Trends in Postmarket Surveillance

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Trends in Postmarket Surveillance

• MassMEDIC FDA Update
• December 9, 2005

Paul T. Kim Food and Drug Counsel
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• Background
• Congressional Oversight
• Pending Issues

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Postmarket surveillance studies

• Safe Medical Device Amendments
• Section 522 of the FFDCA applied to -
• permanent implants, the failure of which may
  cause serious adverse health consequences or
  death
• devices intended for use in supporting or
  sustaining human life or
• devices that present a potential serious risk to
  human health
• Additional discretionary authority for other
  devices if deemed necessary to protect the public
  health

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Adverse Reporting Systems
Product Problems
Voluntary Reporting
Mandatory Reporting
FDA
Clinical Problems

• Voluntary reporting (3) Mandatory reporting
  (97)
• 125,000 reports annually 1.25 million total

Source CDRH Director Schultz
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Change in authority

• SMDA
• permanent implants, the failure of which may
  cause serious adverse health consequences or
  death
• devices intended for use in supporting or
  sustaining human life or
• devices that present a potential serious risk to
  human health

• FDAMA
• failure would be reasonably likely to have
  serious adverse health consequences
• devices intended to be implanted in the human
  body for more than one year or
• devices intended to be a life sustaining or life
  supporting device used outside a device user
  facility

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MDUFMA Funding

• Authorized 3 million for FY 2003, 6
  million for FY 2004 and such sums as may be
  necessary thereafter for postmarket surveillance
• Congress did not appropriate any of these funds

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IOM Study

• FDA lacks effective procedures to monitor
  postmarket surveillance studies
• Congress should make sure FDA establishes a
  reliable system to track these postmarket
  studies
• Congress should give the agency the authority to
  require studies for certain devices as a
  condition of clearance
• Congress should remove the three-year time limit
  on studies where devices are intended for use in
  children

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Follow Up FDA Report

• Sec. 212(c) report by October 26, 2006
• Based on and describing the IOM findings on
  pediatric postmarket surveillance
• Include any recommendations of the Secretary for
  administrative or legislative changes to the
  system of postmarket surveillance

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MDUFMA Study

• Section 104(b) report by January 10, 2007 on --
• the effect of user fees on FDAs ability to
  conduct postmarket surveillance
• the extent device companies comply with
  postmarket surveillance requirements
• any improvements needed for adequate postmarket
  surveillance, and the amount of funds needed to
  do so
• recommendations as to whether, and in what
  amount, user fees should be used for postmarket
  surveillance

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• Background
• Congressional Oversight
• Pending Issues

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Grassley Public Disclosure

• ICD manufacturers must report to the FDA the
  number of patient deaths, analyses of failure
  mechanisms, and other safety and effectiveness
  issues State why the FDA should not
  proactively post such information.
• Why is important device performance
  information reported to the FDA by device
  manufacturers, but not publicly available to
  patients, health care providers and the
  scientific community.
• Letters to Commissioner Crawford on Guidant
  Ventak Prizm 2 DR (July 18 and 20, 2005)

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Grassley CDRH Performance

• FDA is neither properly monitoring postmarket
  studies nor making important postmarket research
  publicly available.
• Dr. Crawford, these are the same kinds of
  problems weve seen with the postmarket review of
  medicines...
• Letter to Commissioner Crawford on Oukrop death
  and Guidant Ventak Prizm 2 DR (July 20, 2005)

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Grassley Guidant Compliance

• National health care programs shouldnt have to
  rely on a three strikes and youre out program
  when lives are at stake.
• The Institute of Medicine spells out remedies
  that should be pursued to better protect children
  who rely on FDA-approved medical devices, and I
  intend to work to help improve the situation.
• Statement upon issuing document request to
  Guidant (September 22, 2005)

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Prospects Senate Oversight

• Agency under pressure Crawford and protest
  resignations, Plan B, COX-2 and SSRI
  controversies, ICD recalls
• Freestanding legislation hampered by lack of
  committee jurisdiction
• Grassley oversight continues unabated
• Members and staff view as oversight function, not
  grandstanding
• Adverse product developments foster scrutiny
• Where are the committees of jurisdiction? Does
  inaction mean no issues deserve scrutiny?

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Prospects Legislation

• Grassley and Dodd already collaborating on drug
  safety legislation
• Dodd has record on pediatric FDA issues
• Election year offers ample lead time into MDUFMA
  reauthorization process
• MDUFMA is must pass legislation
• Will legislation follow convergence of Medicare
  CED and FDA postapproval requirements?

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• Background
• Congressional Oversight
• Pending Issues

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Issues Compliance and Implementation

• Did IOM highlight inadequate agency tracking of
  study initiation, progress and completion?
• Or have manufacturers failed to comply with study
  obligations or to report study results?
• Have COA and postmarket studies been required for
  the right products and in the right manner and
  mix?
• Is postmarket data reviewed by CDRH in an
  appropriate and timely manner?

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Issues Statutory Authority

• Should the 1997 amendment of postmarket
  surveillance authority be revised?
• Are new or tougher sanctions warranted?
• Is the statutory limit of 36 months warranted?
• Do MDR regulations require amendment?
• Should MedSun be expanded or additional
  surveillance systems be created?

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Issues Conflicts of Interest

• Does reliance on user fees promote agency
  capture? Bias review decisions?
• Does CDRHs increasing use of outside experts and
  fellows, and stringent timelines affect its
  objectivity?
• Should COI waivers be eliminated for CDRH
  advisory committees?

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MDUFMA Conduct of Reviews

• Is CDRH issuing non-approvable decisions to beat
  the clock?
• Do the performance goals reflect meaningful
  improvements in time to market?
• Are fee revenue being expended by CDRH in
  appropriate ways?
• How can agency performance on modular PMAs be
  improved?

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MDUFMA Funding

• Are current fees adequate to meet CDRH resource
  and staff needs commensurate to the performance
  goals?
• Are current fees too high? Did they increase too
  quickly since 2002?
• Can Congress be trusted to provide CDRH adequate
  discretionary funding?
• How can a company with 100 million annual
  revenue qualify as a small business?
• Good government doesnt come cheap

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MDUFMA Other Policies

• What is the value of third party review when
  review times are comparable to CDRH?
• Why havent more sponsors used the third party
  inspection program?
• Is SUD reprocessing a public health issue, or
  merely one of competition?

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Thank you
Paul T. Kim 202.261.7360 pkim_at_foleyhoag.com