PROGRAM DESCRIPTION: Office of Medical Policy

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MANUAL OF POLICIES AND PROCEDURES

CENTER FOR DRUG EVALUATION AND RESEARCH                                                                    MAPP 4301.1


                                     PROGRAM DESCRIPTION

                                 OFFICE OF MEDICAL POLICY

           Center for Drug Evaluation and Research Medical Policy Council


                                             Table of Contents

                 PURPOSE ..............................................................................1
                 BACKGROUND ...................................................................1
                 ORGANIZATION ................................................................2
                 RESPONSIBILITIES ...........................................................3
                 PROCEDURES .....................................................................5
                 AUTHORITY ........................................................................7
                 EFFECTIVE DATE ..............................................................7
                  ATTACHMENT 1 - Examples ............................................8
                  ATTACHMENT 2 - Template.............................................9
                  ATTACHMENT 3 - Flowchart

PURPOSE

This document describes the organization, membership, responsibilities, and procedures
of the Medical Policy Council in the Center for Drug Evaluation and Research (CDER).

The CDER Medical Policy Council will provide senior support to the Center on medical
policy development, including:
       Leadership oversight and medical policy management for the Center.
       Attention to, and management of, essential Center cross-cutting medical policy.
       Advocacy for the activities of this Council and its Working Groups.
       Promotion and coordination of communication both internally and externally on
the medical policy decisions made by the Council.

BACKGROUND

The CDER Medical Policy Council provides a senior level forum to establish medical
policy in CDER and its application to the new and generic drug review process, as well
as other CDER programs. The Council will help to ensure that medical policy is
implemented in a consistent manner throughout the Center.

The Council will meet on a regular basis to consider medical policy issues that are
precedent setting and require senior management input to resolve.



Originating Office: Office of Medical Policy
Effective Date: 03/19/13                                                                                    Page 1 of 10
MANUAL OF POLICIES AND PROCEDURES

CENTER FOR DRUG EVALUATION AND RESEARCH                                         MAPP 4301.1

Although the issue discussed by the Council may have been triggered by a specific
product, the policy established by the Council will be applied to all similar products.
Product-specific decisions will be remanded to the appropriate review division and/or
office for follow-up and implementation.

For the purposes of this Council, medical policy generally concerns one or more of the
following: (1) Clinical evidence of effectiveness or safety, (2) clinical study/trial design,
(3) professional and patient labeling, (4) prescription drug promotion, (5) human subjects
protection, (6) bioresearch monitoring, (7) good clinical practice, (8) counter-terrorism
drug development (such as in the application of the Animal Rule; 21 CFR 314.600), and
(9) postmarketing surveillance. To be considered by the Council, a medical policy issue
typically would meet one or more of the following criteria:
     A novel medical policy issue requiring senior management input;
     An issue on which CDER seems to have taken inconsistent positions;
     An existing medical policy position that should be reconsidered in light of
        scientific or regulatory advances;
     A complex safety management issue requiring senior management input ;
     A medical policy that may be triggered by a specific product, but that will be
        applicable to other products; or
     Strategies for implementation of a new policy.


ORGANIZATION

Membership
The CDER Medical Policy Council includes the following.
    Chair: Associate Director for Medical Policy
    Members:
      o Center Director
      o Deputy Center Director for Clinical Science
      o Director, Office of New Drugs
      o Director, Office of Surveillance and Epidemiology
      o A division director from a review division of the Office of New Drugs to
        participate on the council for a one year term
      o A medical officer from a review division of the Office of New Drugs to
        participate on the Council for a one year term

Executive Committee members will be advised on Council meeting agendas and will be
invited by the Council to attend and/or send a representative with expertise within their
offices on the medical policy issue to be discussed.

Nominations for division director and medical officer will be provided by the Director,
Office of New Drugs to the Council Chair for consideration.


Originating Office: Office of Medical Policy
Effective Date: 03/19/13                                                          Page 2 of 10
MANUAL OF POLICIES AND PROCEDURES

CENTER FOR DRUG EVALUATION AND RESEARCH                                     MAPP 4301.1

The Center for Biologics Evaluation and Research (CBER), the Center for Devices and
Radiological Health (CDRH), and any other relevant office within the Agency will be
invited by the Council to send a representative to attend those meetings of known
interest.

Working Groups
Working groups may be established by the Medical Policy Council if, among other
things, there is:
     an identification by the Council that there is a need based on factors such as its
        knowledge of CDER operations and policies or new concepts and innovation; and
     direction by the Center Director to the Council to establish a new expert working
        group to achieve specific objectives (e.g., developing guidance).

Working groups will have a limited lifetime. The working groups will adjourn when they
have successfully completed their goal or additional work is not required as determined
by the Council.


RESPONSIBILITIES

Responsibilities of the Council.
    Direct the development of policy, regulations, and guidances intended to
      communicate and implement consistent, standard policies and procedures related
      to medical policy for internal and external use.
    Establish and oversee working groups to accomplish specific assessments and
      projects.
    Review work products (e.g., documents and recommendations) of working groups
      before they are circulated for clearance.
    Promote and coordinate internal and/or external communication of medical policy
      decisions when appropriate.
    Develop agency-wide communications on medical policy decisions when
      appropriate.

Responsibilities of the Council members related to their organizational units.
    Represent their organizational unit's views on issues under consideration by the
      Council.
    Identify relevant stakeholders and their concerns to the medical policy issue under
      discussion.
    Nominate representatives from their organization's unit to participate in working
      groups to implement activities deemed necessary by the Council to meet goals
      and objectives.
    Identify agenda items.
    Attend meetings regularly.


Originating Office: Office of Medical Policy
Effective Date: 03/19/13                                                      Page 3 of 10
MANUAL OF POLICIES AND PROCEDURES

CENTER FOR DRUG EVALUATION AND RESEARCH                                     MAPP 4301.1

Responsibilities of the Council Chair.
    Provides leadership and direction to the Council.
    Reviews proposals and determines selection and prioritization of issues for
      consideration in conjunction when appropriate with Council members.
    Provides mediation and decision authority on issues that cannot reach consensus
      within the Council.
    Reviews nominations for the division director and primary medical officer
      positions on the Council.

Responsibilities of the Executive Secretary.
    Confirms meeting agendas and conduct meetings.
    Apprises the Chair of progress and activities.
    Promotes involvement and balanced participation of all members.
    Holds working group members accountable for completion of tasks.
    Reviews the briefs submitted and work with the individual or office to ensure that
      the brief is complete.
    Establishes working groups to address specific medical policy issues and
      challenges.
    Oversees working groups, holding them accountable for developing and executing
      plans.

Responsibilities of the Project Manager.
    Promotes relevant topics and content for agenda topics.
    Schedules meetings and communicate agenda prior to each meeting.
    Follows up on assignments and action items assigned to members.
    Prepares documents and papers as directed by the Executive Secretary.
    Serves as a focal point for the working groups.
    Maintains the rosters of the working groups.
    Maintains a repository that includes meeting notes, a log and status of issues
      discussed and actions assigned, and copies of Council decisions and actions.

Responsibilities of the working groups and their members.
    Develop project plans that include timelines and update the Council at regular
      intervals as designed by the Council.
    Confirm its objectives with the Council.
    Define workgroup member responsibilities.
    Provide work products to the Council in a timely manner.
    Respond to questions from the Council on specific issues.
    Advise and assist the Council in responding to agency staff and other queries.

Responsibilities of the individual and/or office seeking Council evaluation.
    Submits a proposal to the Executive Secretary for consideration by the Chair.


Originating Office: Office of Medical Policy
Effective Date: 03/19/13                                                      Page 4 of 10
MANUAL OF POLICIES AND PROCEDURES

CENTER FOR DRUG EVALUATION AND RESEARCH                                        MAPP 4301.1

       Provides a 3-5 page brief to the Project Manager, if proposal accepted, 2 weeks
        before the Council meeting. The brief (see attachment 2) should provide all the
        necessary information to understand the medical policy issue to be discussed.
        The brief should also include questions for the panel members to consider and
        provide resolution.
       Identifies a lead from the office seeking Council evaluation.
       Submits a list of attendees representing viewpoints on the medical policy issue to
        be discussed, if proposal accepted, to the Project Manager.


PROCEDURES

    1. Identification of issues.
             Medical policy issues may be submitted by any Center staff member.
               Although the medical policy issue may be triggered by product-specific
               discussion and review, the medical policy issue presented to the Council
               will not be product-specific.
             Medical policy issues may be developed from issues raised by the medical
               product industry, academia, political bodies, or other interested parties and
               brought to the attention of Center staff. The Council will consider
               whether opening a docket would be useful for soliciting outside
               stakeholder input on medical policy issues for discussion.
    2. The Chair will review proposed medical policy issues and select and prioritize
       issues for consideration with appropriate input from Council members. Such
       proposals should be no more than one-two paragraphs and include the following:
                The medical policy issue to be resolved.
                The trigger that raised the medical policy issue.
                The timeframe of when a response is needed.
    3. If the proposal is not selected to be reviewed by the Chair or cannot be reviewed
       by the Council by the timeframe specified, the Executive Secretary will provide
       an explanation of the Council's decision. Reconsideration by the Council of such
       decisions can be requested.
    4. If the proposal is selected, a pre-meeting may be scheduled between the Chair
       and/or Executive Secretary and the individual or office seeking Council
       evaluation to assist in refining the medical policy issue to be discussed.
    5. The medical policy issue will be summarized in a Medical Policy Council brief
       (see attachment 2) prepared by the individual or office seeking Council
       evaluation.
    6. A Council meeting will be convened.
             Experts from CDER and Agency staff will be sought and invited to
               participate in the discussion.
             The individual and/or office seeking Council evaluation will provide a ten
               minute overview of the medical policy issues at the beginning of the
               meeting.

Originating Office: Office of Medical Policy
Effective Date: 03/19/13                                                         Page 5 of 10
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