, Nov. 2010 Meer and Makower, Nov. 2010 Current Regulation of Vascular Devices Current Regulation of Vascular Devices Clinical Trials More Layers to Consider • Trial set up, manufacturing, travel, data • Valley of death=lack of funding capture, CRO, procedure, core labs, follow-up studies, visits, data analysis. • No IPOs Total Cost: FDA- • Most VCs are not currently funding Concept to dependent anything requiring a PMA Approval costs • More companies considering an OUS only 510 (k) $31M $24M strategy Pathway PMA $94 M $75M Pathway Meer and Makower, Nov. 2010 6

4/18/2013 Tools We Use-Specific Examples What is FDA doing to improve? • Early Feasibility Study Guidance • No first-in-man studies in US. Document: Get an earlier IDE with less • Minimum of 2-3 year lag between US and EU. clinical data • Drug coated balloons: In EU since 2007. • Innovation Pathway: shorten time to • AAA: 10 years from first report to approval approval of novel devices by requiring less • Carotid stent: 10 years to limited approval pre-clinical and clinical testing, placing FDA personnel and innovators on same • Percutaneous aortic valve: CE mark 2007, team approval 11/11 with >1000 patient most market study, $2B in development. • Entrepreneurs in Residence What is FDA doing to improve? Conclusion • The FDA has a huge job on its hands. • Stream line Clinical trials • It takes about 10 years for any significant • Streamline FDA approval to CMS development to make it to clinical use. coverage pathway • Device regulation is pushing the • Balance Premarket and Postmarket development industry OUS. studies • As the reimbursement decreases, many companies will take an OUS-only approach. • The FDA is taking steps to improve the process. 7