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Gathering Clouds and Legislative Change by Mark A. Heller

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Safe Medical Devices Act of 1990. Codified FDA's 510(k) program ' ... This process did not require FDA to determine that any of these devices were safe and effective. ... – PowerPoint PPT presentation

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Title: Gathering Clouds and Legislative Change by Mark A. Heller


1
Gathering Clouds and Legislative ChangebyMark
A. Heller
  • MassMedic 13th Annual
    Conference
  • May 5, 2009

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 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)

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
  • 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)

5
  • 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.

6
Legislative Change
  • ?

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

8
  • 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)

9
  • 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).

10
  • 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)

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
  • 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)

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 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).

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
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

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.
  •   (Contd)

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 (C
    ontd)

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
  • 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.

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
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?
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