Combination Products CBER Report

1
Combination ProductsCBER Report

• MDUFAMA Educational Seminar
• November 2002

2
Designation of Regulation of Combination Products

• Achievements
• 1. Establish Office of Combination Products
  within 60 days
• 2. Prompt assignment of lead center
• 3. Timely and effective premarket review
• 4. Consistent and appropriate postmarket
  regulation
• 5. Timely and effective dispute resolution
• 6. Revision of guidance and agreements
• 7. Annual Report to Congress on activities

3
Combination Office Functions

• Establishes office within the Office of the
  Commissioner to ensure
• Prompt and Proper assignment to centers
• Consult with Ombudsmans Office on combinations
• Timely and effective premarket review
• Consistent/appropriate postmarket regulation
• Development of guidances/clarifications of
  regulations
• Serves as an advocate for combinations

4
Timing and Structure of Office

• To be established within 60 days (public meeting
  to be held Nov. 25)
• To be headed by a director, staffed with
  appropriate scientific and medical expertise

5
Offices Role in Assigning Jurisdiction

• Role in Premarket Review
• Prompt assignment of primary jurisdiction for
  premarket review
• Proper assignment (primary mode of action) of
  agency center.

6
Combination Offices Role in Ensuring Timeliness
of Premarket Reviews

• Will oversee timeliness of premarket review and
  coordinate reviews involving more than one center
• Center of primary jurisdiction and consulting
  center/s are responsible to this Office for the
  timeliness of reviews
• The Office will handle disputes involving
  timeliness, unless clearly premarket

7
Combination Offices Role in Ensuring Effective
Premarket Review

• Office will facilitate and coordinate reviews.
  Examples
• July SOP on consultative/collaborative process
• Awareness reviews
• October self-assessment report
• For disputes involving substance, first reviewed
  by center with primary jurisdiction, under its
  dispute resolution procedures. Then, the
  Commissioners Office will handle, consulting
  with the Office of Combination Products.

8
Offices Role with Respect to Postmarket
Requirements

• Office will ensure consistency and
  appropriateness of postmarket regulations
• Consistent like products to be treated in like
  fashion
• Appropriate changes as necessary in accordance
  with applicable law.
• Questions left unanswered (Nov. 35 hearing)
• Reconciliation of like products
• Consistency vs. Appropriateness
• Definition of like products

9
Offices Role with Respect to Agreements,
Guidances, Practices

• Will review any agreement, guidance or practice
  specific to assignment of combinations to ensure
  consistency with 503(g)(4)
• Will consult in this review with stakeholders and
  directors of centers.
• May continue, modify or eliminate any agreement,
  guidance, or practice, and publish notice in
  Federal Register
• Question What is the true extent of this
  authority?

10
Offices Report to Congress

• One year after date of enactment, and annually
  thereafter
• Shall include
• Numbers and types of combo products reviewed and
  timeliness of assignments, reviews, and dispute
  resolutions
• Number of reviews involving consulting center
• Improvements in consistency of postmarket
  regulation of combo products

11
Designation of Regulation of Combination Products

• Achievements
• 1. Establish Office of Combination Products
  within 60 days
• 2. Prompt assignment of lead center
• 3. Timely and effective premarket review
• 4. Consistent and appropriate postmarket
  regulation
• 5. Timely and effective dispute resolution
• 6. Revision of guidance and agreements
• 7. Annual Report to Congress on activities

12
Report on Certain Devices (a.k.a. CBER Report)

• Report to Congress required within one year of
  enactment
• Report will cover timeliness and effectiveness of
  device premarket reviews by centers other than
  CDRH

13
CBER Report

• Report contents
• Times required to log in and review original
  submissions and supplements
• Times required to review manufacturers replies
  to submissions
• Times to approve or clear such devices
• Recommendations on any measures needed to improve
  performance, including allocation of additional
  resources

14
CBER Report

• Report will include recommendation on whether
  responsibility for regulating devices reviewed by
  other centers should be reassigned topersons
  charged with regulating other types of devices
  and whether transfer could have adverse impact on
  device safety and public health.

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Implications of Report

• Authorship (preserving neutrality and
  independence)
• Open products should not be transferred until
  report issued
• Annual reports may be needed, depending on
  finding outcomes
• Procedural vs. Substantial Expertise Solutions
  to the public health issue