Working With FDA to Develop Policy

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Working With FDA to Develop Policy

• By Bradley Merrill Thompson
• Epstein Becker Green P.C.
• December 6, 2007

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Agenda

• Stakeholder Objectives
• Overview of the Administrative Laws
• So Whats Possible?
• Some Case Studies

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Industrys Objectives in Policy Making

• The right policy prevailsin our eyes
• Earliest possible discussion
• Informality can be good
• A two way street is helpful
• An enduring discussion
• The right evidence is used
• Privacy might be necessary
• Rebuttal opportunities
• A few bites at the apple is nice
• Speed can be good or bad

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The Agencys Objectives

• The right policy prevailsin their eyes
• Justice
• Low personal risk
• Using a process that can be defended
• Legally
• Politically
• Efficiency
• Informality can be good
• Access to the right information
• Speed is usually good
• Instills confidence
• Sets the stage for compliance and enforcement

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Objectives behind Administrative Laws--
Rulemaking

• Ensure rules are
• Thoughtful
• Well-supported by a factual record
• Unbiased by special interests
• The process is fair for all concerned
• Enhanced compliance because those concerned had
  the opportunity to provide input

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Objectives behind Administrative Laws--FACA

• Counter the undue influence of special interests
  by ensuring that the membership of federal
  advisory committees is balanced
• Ensure the committee meetings and minutes are
  open to the public
• There were too many inactive, meaningless,
  obsolete and redundant committees
• At the same time, other committees were so
  powerful they, in effect, constituted a fifth
  arm of government

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Objectives behind Administrative Laws--GGPs

• No announcement of policy through speeches and
  enforcement letters
• No policy development without public input
• No confusion regarding official policysign off
• Need for systematic process for keeping guidance
  up to date
• Need for central repository
• Clarity regarding the legal effect of guidance

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Tensions in Objectives

• Speed vs. Openness
• Universal fairness vs. informality
• Early collaboration vs. universal fairness
• Creativity vs. procedural fairness
• Privacy vs. fairness
• Efficiency vs. fairness

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Agenda

• Stakeholder Objectives
• Overview of the Administrative Laws
• So Whats Possible?
• Some Case Studies

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Government in the Sunshine Laws

• Federal Rulemaking (APA)
• Federal Advisory Committee Act
• 21 C.F.R. Part 10 FDA Administrative Practices
• Good Guidance Practices
• OMB Regulations and Guidelines

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Choice Between Rulemaking and Guidance
Development
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Federal Rulemaking

• Types of rulemaking
• Formaltrial type
• Informalnotice and comment

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Notice and Comment Rulemaking Process

• Notice of proposed rulemaking in FR (optional)
• Proposed rule with explanation published in FR
• Comment period (discretionary)
• Agency analysis
• Final rule published in FR, together with
  statement of basis and purpose
• Judicial review available

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Guidance Development

• Similar dichotomy to rulemaking
• Level 1 is reserved for guidance that
• Plows new ground
• Addresses controversial topics
• Makes significant policy changes or
• Tackles complex science.
• Level 2 is used for all other guidance

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Guidance Development Process

• Similar to rulemaking, but uses FDAs website
  instead of FR
• Only employs the FR to announce level 1 guidance
• Level 1 guidance requires an opportunity for
  public comment before implementation
• Level 2 does not
• Meant to be less formal than rulemaking, and to
  allow early collaboration

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Federal Advisory Committee Act

• FACA requires that advisory committees
• Establish a written charter that explains the
  mission of the committee
• Give timely notice of meetings in the FR
• Have fair and balanced membership
• Open meetings to the public whenever possible
• Have the sponsoring agency prepare minutes of
  meetings
• Provide public access to the information used by
  the committee
• Grant to the federal government the authority to
  convene and adjourn meetings
• Terminate within two years unless the committee
  charter is renewed or otherwise authorized by
  statute

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FACA Applicability
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Some Popular Misconceptions Debunked

• Informal rulemaking does not preclude contact
  between the agency and the public
• Even clearer before the proposed rule is
  published
• But it is wise to keep records
• Also, FDA cannot give advanced notice of what is
  in a proposed rule (fairness issue)
• Guidance develop rules contain absolutely no
  restrictions on meetings with the public
• The FR notices announcing the GGPs explained the
  goal of facilitating early communication

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Agenda

• Stakeholder Objectives
• Overview of the Administrative Laws
• So Whats Possible?
• Some Case Studies

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Wide Range of Options for Meetings

• Public meetings, including FDA workshops,
  conferences etc. ( 10.65(b))
• Private meetings with specific industry groups on
  FDAs premises where summaries are filed with
  the comments (10.65(d))
• Industry hosted meetings that FDA attends, like a
  trade associations annual meeting ( 10.65(e) )
• Standards activities organized by appropriate
  standards development organizations such as AAMI
  ( 10.95)
• Capitol Hill-convened meetings
• Meetings convened by a neutral third party (e.g.,
  FDLI)
• Written communication, either e-mail or other
  correspondence (10.65(f))
• Discussion as part of an advisory committee
  meeting

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Technologies Available

• Telephone conference calls
• Video desktop conferencing
• Electronic chat rooms
• Internet broadcasts of various types

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Agenda

• Stakeholder Objectives
• Overview of the Administrative Laws
• So Whats Possible?
• Some Case Studies

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FACA Case Study One

• Suppose FDA decided to hold a town meeting to
  provide a one-time forum for any interested party
  to voice its opinions and concerns to the agency
  on the appropriate design of a clinical trial to
  support a PMA.
• The time and place of the meeting were determined
  in advance
• The costs of the meeting -- the rental price of
  the meeting place, for example -- were paid by
  the agency
• FDA publicized its meeting in advance on its
  website, inviting any parties interested in
  participating to attend

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FACA Case Study One Analysis

• Quite clearly, this conduct would not trigger
  FACA.
• The agency obviously did not utilize an existing
  group for advice or recommendations.
• Nor did FDA in the scenario establish the group.
  
• The town meeting took place only once, involved a
  group of participants not designated by the
  agency -- indeed not identifiable before the
  event -- and otherwise exhibited no
  organizational structure.
• Simply by holding the meeting the agency did not
  solicit the collective views, as opposed to the
  individual views, of those who attended.

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FACA Case Study Two

• Imagine FDA sought to gather the individual views
  of several recognized experts on the proper
  design of clinical trials.
• FDA decided to hold one long meeting on a single
  day and have all these experts meet with the
  agency personnel at once.
• At this one-time meeting, FDA personnel
  questioned the experts, one at a time.
• Each expert, in turn, explained to the agency her
  position regarding the clinical trial question.
• FDA personnel kept careful notes of each experts
  view.
• No time was reserved for a general discussion
  session among the experts.

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FACA Case Study Two Analysis

• Does not trigger FACA.
• The mere fact that the agency assembled the
  experts at once does not affect FACA's
  applicability where, as explained, the experts in
  no way interact or otherwise function as a unit
  or a group.

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FACA Case Study Three

• Imagine FDA sought a recommendation from AdvaMed
  about whether the agency should promulgate a new
  rule concerning the proper design of clinical
  trials for PMAs.
• To get AdvaMed's advice, the agency convened a
  series of meetings attended by the agency's own
  personnel as well as AdvaMed staff
• No other medical device group or consumer group
  was invited to the meetings
• Nor were individual company representatives
  invited.
• FDA and AdvaMed staff also happened to discuss
  the merits of the agencys policy on some
  closely-related issues involving PMAs

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FACA Case Study Three Analysis

• FACA would not apply.
• Although FDA solicited specific advice respecting
  a particular policy issue, the advice came from
  an independent, pre-existing group, not
  established by the agency.
• The important question would be whether FDA so
  tightly controlled AdvaMed that it utilized
  AdvaMed for the purpose of obtaining advice.
• But the agency exercised no control over AdvaMed,
  much less tight control.
• FDA invited AdvaMed to the meetings, but in no
  way did the agency shape AdvaMed's composition,
  management, perspective, deliberations, or agenda.

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FACA Case Study Four

• As in the first case study involving the town
  meeting, suppose now that the agency's meeting
  was so successful that FDA decides to
  institutionalize the event, and conduct it every
  few months.
• Over time, the number of attendees stabilizes to
  a group of 15 loyal regulars, who develop a sense
  of group rapport.
• FDA decides to use the group, repeatedly, as a
  sounding board for specific proposals the agency
  is considering.
• Before each meeting FDA sends out an agenda.
• At each meeting, those who attend are given a
  chance to address FDA about their own concerns,
  but time is always reserved for the agency to tap
  the views of those in attendance on the agencys
  issues.
• The group lacks formal organizational structure
  it has no chair, no secretary, and no minutes are
  kept at the meetings.

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FACA Case Study Four Analysis

• FACA may apply.
• Although the group has no formal structure, its
  membership is stable.
• The subject of discussion is prepared in advance
  of the meetings, and addresses topics which FDA
  itself identifies.
• Those topics include specific proposals under
  consideration at the agency.

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FACA Case Study Five

• Consider again the second case study involving a
  meeting of experts. Suppose that instead of
  seeking experts individual views, FDA sought the
  collective view.
• The agency still scheduled only one meeting, for
  the limited purpose of giving experts an
  opportunity to present their collective view.
• The meeting did not provide the experts with an
  opportunity to discuss the regulatory issue in
  question.
• Instead FDA instructed the experts to meet on
  their own time, without agency involvement.
• At the FDA meeting, the experts presented the
  agency with a sharply divided report containing
  the experts majority and minority views on the
  issue under the agency's consideration.

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FACA Case Study Five Analysis

• FACA may apply.
• Although no FDA personnel participated in the
  experts prior meetings, and although those
  meetings produced no consensus view, still the
  agency established a group composed of
  non-employees with the specific intent of
  obtaining advice on a particular question.
• The group of experts, who had no organization
  prior to their enlistment by FDA, met,
  deliberated and subsequently communicated their
  collective although divided advice to the agency,
  all of the agencys instigation.

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FACA Case Study Six

• Return to the example of where FDA invited
  AdvaMed. Now suppose that the agency, seeking
  the advice of the drug and medical device
  communities generally, created an entirely new
  group composed of representatives from leading
  trade associations.
• FDA scheduled a series of meetings for the new
  group's members to discuss whether the agency
  should promulgate a new rule to prescribe the
  proper design of a clinical trial, with the
  intention of relying on the group's advice.
• FDA designated the representative of one of the
  trade groups to serve as the groups Secretary,
  and another to be its spokesman.

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FACA Case Study Six Analysis

• FACA would apply.
• FDA's conduct now satisfies every item on the
  checklist of criteria for triggering the act.
• The agency
• established the group
• appointed all of its members
• gave it an organizational structure, and
• directed it to consider a substantive policy
  issue and to advise the agency about whether to
  respond to that issue.
• Although FDA could have solicited advice from
  individual group members speaking on behalf of
  their respective trade associations without
  utilizing those groups, the agency instead
  decided to establish a group.

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Comments or Questions?