The IOM committee deliberated at length about recommending that FDA adopt a policy of scheduling advisory committee meetings as long as one or even two years in advance. Meetings scheduled in this way would require the following associated deadlines: agency (and presumably sponsor) agreement to review an application at a scheduled meeting; timely sponsor submission of all data to go to the advisory committee; timely completion by the agency of its review; and on-schedule distribution of material to the advisory committee members.

The proffered referent in this case is the submission of a research grant proposal to the National Institutes of Health (NIH) by a specified date to ensure its review at a particular time. Included in this scheme is a decision rule that late applications are not reviewed until the next cycle. Although the committee recognizes that the NIH experience provides an imperfect comparison for the submission and evaluation of an application to the FDA, it believes that there is great merit in introducing some comparable discipline in the FDA review process.

At least three reservations about such a proposal have been expressed. First, scheduling conflicts with major professional society meetings could occur. This is the least serious problem and could be handled similarly to NIH procedures. (NIH schedules grant proposal cycles and study section meetings one or two years in advance and consults with the major professional societies in particular fields before doing so.)

Second, in informal discussions industry representatives responded favorably to advance scheduling provided the particular advisory committee met at least three times per year and on a regular basis. The "cost" of three or four months delay if a meeting deadline were missed under such circumstances was seen as tolerable. Indeed, working to deadlines elicited a generally favorable industry response. However, for those advisory committees that met only twice a year, failure to meet the associated deadlines would result in a slippage of six months; the industry representatives did not find this period acceptable.

The most serious reservation was voiced by FDA representatives, who expressed the view that establishing a certain date some 6 to 12 months in advance for the end of an FDA review would be very difficult. Furthermore, meeting such advance deadlines would impose a demand on scarce agency resources of medical reviewers, which would make it difficult for the agency to comply easily.

The IOM committee saw the benefits of advance scheduling as twofold: imposing greater discipline on the internal product evaluation process, and making it easier to schedule the time, and thus ensure the participation, of

Front Matter (R1-R12)

Summary (1-32)

1 Introduction (33-45)

2 Historical Evolution of FDA Advisory Committees (46-69)

3 The FDA Advisory Committee System (70-99)

4 Recurring Issues (100-115)

5 Committee Membership (116-126)

6 Ensuring Committee Integrity (127-172)

7 Committee Operations (173-195)

8 Organization and Management (196-214)

A Resource Implications (215-221)

B Glossary (222-227)