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9 assessment of.resources; (1-2) and, FDA must apply the mission statement and priorities in its daily operations (1-3). I totally agree. The mission of FDA has grown by leaps and bounds over the last 10 years. It is important for an organization to pause periodically and rethink where they are and where they need to be. We certainly cannot let more time elapse before we take this step. • Manaaement Svstems In the category of management, the Committee recommended that: The Commissioner clarify the roles of the Agency's organizational components and their senior managers, including clear standards of performance and accountability (5-1) . It also recommended: % FDA develop better ways to develop capabilities of its managers including scientists who assume managerial responsibilities (5-2) ~ Again, I endorse these management principles. A proposal to reorganize the senior management of the Agency is currently under consideration. It would reduce the number of officials who report directly to the Commissioner and enable him to get more involved in the diverse policy issues of FDA. A decision on this ~ ~ reorganization proposal will be made soon. Cn a

10 The organizational and management structure will also benefit from the Senior Biomedical Research Service, a measure passed last year by Congress allowing special scientific positions with increased pay schedules to enable FDA and other agencies to recruit and retain the skilled talent necessary to get the job done. S Another recommendation suggests that: FDA develop adequate management information systems (5-3). I recognize and support the need to develop sophisticated computerized data capability at FDA. This need is especially great for the inspectors and investigators in the field who are on the front lines of enforcement for FDA. Resources On the subject of FDA repources, the Committee recommends: FDA begin now to correct the most urgent of its facility needs, particularly for foods and veterinary medicine laboratories and field operations (6-1); and ~ The Commissioner must have full authority and adequate funding to develop better and more consolidated facilities, including ways to utilize innovative lease-purchase ~ O strategies (6-2). ~ C?7 CD C.~ ~ CO 00 . ~ <</

• • 11 I recognize and appreciate the support and leadership of this Committee in this area, especially in moving the FDA Revitalization Act through the last Congress. On recommendations dealing with facilities, I support the consolidated facility concept. However, as the Committee points out, and I agree, we cannot ignore the short-term need to upgrade some laboratories and facilities. I intend to have the Commissioner devise a priority plan for dealing with the repair and upgrading of certain facilities over the next five years, particularly in FDA's field offices around the country. However, I also want to indicate my interest and willingness to work with Congress to develop an innovative and longer term solution to this serious problem. Enforcement With respect to enforcement policy, the Committee recommends: Congress consider ways to streamline, expand, and modernize the range of available enforcement tools (4-1). and ~ FDA must enhance priority setting in its enforcement and identify enforcement areas lacking adequate resources. More effective strategies are needed to improve the efficiency of ZND O compliance programs, including those for low-priority areas. W~A- FDA must develop clear and precise regulatory guidance as an ~ ~ i~

• • 12 essential mechanism for promoting voluntary compliance (4-2) I agree with each of these recommendations. Also, I concur that FDA could benefit from some legislative enhancements in the enforcement area. An FDA investigator needs the same number and range of enforcement tools at his or her disposal as other investigators have. A proposal which would add to FDA's enforcement tools is presently under review in the Administration. In addition, we intend to work with Congress as it considers other legislation relevant to FDA enforcement such as debarment legislation. Leaislative In the legislative arena, the Committee recommends: Congress consider the full resource implications of all new legislation affecting FDA and allow for ways to delay or make discretionary -.~he implementation of lower priority programs (2-1) and, The FDA Commissioner and the Secretary must exert stronger leadership with Congress to address the imbalance between ~ FDA's statutory responsibilities and its appropriated resources (2-2). We simply cannot expect the FDA to operate well if additional ~ resources do not accompany new legislative responsibilities. On O +~ both a staff and agency head level, we are working more closely OS ~ C~:

• • 13 with Congress than ever before. Yet, ultimately Congress will have to be the custodian of this recommendation. In order to improve the balance between FDA responsibilities and available resources, I urge that you as Members of the key Senate authorizing Committee work closely with your colleagues on the Appropriations Committee to authorize FDA user fees as appropriate. Over the long term, user fees are an essential means of improving FDA's ability to fulfill new legislative requirements as well as its basic mission. Conclusion I have discussed a number, but certainly not all, of the 29 recommendations contained in the Advisory Committee Report. Although I have only officially received this Report today, I can, at first glance, agree with many of its recommendations. Other recommendations will require more time for a careful reading. I expect that we will be moving forward on many of these in the near future. There may be a few recommendations, of course, that I would not support at this time or would not support without further information or evidence. in many instances, changes are underway at FDA and within the Public Health Service and the Department in accordance with these recommendations. I have asked Dr. Mason to work closely with Dr. Kessler to ensure that as many of the Report recommendations as possible are implemented as expeditiously as possible. I plan 0

• S 14 to take the blueprint provided in this Report and move the FDA forward. In conclusion, I believe the Report is an excellent document that will guide policy decisions on FDA issues for many years, and I again commend Dr. Edwards and members of the Committee for their superior work and diligence to the mission. This concludes my comments. I will be pleased to respond to any questions you have. 4, lv 0 V .' W 00 . ~`