Gathering Clouds and Legislative Change by Mark A. Heller

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Gathering Clouds and Legislative ChangebyMark
A. Heller

• MassMedic 13th Annual
  Conference
• May 5, 2009

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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 dont 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.
• (Contd)

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• 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.

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• 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
• Managerial Misconduct
• Corruption of the premarket review process
• Managements lack of scientific/clinical
  expertise
• Hostile work environment/retaliation
• Conduct endangering the Public Health
• (Contd)

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• Letters Flavor
• 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.
• 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.

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Legislative Change

• ?

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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

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• Medical Device Regulation The FDAs 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 controlsthe minimum
  controls at that. Report at 34 (Emphasis
  added).
• (CONTD)

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• Given that the 510(k) processby defaulthas
  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)
  processespecially to facilitate the entry of
  class II and class III substantially equivalent
  devices into the marketshould 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).

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• Safe Medical Devices Act of 1990
• Codified FDAs 510(k) program
• The Committee believes that it is important to
  codify the FDAs 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).
• (CONTD)
  

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• 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
• Abandoned Standards
• Created Special Controls
• Class III
• Request Information
• By regulation, reclassify or maintain in Class
  III by 12/1/95
• No later than 12 months after regulations
  retaining devices in class III, set timetable to
  request PMA data
• (CONTD)

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• 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 FDAs
  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).

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• 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

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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 FDAs
  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

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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.
•   (Contd)

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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 (C
  ontd)

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• 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

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• 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
  plaintiffs injury, Court held stronger warnings
  could have been included that would have
  satisfied federal and state requirements
• Wyeths 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 FDAs approval
• Congress chose not to authorize preemption for
  drugs
• Where Congress has not authorized preemption, the
  Court will assess the weight accorded an agencys
  explanation of a state laws 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.

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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.

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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?