1. Gathering Clouds and Legislative Change by Mark A. Heller MassMedic 13 th Annual Conference May 5, 2009

2. 2 ALLEGATIONS Media Criticism (510(k) Process)  N.Y. Times (January 16, 2009) –  “Most medical devices have never been shown to be safe or effective, and for the riskiest devices this must change, Congressional investigators concluded in a report released Thursday.”  “Most medical devices are given quick approvals with minimal testing because manufacturers tell the FDA that the products operate just like older devices that had already been approved.”  WSJ (March 6, 2009) –  “[The device] was approved under fast-track rules that don’t require clinical trials needed under a full review.”  “Dr. von Eschenbach,..., is calling for an overhaul of the way the $200 billion-a-year medical device business is regulated. The fast-track system ‘has gotten out of control,’ he said.” (Cont’d)

3. 3 The Media and Preemption  N.Y. Times (March 15, 2009 - Editorial)  “Now that the Supreme Court has ruled that patients can sue drug companies in state courts for harm caused by medicines approved by the Food and Drug Administration, Congress ought to give patients the same right to sue makers of medical devices.”  “Suits in state courts reinforce federal regulations. Patients who have been hurt by faulty medical devices should have the right to seek redress there.”

4. 4 Employee Letters  May 31, 2008 – Commissioner von Eschenbach  October 14, 2008 – Congressman Dingell  January 7, 2009 – John T. Podesta, Transition Team  April 2, 2009 – President Obama & Senator Grassley  Allegations oManagerial Misconduct o“Corruption” of the premarket review process oManagement’s lack of scientific/clinical expertise oHostile work environment/retaliation oConduct endangering the Public Health (Cont’d)

5. 5  Letters’ Flavor o“Rather than recall, re-evaluate or otherwise deal with potentially unsafe or ineffective devices that are already on the market, these managers at CDRH continue to approve more devices of the same kind in a non-transparent and non-scientific manner. This is especially true of the 510(k) program but also applies to the PMA Program as well as the advice and guidance given to manufacturers before they make regulatory submissions.” Oct. 14 Letter at 3. o“Since May 2008, the FDA Commissioner has been provided with irrefutable evidence that managers at CDRH have placed the nation at risk by corrupting and distorting the scientific evaluation of medical devices, and by interfering with our responsibility to ensure the safety and effectiveness of medical devices before they are used on the American public.” Jan. 7 Letter at 1.

6. 6 Legislative Change ?

7. 7 Premarket Notification/510(k): What is it? Medical Device Amendments of 1976  Premarket Regulation  Class I Devices – General Controls  Class II Devices – Performance Standards  Class III Devices - PMA  Preamendments Devices  Classification by Rulemaking  Class II Standards by Rulemaking  Class III PMAs by Rulemaking  Classification of Post-Amendments devices  Automatic classification/PMA  SE  NSE  NOT AN APPROVAL  Implementation Led to Regulatory Gap  No standards  Few PMA regulations  510(k) became the only premarket review for class IIs and preamendments class IIIs (CONT’D)

8. 8 “Medical Device Regulation: The FDA’s Neglected Child” Report by Subcommittee on Oversight and Investigations, Committee on Energy and Commerce, May 1983  “Although generally not discussed as a general control, the requirement in section 510(k) for a manufacturer to notify FDA at least 90 days before first introducing a device into the market has proven to be one of the most important provisions in the device amendments.... Congress may well have anticipated a large volume of these premarket notifications,..., but it did not envision the importance these submissions would play in resolving a high volume of significant regulatory decisions by the agency.” Report at 8 (Emphasis added).  “The three-tiered regulatory system created by Congress has been collapsed by FDA inaction into a system that treats the most hazardous device virtually as if it were the least hazardous —that virtually treats coronary bypass blood oxygenators as if they were no more hazardous than tongue depressors.... [Congress] clearly did not intend all devices to be subject to the same set of regulatory controls—the minimum controls at that.” Report at 34 (Emphasis added). (CONT’D)

9. 9  “Given that the 510(k) process—by default—has become a more important regulatory tool than Congress envisioned, two conclusions are apparent. First, until the agency has taken serious steps to implement the statutorily mandated three-tiered regulatory system created to assure that marketed devices are safe and effective, any attempt to weaken the 510(k) process— especially to facilitate the entry of class II and class III substantially equivalent devices into the market— should be resisted. This conclusion is by no means an endorsement of the use of the 510(k) process as a substitute for class II and III regulatory controls. It simply recognizes that no matter how desirable or necessary, these controls cannot be fully implemented to provide protection immediately. Something must continue to fill the gap while the agency begins to put the mandated controls in place.” Report at 35 (Emphasis added).

10. 10 Safe Medical Devices Act of 1990  Codified FDA’s 510(k) program  “The Committee believes that it is important to codify the [FDA’s] interpretation of the terms ‘substantial equivalence’ and ‘substantially equivalent.’” Senate Report at 28.  “The bill modifies the statutory authority for the FDA to consider the safety and effectiveness of a device when determining whether such a device is substantially equivalent to a predicate device.” House Report at 24 (Emphasis added).  "The Committee recognizes that the FDA does not always need clinical data to make a finding of substantial equivalence.... The Committee believes that it is appropriate for the FDA to request such information when necessary. It is not the intent of the Committee to make such data a necessary element of every substantial equivalence determination.” House Report at 25 (Emphasis added). (CONT’D)

11. 11  Required Transparency for SE decisions  Summaries of Substantial Equivalence, or  Statements  For Preamendment Class III Devices not subject to PMAs — Require certification of a “reasonable search of all information known or otherwise available to the manufacturer” regarding the 510(k) device and its predicates  Increased postmarket controls for FDA: PMS, reports of removals and corrections, device tracking, mandatory recalls, and civil penalty authority  Class II and Preamendment Class III Devices  Class II oAbandoned Standards oCreated Special Controls  Class III oRequest Information oBy regulation, reclassify or maintain in Class III by 12/1/95 oNo later than 12 months after regulations retaining devices in class III, set timetable to request PMA data (CONT’D)

12. 12  “Less Than the Sum of Its Parts” Report by Subcommittee on Oversight and Investigations Committee of Energy and Commerce, May 1993  “The basis for the SMDA was the recognition that: --over 80 percent of the riskiest devices (class III) was being allowed market entry under FDA’s 510(k) process. This process did not require FDA to determine that any of these devices were safe and effective....” Report at 13 (Emphasis added).  “The question that needs to be answered is whether a more streamlined approach can be crafted consistent with present statutory mandates.” Report at 64 (Emphasis added).

13. 13 Food and Drug Administration Modernization Act of 1997  Class I and II Exemptions  Third Party Review  “Least Burdensome”  Recognition of Standards  Risk Based/De Novo Classification Medical Device User Fee and Modernization Act of 2002  510(k)s  PMAs Food and Drug Administration Amendments Act of 2007  Extension of user fees

14. 14 510(k) Conclusions 510(k) as a classification tool is effective, efficient and necessary Ultimately the real concern with the 510(k) process is its use as a surrogate for PMAs and performance standards/now special controls, i.e., an implementation not a legal authority or program structure concern Currently, FDA is addressing the preamendments PMA issue to ensure either the reclassification or the submission of PMAs for preamendments Class IIIs Reclassified preamendments Class III devices will have special controls to qualify for Class II regulation For higher risk Class IIs, FDA could selectively reopen classification regulations and include special controls for each such type of device that requires them to provide reasonable assurance of safety and effectiveness In sum, effective implementation of FDA’s authority can address the alleged major deficiencies of the 510(k) process; amendments to the FDCA will not achieve much or advance the public health

15. 15 Preemption SEC. 521. [21 USC 360k ] State and local requirements respecting devices (a) General Rule. Except as provided in subsection (b), no State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement— (1) which is different from, or in addition to, any requirement applicable under this Act to the device, and (2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this Act. (Cont’d)

16. 16 Supreme Court Cases Medtronic v. Lohr, 518 U.S. 470 (1996) –design, manufacturing and labeling claims  510(k) does not preempt tort claims because a substantial equivalence determination does not amount to a specific, federally enforceable requirement applicable to a particular device.  Rejects position that section 521 preempts all common law cases, and deferred on whether section 521 never preempts common law claims (Cont’d)

17. 17 Riegel v. Medtronic, 522 U.S. __; 128 S. Ct. 999 (2008)  Common law claims of negligence and strict liability impose requirements within the ordinary meaning of that term  PMA approvals preempt state common law claims challenging safety and effectiveness if the device is in the form that was approved by FDA, and the claim is not based upon a theory the defendant violated federal law  Thorough safety and effectiveness review  Each approval creates a set of requirements  Need approval for changes  Authority to withdraw approval

18. 18 Wyeth v. Levine, 555 U.S. __ (March 4, 2009)  Failure to warn claim related to NDA approved drug  Although warnings on the specific cause of the plaintiff’s injury, Court held stronger warnings could have been included that would have satisfied federal and state requirements  Wyeth’s claim that it would be impossible to accommodate state and federal law was rejected by the Court because Wyeth could have altered its label under the Changes Being Effected regulation without first receiving FDA’s approval  Congress chose not to authorize preemption for drugs  Where Congress has not authorized preemption, the Court will assess the weight accorded an agency’s explanation of a state law’s impact on the federal regulatory scheme  “Although we recognize that some state-law claims might frustrate the achievement of congressional objective, this is not such a case.”

19. 19 Draft Device Preemption Legislation Introduced Bills (March 5, 2009)  H.R. 1346 – Sponsor: Rep. Frank Pallone, Jr.; 78 Co- sponsors  S. 540 – Sponsor: Sen. Edward Kennedy; 20 Co- sponsors Each Bill entitled “Medical Device Safety Act of 2009” Identical Bills  Added language to the end of section 521 to negate device preemption as it applies to tort suits  Effective date: May 28, 1976 to “apply to any civil action pending or filed on or after the date of enactment of this Act.”

20. 20 Now a Matter of Policy and Not Law Distinction between the device and drug industries? Effect on small companies and innovation? Effect on patient costs in response to increased litigation costs? Public health implications of losing preemption?