Top 10. Changing Enforcement Environment. The Fourth Annual Medical Device Regulatory, Reimbursement and Compliance Congress November 10, 2009

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1 The Fourth Annual Medical Device Regulatory, Reimbursement and Compliance Congress November 10, 2009 Roundtable on the Top 10 Device Manufacturer-FDA Regulatory Issues Dorothy J. Clarke, Esq., Vice President, Regulatory Affairs, Office of Compliance, Medical Devices and Diagnostics, Comprehensive Care and Surgical Care, Johnson & Johnson Gregory H. Levine, Esq., Partner, Ropes & Gray LLP Danelle R. Miller, Esq., Director and Regulatory Counsel, Roche Diagnostics Corporation Lauren R. Silvis, Esq., Associate, Sidley Austin LLP 2 Top Changing enforcement environment 2. Corrective Fix Pilot (k) data requirements 4. Postapproval requirements 5. Device registries and role of the initiative 6. Unique Device Identifiers 7. Draft guidance on risk communication 8. Regulation of diagnostics: CLIA vs. OIVD 9. Companion diagnostics 10. Software regulation Changing Enforcement Environment 3 Backlash against perception of lax enforcement 483 policy: responses must be received within 15 working days to be considered prior to issuance of a Warning Letter No repeat WLs Eliminating OCC review of all WLs Will focus on speed result in ill-considered regulatory actions? What are the consequences? Return to the bad old days of inconsistency and questionable legal grounds for allegations?

2 Changing Enforcement Environment 4 What else to expect? Increase in formal enforcement actions (seizures, consent decrees) Greater use of seldom (or never) used authorities (e.g., civil money penalties, clinical investigator financial disclosure, mandatory recalls, mandatory notification, repair/replacement/refund, administrative detention)? What should device companies be doing now to reduce risk? Ensure adequately resourced compliance functions Where necessary, ramp up auditing rigor If culture needs changing, don t wait 5 Corrective Fixes Pilot A rumored program that presumes applications to change legally marketed devices are safety-related Could result in recall of the old product If true, raises transparency questions Prompted by cases like In re Medtronic Sprint Fidelis Leads Products Liability Litigation? Plaintiffs argued that after FDA approved a new version of the device, Medtronic should have stopped selling the original, defective version Court correctly rejected this claim because FDA had not found the old device unsafe or revoked its approval 6 Corrective Fixes Pilot Plaintiffs have cited no federal regulation or other requirement suggesting that a previously issued PMA is withdrawn or somehow loses its vitality when a device improvement is granted PMA. Nor does such an assertion make intuitive sense. In many situations, devices may be improved not because they are unsafe, but simply because a newer version is better in some fashion-just as the Sprint Quattro leads purportedly were better than Medtronic's Transvene Leads. 592 F.Supp.2d 1147 (D.Minn. 2009)

3 510(k) Program 7 Institute of Medicine to report to FDA Does 510(k) process optimally protect patients and promote innovation in support of public health? If not, recommend legislative, regulatory, or administrative changes ReGen Menaflex review and report Internal agency procedures Additional review of new indications Clinical data requested for devices previously cleared without such data Data requirements becoming more like PMA Clinical data from prospective trials Human factors studies Validation studies Focus on actual use Postapproval Requirements Officially, CDRH focused on post-market risk management since January 2006, but with an emphasis on risk communication and enforcement actions Ensuring the Safety of Marketed Medical Devices: CDRH s Medical Device Postmarket Safety Program (2006) Postmarket Transformation Leadership Team: Strengthening FDA s Postmarket Program for Medical Devices (2006) Launch of a new public web page highlighting device safety issues and focusing on problem devices (2007) Now increasing use of postmarket studies and focus on monitoring progress and results Section 522 postmarket surveillance for pedicle screw systems Collect clinical data on potential safety issues Clinical data needed for new systems or components Also considering REMS-like powers? 8 9 Device Registries and the Role of FDAAA mandated that FDA establish an active surveillance system for monitoring drugs, using electronic data from healthcare information holders FDA launched in response in May 2008 and included devices Network of healthcare databases that can be actively queried to identify safety issues Data continues to be managed by owners; FDA sends inquiries Privacy and security safeguards

4 10 Device Registries and the Role of FDA is encouraging creation of registries for inclusion in the network Efforts towards an orthopedic implant surveillance registry linking disparate registries Contract with U. of Cincinnati pediatric medical center to compile a compendium of pediatric registries, with goal of inclusion in For some product-specific postmarket surveillance or COAs, FDA encouraging manufacturers to use existing registries E.g., Thoratec LVAD using NHLBI s INTERMACS 11 Device Registries and the Role of Congressional interest in registries House health reform bill would mandate a "National Medical Device Registry" for all class III devices and all class II devices that are implantable, life-supporting or life-sustaining Other pending legislation would mandate a national orthopedic implant surveillance registry for hip and knee replacement devices within the Agency for Healthcare Research and Quality 12 Unique Device Identifiers FDAAA requirement for FDA to issue regulations establishing a UDI system Requires device labels to bear a UDI unless FDA provides an exception The UDI shall adequately identify the device through distribution and use Proposed rule predicted to come out in 2010 Key issues Scope of requirement Physical placement on packaging or device UDI database Global implications

5 Draft Guidance on Risk Communication Draft Guidance: Presenting Risk Information in Prescription Drug and Medical Device Promotion (May 2009) Considers the net impression the message communicated by the piece as a whole Consistent use of language appropriate for target audience (professional or patient) Considerations of quantity, materiality, and comprehensiveness of risk information Recommendations for format, including location of risk information in print promotion Draft Guidance on Risk Communication One size fits all approach applies drug concepts to devices Less clarity on expectations for device promotion No device-specific advertising regulations CDRH OC does not make public untitled letters on promotional issues Most devices do not have benefit of relying on for guidance labeling analogous to FDA-approved PI, which goes through extensive sponsoragency negotiations, and advisory comments on promotional pieces Need to distinguish between requirements specific to promotional labeling and advertising Emphasis on comparability of information rather than unique benefit/risk profile of each device Regulation of Diagnostics 15 FDA exercises discretion not to regulate most labdeveloped diagnostic tests (LDTs) Genentech citizen petition CLIA regulation is insufficient to ensure reliability Future of personalized medicine depends on reliable LDTs FDA should regulate all LDTs using a risk-based approach American Clinical Laboratory Association response Absence of evidence of harm associated with incorrect LDT results CLIA regulations are rigorous on analytical validation If clinical validation requirements are inadequate, solution is to revise CLIA rules or guidance FDA lacks authority to regulate LDTs: labs sell services, not devices FDA initiatives on ASRs, IVDMIAs

6 Companion Diagnostics 16 Ideal is co-developed drug and diagnostic, e.g., Herceptin and HER2 test But this is the rare example in most cases, diagnostic test approved or cleared after association identified, e.g., EGFRs and K-RAS Inconsistent views on importance of validated diagnostic before labeling is changed? CDER/CBER and OIVD Affected by policy issues relating to LDTs and regulation of genetic testing Driven by science When biomarkers identified, impulse to use in treatment decisions as soon as possible Regulation and approvals may lag behind Critical Path issue Software Regulation 17 Medical Device Data System (MDDS) proposed rule MDDS = a device that electronically stores, transfers, displays, or reformats patient medical data without diagnostic or clinical functions Preamble asserts that these are Class III devices What happened to the accessory device policy? What are the implications for other products? What s FDA s enforcement discretion policy? Can one register/list a gray zone product?

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