Appendix A
Resource Implications*

The implementation of the IOM committee's recommendations in this report does not depend greatly on additional budgetary and personnel resources. Many recommendations involve policy determinations that will lead to procedural changes. The one-time ''costs" of the former will be absorbed by the agency's review of this report. The procedural changes, the committee believes, will result in greater effectiveness of the advisory committee system; some may also result in increased efficiencies.

This Appendix identifies five recommendations (or sets of recommendations) of the IOM report that will require additional monies or personnel. It provides a first approximation to the resource implications of those recommendations. It does not purport to be a technical cost estimate of all recommendations, as such an effort would require more data than are readily available and would dwarf the study itself. The analysis is preceded by a brief discussion of the costs of the current system.

CURRENT SYSTEM COSTS UNDERESTIMATED

Each year, the FDA prepares an Agency Summary on the fiscal year costs of all of its advisory committees, in compliance with the requirements of the Federal Advisory Committee Act (FACA). This report is the primary source of public information about the costs of FDA advisory committees and its data are used in the agency's budget submission to Congress. Table A-1 summarizes these data for fiscal years 1987 through 1991 in terms of the FDA's cost categories.

The committee management staffs of the three centers compile the data for the annual report in accordance with guidance from the FDA's Committee Management Office. Although most of the cost computations are

*  

This appendix is based on an analysis prepared by Rebecca Wallace.



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Food and Drug Administration Advisory Committees Appendix A Resource Implications* The implementation of the IOM committee's recommendations in this report does not depend greatly on additional budgetary and personnel resources. Many recommendations involve policy determinations that will lead to procedural changes. The one-time ''costs" of the former will be absorbed by the agency's review of this report. The procedural changes, the committee believes, will result in greater effectiveness of the advisory committee system; some may also result in increased efficiencies. This Appendix identifies five recommendations (or sets of recommendations) of the IOM report that will require additional monies or personnel. It provides a first approximation to the resource implications of those recommendations. It does not purport to be a technical cost estimate of all recommendations, as such an effort would require more data than are readily available and would dwarf the study itself. The analysis is preceded by a brief discussion of the costs of the current system. CURRENT SYSTEM COSTS UNDERESTIMATED Each year, the FDA prepares an Agency Summary on the fiscal year costs of all of its advisory committees, in compliance with the requirements of the Federal Advisory Committee Act (FACA). This report is the primary source of public information about the costs of FDA advisory committees and its data are used in the agency's budget submission to Congress. Table A-1 summarizes these data for fiscal years 1987 through 1991 in terms of the FDA's cost categories. The committee management staffs of the three centers compile the data for the annual report in accordance with guidance from the FDA's Committee Management Office. Although most of the cost computations are *   This appendix is based on an analysis prepared by Rebecca Wallace.

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Food and Drug Administration Advisory Committees Table 1 FDA's Advisory Committee Costs: Fiscal Year 1987 through Fiscal Year 1991 Data Elements 1987 1988   1989   1990   1991 Personnel Payments Nonfederal Members $65,849 $64,193 $77,391 $86,952 $101,963 Federal Staff 441,388 518,484 696,228 733,277 1,141,999 Nonmember Consultants 18,454 24,707 23,145 32,958 32,850 Subtotal 525,691 607,384 796,764 853,187 1,276,812 Total Travel and Per Diem 215,607 270,629 358,242 354,124 397,257 Other 75,815 78,194 113,484 139,235 157,506 Total 817,113 956,207 1,268,490 1,346,546 1,831,575 Total FTE Years 11.90 12.40   17.82   17.00   26.01 Note: FTE = full-time equivalent.

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Food and Drug Administration Advisory Committees straightforward, there is reason to believe that the reported costs are understated, especially those of personnel payments to federal staff. First, not all committee management salaries are included. Federal staff costs for all three centers include only those committee management staff who spend 10 percent or more of their time in direct support of advisory committee business. Moreover, CDER figures include only the salaries of executive secretaries and the committee management assistants; CBER payments exclude the secretarial support of its committee management staff. These costs do not include the other members of the committee management staffs. In addition, CDRH costs do not include the costs of a contractor ($95,000 in fiscal 1991) that provides support services to its device advisory committees. Also excluded are the staff of the Division of Ethics and Program Integrity who process conflict-of-interest waivers, and the FDA's Committee Management Office, which prepares the annual report on advisory committees. Beyond these omissions, the costs of division personnel, from medical reviewers through division directors, that might be allocable to advisory committee work are also excluded. RECOMMENDATIONS THAT WILL HAVE RESOURCE IMPLICATIONS Five recommendations of the IOM committee, if adopted, will require additional resources for which the incremental costs can be identified and calculated relatively easily. They are: (1) improving the management of the advisory committee system by appointing a high-level official in the Office of the Commissioner to provide management and administrative policy guidance to the system; (2) strengthening the process for recruiting advisory committee members; (3) establishing needed training and orientation efforts; (4) scheduling advisory committee meetings a year or more in advance, and reviewing the NDA and IND pipeline each year; and (5) possibly increasing advisory committee members' compensation. 1. Improving the Management of the Advisory Committee System The IOM committee recommendation that a high-level position be established in the Office of the Commissioner to provide management and policy guidance for the advisory committee system will require the FDA to devote one full-time senior staff position and at least part-time administrative support to this new function within the agency. Performing the tasks suggested by the panel will require an individual who works closely and on an even footing with center, office, and division personnel.

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Food and Drug Administration Advisory Committees 2. Recruiting Committee Members The IOM committee recommends that the recruitment process be organized in a systematic, formal, and aggressive way, with special attention to women and minorities. There are three potential sources of cost to increased recruiting efforts. First, it may be the case that one fun-time equivalent (FTE) in each center will be needed to perform the day-to-day responsibilities of recruiting (including routinely soliciting ideas for potential members from current and former advisory committee members; professional medical and scientific societies; medical school deans and department chairmen; and industry, consumer, and patient organizations); contacting appropriate professional journals; using the NIH-ADAMHA computerized file; and communicating with potential committee members to increase their interest in serving on a committee. Second, if the FDA pursues the option of creating and maintaining its own computerized data base of potential advisory committee members, the agency will incur additional costs. The NIH-ADAMHA system is an example of what such a system might cost. Most of the design and maintenance of this system is done by a contractor, who sends all the mailings, performs all data entry, makes minor program changes, offers six tutoring sessions on the system to the professional staff each year, maintains a users manual, responds to all questions on the system, and duplicates all CVs and provides them to requestors. The contractor is currently designing a program to put all CVs on-line. Original design costs for this contract are not known but current operating costs are $250,000 per year. The contractor uses one professional to manage the system and two or three staff for data entry and troubleshooting. In addition to the annual contract costs, an NIH project director spends 10 percent of her time monitoring the contract. ADAMHA, through an interagency agreement with NIH, contributes about $50,000 per year to the effort. Contract costs are expected to decrease as the data base becomes more complete and maintenance becomes more routine. The development of this system required the NIH to obtain clearance from the Office of Management and Budget to ask private individuals for personal data. Special permission was needed to ask for gender and race information. In addition, the NIH had to obtain Privacy Act clearance to store the acquired information. Third, in lieu of developing its own automated system, the FDA might enter into an interagency agreement to support the NIH system and seek to have it modified to meet its own special needs. The NIH, in August 1992, was forming a task force to recommend changes to the system.

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Food and Drug Administration Advisory Committees 3. Establishing an Orientation Program The IOM committee recommends that the FDA develop an orientation program consisting of an FDA-wide component, a center-specific component, and a division-specific component. It further recommends that this program be offered two or three times a year and that all new members attend within six months of their appointments. In addition, the committee recommended that the FDA develop a training program for its staff who deal with conflict-of-interest issues; this training effort could provide the basis for the conflict component of the orientation program. Course development would be an initial cost to the agency, and as FDA policies change, the material would need to be updated. According to an FDA staff member who has developed such programs in other agencies, designing a 3–6 hour course in-house would take about one-quarter of an FTE, or $15,000–$16,000. This amount would depend, of course, on the accessibility of materials and resources needed to develop the curriculum and the ease of reaching agreement on substance among the relevant senior FDA staff from the three centers. Once the course is developed, the additional costs of conducting the program would include advisory committee member compensation, travel, and per diem; FDA staff time; and space and facilities, supplies, and incidentals. Factors affecting costs include the frequency of orientation sessions, the specific FDA staff who will participate when and where the sessions are held, and what training methodology is used. If the FDA adopts the IOM recommendation to hold two or three orientation sessions in Washington, D.C., per year, separate from any scheduled committee meeting, new advisory committee members must make an additional trip to Washington. Assuming that one-quarter of the committees' staffs turns over each year, approximately 91 advisory committee members will require orientation each year. The estimated additional compensation to advisory committee members, travel, and per diem each year for 91 members are: member compensation for 2 days (at $150/day) travel and per diem for 2 days $27,300, 40,586. The logistical aspects of the sessions might require four to five days of FDA administrative staff time per session. The amount of professional staff time needed to run the orientation sessions will depend on the extent to which videotapes or other training methods can be used in lieu of face-to-face instruction. At a minimum, one staff member from each center would need to be present for each day of orientation.

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Food and Drug Administration Advisory Committees Regarding videotapes, the CDRH has approved three video scripts for use in its advisory committee orientation sessions: ''Mission and Organization"; "Medical Device Approval: the Process and the Panel's Role"; and ''Avoiding Conflict-of-Interest." Although the scripts were prepared by a contractor, significant FDA staff time was involved in providing input, reviewing the scripts, and, in some cases, rewriting them. Funding for the contractor of $10,000 was provided by the Health Industry Manufacturers' Association (HIMA). Production costs will range from $10,000 to $25,000 per videotape, depending on whether or not professional actors are used. 4. Scheduling Advisory Committee Meetings in Advance; Reviewing the NDA and IND Pipeline Annually The IOM committee recommends that the FDA establish a meeting schedule for each committee one year in advance. These recommendations have cost implications in terms of staff years for both center staff and committee management staff. Staff time within each center will need to be devoted to developing a meeting schedule for all committees one year in advance, and to continually reviewing what is in FDA's pipeline to revise that schedule as necessary. The potentially most significant additional cost to the agency to implement this recommendation may be the need for more FDA medical reviewers to complete reviews on a scheduled basis. This need is a matter that the agency will undoubtedly wish to examine carefully in its evaluation of this recommendation. 5. Increasing Compensation of Advisory Committee Members Although the IOM committee does not recommend an increase in compensation for advisory committee members, it urges the Commissioner to raise this matter with the Secretary of Health and Human Services. If the Commissioner does so, and if compensation is increased, there are obvious budgetary implications of such action. Below we compare the estimated cost to the FDA of three rates of compensation for advisory committee members in fiscal year 1991. These are the current rate of $150 per day and two hypothetical rates of $250 per day and $320 per day. The $250 rate is arbitrary but reasonable; the $320 rate is the maximum currently payable (GS-15, step 10) under GSA rules. The cost computations are based on 899 advisory committee member/consultant reimbursable days.

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Food and Drug Administration Advisory Committees Rate per Day Costs $150 $134,813 250 224,750 320 287,680 If the FDA were to pay for advisory committee members' homework, which it does not now do, save for clinical reviews by CDRH committee members, this would add to the costs of the system. Estimates follow of the incremental cost of allowing five days of homework per committee member (assuming an average of 10 members per meeting) at three different compensation rates, $150, $250, and $320 per day. The incremental costs range from $500,000 to $1 million a year. Rate per Day Costs $150 $480,000 250 800,000 320 1,024,000 The FDA's regulatory responsibilities are vast and the expertise needed to effectively carry them out are equally great. It is neither feasible or desirable to eliminate the use of advisory committees as a way to acquire some of that expertise. Thus, the FDA must commit resources to its advisory committee process. In relation to the FDA's total budget, the incremental costs of modifying the advisory committee system appear relatively modest when compared to the potential benefits that can be expected to accrue to the agency.