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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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10-10 - EXPERT SUPPORT FOR CASES

10-10 - EXPERT SUPPORT FOR CASES
      10-10-1 - Purpose
      10-10-2 - Responsibility
      10-10-3 - Criteria For Determining The Level Of Expert Support
      10-10-4 - Documentation
      10-10-5 - List Of Individuals For Expert Support
      10-10-6 - Obtaining And Paying For Expert Support

  10-10 - EXPERT SUPPORT FOR CASES

  10-10-1 - Purpose

This section sets out a procedure for assuring that medical, scientific, technical or other specialized (collectively "expert") support is available for a case. A witness qualified as an expert by knowledge, skill, experience, training or education, may testify thereto in the form of an opinion or otherwise, if (1) the testimony is based upon sufficient facts or data, (2) the testimony is the product of reliable principles and methods, and (3) the witness has applied the principles and methods reliably to the facts of the case (Federal Rules of Evidence, "Rule 702. Testimony by Experts").

For purposes of this section, the term "case" refers to a matter that is or may become a court case or hearing. The term "experts" is used to describe individuals from within or outside of FDA, who may serve as consultants and/or as expert witnesses in a case. FDA may seek expert support whether or not a case is contested or litigated.

  10-10-2 - Responsibility

The Centers have the primary responsibility for assuring that FDA has appropriate expert support for a case, if needed to support the particular violation.   The initial determination as to the need for expert support shall be included in the approval memorandum.   The Center Compliance Office, in consultation with OCC, should determine whether or not FDA needs expert support for a case. If the Center determines that expert support is needed, it should consult with its medical or scientific review staffs to ensure that the Center position on the subject represents the consensus of current informed medical or scientific opinion. If necessary, the Center should also consult the Office of Regulatory Affairs (ORA) district offices to make this determination (see also FDA Staff Manual Guide 2610.2, Obtaining Services of Expert or Fact Witnesses (7/2/98)).

The Center should also determine whether FDA will be able to obtain expert support for a case, when it is necessary to do so. The Center should not send a case forward to institute actual legal proceedings until it makes these determinations about expert support.

  10-10-3 - Criteria For Determining The Level Of Expert Support

FDA requires outside expert support in precedent-setting cases when FDA does not have sufficient in-house expertise. If in-house experts are available, the Center should contact them to determine whether it should also contact individuals from outside FDA to assess the consensus of current medical, scientific, or technical opinion.

The Center generally should review unprecedented issues and complex cases involving state-of-the-art and/or current good manufacturing practice to determine whether it should obtain concurrence by the experts.

The Center generally needs only limited additional expert support for cases that are sufficiently similar to previous cases, except where a new court decision, regulation, or policy has sufficiently changed the factors to consider.

The Center generally needs to refer only to recent cases when determining the need for expert support in a current case that is identical to a recent case.

  10-10-4 - Documentation

The Center’s approval memorandum for a case should include a section regarding expert support, under a separate heading. This section should summarize the Center’s effort to provide assurance of expert support and describe significant issues or concerns related to the expert support. It should also include relevant information about prior or pending court cases, testimony or affidavits developed during a recent court case or hearing, information derived during recent processes to propose or finalize rules, advisory committee meetings, literature searches that support the consensus of current opinion, memoranda of conversations with experts, etc.

  10-10-5 - List Of Individuals For Expert Support

The Center should develop and maintain a list of experts. The Center might develop this information from a variety of sources, but it is responsible for assuring the adequacy of the expert support for a case. For example, when the Center contacts an expert, it should consider asking that expert to identify other individuals with similar expertise. This may be useful in the case at hand (e.g., if a corroborating witness is needed) as well as in future cases.

  10-10-6 - Obtaining And Paying For Expert Support

The Center might determine that FDA needs expert support from outside FDA to review a case and/or to serve as an expert witness. In that event, the Center should consult with other FDA components, e.g., Office of Chief Counsel and ORA district offices, to identify the most suitable witness, obtain the services of that individual, and pay for fees. Further background about obtaining the services of experts and paying for expert support is set out in an August 25, 2003, memorandum from Donald Vasbinder, Acting Director, Office of Enforcement, to FDA Center and ORA managers. A copy of the memorandum can be found on the Office of Enforcement’s intranet web site.

As explained in that memorandum, it is important to keep in mind the overall principle that each case is brought on behalf of the FDA, not any particular part of the organization. It is the responsibility of all involved elements of the FDA to cooperate and work together to provide the best possible support for all cases, regardless of which particular office may be the lead. Thus, it is the joint responsibility of the Center and field offices to identify and obtain the best witnesses and other case support, with the Office of Chief Counsel responsible for the final determination of use of witnesses if we anticipate a contest or litigating a case. Although the Centers have primary responsibility for assuring the availability of expert support, field offices should work closely with the Centers and provide any possible assistance in the process, such as identifying and suggesting to the Center possible good local experts. Field/Center consultation and cooperation on considering the possible need for and the obtaining of expert support should start as soon as necessary and feasible in the case development process and continue throughout each stage.

The following procedures are to be followed for obtaining and paying for the services of experts when needed for support of court cases or hearings:

  1. Decisions are to be made jointly by the responsible Center and field offices on the type and scope of expert support needed for support of cases and hearings. It is also important that, if the Agency anticipates that a case will be contested, the Office of Chief Counsel be consulted as to the use of expert witnesses. The office that first identifies the need to obtain expert support is responsible for contacting and consulting with the other offices responsible for the case.
  2. For outside (non-FDA) consultants and expert witnesses agreed upon as necessary by all parties to support cases or hearings at any stage (including support for a recommendation, review and approval, and litigation), all costs associated with such services will be shared equally among each major office (other than OCC) having responsibility for the case (e.g., each Center and District involved). This includes all necessary expenses for such expert services, such as contracting for and consulting with experts, travel and per diem, and other associated expenses necessary for this purpose.
    1. For outside experts, the responsible Center and field offices involved shall also consult and agree with one another on which office will be designated to take the lead role in actually contacting the expert, negotiating a contract for services, and making sure the necessary paperwork is completed.
    2. Normally, unless mutually agreed otherwise, the designated lead office for these administrative purposes will be the one having primary responsibility for the aspect of the case that requires the expert support. For example:
      1. The District would normally be the administrative lead for expert support (such as declarations) required for its regulatory action recommendations, or for expert witnesses needed for testimony for a trial or hearing under the District’s purview.
      2. The Center would normally be the administrative lead if either the Center or OCC concluded in reviewing a recommended case that outside expert review is required to ensure adequate scientific support is available before proceeding with the case, or for expert witnesses needed for testimony at a hearing under the Center’s purview.
    3. The designated lead office that prepares the necessary paperwork to procure the services for outside expert support is also responsible for ensuring timely payment of all invoices related to the services provided. In order to accommodate the shared-funding arrangement, the following accounting procedures should be employed:
      1. When an ORA field office is designated as the lead for an outside expert:

        The total expense should be charged to the applicable ORA field central funding CAN using category E. Accounting technicians should code field "N" of the DHR as follows:

        "E (Last name of witness)"

        Copies of each obligating document, including information concerning the Center with which the cost will be shared, should be faxed to ORA’s Office of Resource Management, Division of Management Operations (DMO) at (301) 827-1679. DMO will provide the respective Center a copy of the obligating document for tracking purposes. Each quarter, DMO will contact the budget personnel in the applicable Center to request a transfer of funds to recover half of the total cost.

      2. When a Center is designated as the lead for an outside expert:

        The total expense should be charged to the applicable Center’s accounting point. Copies of each obligating document, including information concerning the field location with which the cost will be shared, should be faxed to ORA’s Office or Resource Management, Division of Management Operations (DMO) at (301) 827-1679. Each quarter, the applicable Center will contact the budget personnel in DMO (301-796-4343) to request a transfer of funds to recover its half of the total cost.

  3. For expert support provided by FDA employees, all such expenses (including travel and per diem) will be borne by the office of the employee involved. Expenses should be paid by the employee’s office in accordance with its normal procedures. (NOTE: For expert support by FDA employees, this changes some provisions in sections 5.b. and 7.b.iii. of Staff Manual Guide 2610.2, which are somewhat in conflict.)