Key CDRH Regulatory Initiatives

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Patience Perkins
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1 Key CDRH Regulatory Initiatives Revamping the Submission Process Creating New Strategies Ralph F. Hall University of Minnesota Law School Counsel Faegre Baker & Daniels May 8, 2012

2 Purpose of Today s Program Review Key CDRH Initiatives - Focus on submission related guidance - Enable proactive regulatory strategies Identify key issues - Major risks and benefits - Hidden issues Identify new strategic approaches - New guidances spawn new strategies 2

3 Agenda Background New clinical trial guidances New 510(k) program Risk benefit guidance Modifications 522 orders and Post market Conclusion 3

4 How Did We Get Here? 4

5 2008 Rising Concerns About FDA End of Bush administration FDA under siege ReGen controversy Whistleblower letter Series of product issues Health care cost and reform New administration Pressure from key physician groups Loss of public credibility 5

6 2009 CDRH 510(k) Initiatives Internal assessments and work plans Several key reports Engagement of IOM Two key questions: safety and innovation Seven subsequent detailed questions 18 month process 2011 FDA work plan 25 items or categories Many initiatives in process 6

7 IOM Report Summary IOM proposes eliminating the 510(k) system IOM declined to address innovation question One of two original questions IOM recommended creating a commission to study innovation IOM declined to address 7 contentious 510(k) issues Insufficient time Some addressed indirectly However, the report said more than just junk the 510(k) system Improve post market Software regulation Internal FDA processes 7

Medical Innovation Ecosystem Ideas $ $ Fuelers -- Venture Capital -- Private Investors $ $ Third Party Payers -- Government -- Private Payers Innovators Products Regulators -- US: FDA -- EU: CE

8 Medical Innovation Ecosystem Ideas $ $ Fuelers -- Venture Capital -- Private Investors $ $ Third Party Payers -- Government -- Private Payers Innovators Products Regulators -- US: FDA -- EU: CE System Consumers: --Patients --Providers Needs Modified from: Josh Makower, MD, The Structure of the MedTech Innovation Ecosystem, Presentation at Public Health Effectiveness of the FDA 510(k) Clearance Process, IOM June 14,

9 The Regulatory Challenge Revitalize the medical innovation ecosystem Fewer submissions Reduced investment Ecosystem requirements: Innovative, value added ideas Financing Infrastructure Regulatory Payment Regulatory certainty and predictability v. flexibility Satisfying the critics of industry and FDA 2012 Faegre Baker Daniels LLP. All rights reserved 9

10 Days CDRH Average Time to 510(k) Decision Fiscal Year (Decision Cohort) *SE and NSE decisions only; times may not add to total due to rounding Total FDA Submitter 2012 Faegre Baker Daniels LLP. All rights reserved 10

ODE Attrition Year Overall Reviewer Manager Support Staff Other 2004 10.9% 11.9% 5.0% 10.3% 12.0% 2005 9.8% 10.0% 9.5% 11.1% 7.4% 2006 8.2% 9.6% 9.3% 3.0% 0.0% 2007 9.

13 ODE Attrition Year Overall Reviewer Manager Support Staff Other % 11.9% 5.0% 10.3% 12.0% % 10.0% 9.5% 11.1% 7.4% % 9.6% 9.3% 3.0% 0.0% % 10.4% 8.9% 5.9% 3.3% % 5.9% 6.4% 5.9% 3.7% % 9.0% 13.0% 9.1% 12.0% % 9.2% 6.8% 17.2% 3.0% 2012 Faegre Baker Daniels LLP. All rights reserved 13

15 Addressing the Challenges Resources Substantial increase in user fees Offset by risk of 8% budget cut FDA processes Innovation initiative Potential external management review Access to external experts Appeals Center Science Council Culture Hardest to address Long term employees ( lifers ) have preset views Counter pressure by medical KOLs Key ongoing issue Educational opportunities 2012 Faegre Baker Daniels LLP. All rights reserved 15

16 Key Regulatory Drivers Major reassessment of 510(k) system Driven by concerns over safety Loss of support from medical KOLs NEJM, JAMA, medical societies Press reports EU comparisons IOM report challenges 510(k) system EU/US debate Which is safer? Which is better for innovation? 2012 Faegre Baker Daniels LLP. All rights reserved 16

Current Regulatory Initiatives Affect the Entire Product Life Cycle Basic Research Transitional Research Venture Funding Pre Competitive : Research Resources Clinical Trials Protocol design and

17 Current Regulatory Initiatives Affect the Entire Product Life Cycle Basic Research Transitional Research Venture Funding Pre Competitive : Research Resources Clinical Trials Protocol design and clinical trial agreements Pre-Market Activity Submission, Review Approved Payment & Coverage Security and Brand Protection Market Facing Activities Post-Market Activities In fluency/shaping The Market Through Policy HYPOTHESIS TO HEALTH RESEARCH CLINICAL RESEARCH COMMERCIALIZATION POST MARKET Feasibility Pivotal studies New clinical trial guidance 510(k) program Post market orders FIH Modifications Recalls Risk/benefit definitions De novo QSR Center Science Council Appeals Reclassification Faegre Baker Daniels LLP. All rights reserved

18 Current Overarching Themes Effort to upclassify from 510(k) to PMA Increased effort to rescind 510(k)s and predicates More limited scope of 510(k) system Creation of internal oversight and review systems Data requirements equal or modestly more Desire for more oversight of modifications Some efforts to encourage IDE studies Innovation initiatives for a very small number of products Substantial attention on more post market requirements 18

19 Key Regulatory Developments New 510(k) program guidance Defines how 510(k)s are assessed Which pathway and what process More limited use of predicates Split predicates and reference devices Risk/benefit factors How your product will be assessed Critical for product design and clinical studies Role of patient choice and risk tolerance De novo Pathway for innovation? Reclassification 2012 Faegre Baker Daniels LLP. All rights reserved 19

20 The Predicate Conundrum Predicates key for 510(k) submissions Draft guidance reduces predicate options and how predicates can be used CDRH under attack for permitting multiple and split predicates Creation of primary predicate and reference device Draft guidance essentially prohibits split predicates split predicates are inconsistent with the 510(k) regulatory standard Impact on products combining prior uses or technologies Guidance limits use of multiple predicates Need to identify one primary predicate 20

21 Types of Predicates Guidance creates different types of predicates primary predicate Other or multiple predicates Reference devices Submission will need to clearly identify which is which These classes of predicates not found in statute or regulation Use of guidances for substantive changes? Are reference devices a predicate in disguise? Note limited use of reference devices Submissions will need to change if this becomes final 21

22 Effectiveness Factors (Benefit) Extent of benefit 4 subtypes Can be measured directly or indirectly Type of benefit (see 21 CFR 860.7(e)) Physical or clinical effects Clinical management Patient satisfaction Broad range life saving to relief of minor symptoms Magnitude of benefit Individual patient assessment Effort to use some scale of benefit Probability of benefit Overall probability Subgroup assessments Duration of benefit 22

23 Safety (Risk) Factors Extent of harm 4 sub factors Severity of harm Types of harm Serious Non-serious Indirect Number and rates Probability of harm Role of subgroup analysis Duration of harm Permanent Temporary Risk of false negatives and false positives Primarily diagnostic consideration 23

24 Other Key Regulatory Developments 510(k) modifications When to submit for a product improvement Impact on innovation Critical issue for industry Probable legislative fix Center Science Council Role being defined Post market authorities More general authority More submission specific authority (e.g. 522 orders) Risk communication processes Predicate rescission Risk to industry 2012 Faegre Baker Daniels LLP. All rights reserved 24

25 New Strategic Approaches Need for integrated regulatory strategy from the start Clinical trial design Consider new risk/benefit factors Determine patient risk tolerance Consider parallel review between CMS and FDA Formal and informal processes Consider de novo pathways for innovative products Don t be as afraid of PMA products Innovation initiative Take advantage of pre-ide meetings Document and remind 25

26 New Strategic Approaches Gather support from KOLs Medical, provider, payors Understand antikickback limitations Understand new 510(k) program processes Predicate identification Data needs Processes Can reclassification be your friend? Importance of QSR Use of post market to speed premarket approval Strategic product modifications Bundling of changes 26

27 Conclusions FDA will be in a state of flux for some time External factors Internal views of lifers Final regulations and guidance on hold until post election Upcoming election will impact FDA directly New Commissioner or new mandate to regulate Supreme Court decision has ripple effects on FDA User fee dates will be important to FDA Pro enforcement mindset Remember the states, Enforcement as revenue Importance of regulatory strategy 2012 Faegre Baker Daniels LLP. All rights reserved 27

28 Conclusions Some potential short term relaxation in agency data requests Effort to blunt criticism Reviewer and branch dependent Ongoing public and political challenges Challenge of Medical KOLs Ongoing guidance development Few final regulations pre election Substantial activity post election Substantial guidance development activity in could be a major inflection point 2012 Faegre Baker Daniels LLP. All rights reserved 28

29 Questions, Comments and Discussion 29

Overhauling The 510(k) Process

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