LaTonya M. Mitchell District Director, Denver District Director Office of Regulatory Affairs Office of Global Regulatory Operations & Policy U.S.

Transcription

1 LaTonya M. Mitchell District Director, Denver District Director Office of Regulatory Affairs Office of Global Regulatory Operations & Policy U.S. Food and Drug Administration 1

2 Office of the Commissioner Office of Foods and Veterinary Medicine Office of Medical Products & Tobacco Office of Global Reg. Ops & Policy Center for Food Safety & Applied Nutrition Center for Veterinary Medicine Center for Devices & Radiological Health Center for Biologics Evaluation & Research Center for Drug Evaluation & Research Center for Tobacco Products Office of Regulatory Affairs Office of International Programs 2

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5 Southwest Region 5

6 Denver District Office 6

7 About Program Alignment On September 6, 2013, former U.S. Food and Drug Administration (FDA) Commissioner Margaret Hamburg, M.D. charged a group of senior leaders with identifying and developing plans to modify functions, processes and structures to meet greater agency demands by facilitating increased operational and program alignment. Scientific Innovation FDA Challenges and Demands New Legal Authorities Globalization Increasing Complexity Of Regulated Products 7

8 Charting a Course to Modify FDA Functions On February 3, 2014, former U.S. Food and Drug Administration (FDA) Commissioner Margaret Hamburg, M.D. charts a course for modifying Agency functions and processes to improve communication and collaboration and to clarify roles, responsibilities and decision rights across all Agency components. Decisions for Implementation Next Steps Core Set of Operational Changes 8

9 Program Alignment Action Plans FDA s directorates, centers and the Office of Regulatory Affairs collaborated on a set of six fiscal year 2015 Program Alignment Action Plans to define ways to transition the agency to distinct commodity-based and verticallyintegrated regulatory programs. Key areas in this multi-year effort include specialization, training, work planning, compliance policy and enforcement strategy, imports, laboratory optimization and information technology. Tobacco Food and Feed Bioresearch Monitoring Program Alignment Action Plans Pharmaceutical Quality Medical Devices and Radiological Health Biological Products 9

10 Action Plan Highlights: Expand Compliance Tools ORA field investigators will work with subject matter experts from the Center for Food Safety and Applied Nutrition and the Center for Veterinary Medicine to make decisions in real time. We will work with firms to achieve prompt correction of food safety deficiencies to help implement the preventive approaches outlined by the FDA Food Safety Modernization Act. If industry does not quickly and adequately correct critical areas of noncompliance that could ultimately result in food borne outbreaks, we will use our enforcement tools, including new tools such as those provided under FSMA, as appropriate. 10

11 Action Plan Highlights: Jointly Develop New Inspection Approaches The Center for Drug Evaluation and Research and ORA are piloting a new paradigm for inspections and reports to advance pharmaceutical quality, standardize our approach to inspection data gathering to inform quality intelligence of sites and products. The Center for Devices and Radiological Health and ORA plan, for example, will begin to focus some inspections on characteristics and features of medical devices most critical to patient safety and device effectiveness. ORA investigators will perform these inspections utilizing jointly developed training. 11

12 Action Plan Highlights: Imports Operations Determined ORA needs to increase import specialization and focus on national import strategies. We are working with the centers to better define risk modeling, and establish import strategies by commodity. Future: ORA may increase additional districts on U.S. borders by modeling the Southwest Import District. 12

13 Action Plan Highlights: Optimize FDA Laboratories ORA and the centers will establish a multi-year strategic plan for ORA scientific laboratory work. 13

14 Action Plan Highlights: Invest In Expanded Training Across ORA and the Centers Example: the Center for Biologics Evaluation and Research and ORA will jointly develop a biologics training curriculum, redesign investigator certification, and cross-train center and ORA investigators, compliance officers and managers. 14

15 Action Plan Highlights: Establish Senior Executive Program Directors in ORA For example, in the past the Center for Drug Evaluation and Research would work with several ORA units responsible for the pharmaceutical program. Now, the centers will have a single operational Senior Executive in ORA responsible for each commodity program, allowing ORA to streamline decision making and operations. 15

16 ORA s Approach to Increased Specialization ORA s current district structure will remain the same, but align to commodity areas with operational management and staff specializing in a program. The current Regional Food and Drug Director positions will become Program Executives responsible for each commodity area. 16

17 Specializing ORA s Operational Staff Movement from our geographically-based management to a program-based management model will increase opportunities for staff. Investigators, compliance officers and operational managers will specialize in a single program area. Specialized Inspectorat e New Skills & Disciplines Increased Technical Knowledge Targeted Hiring 17

18 Next Steps In FY15 ORA managed each Program Alignment Action Plan as a project with crossagency team members to ensure we fulfilled our commitments. In FY16 we will begin to transition to the specialized management model and assign operational staff a commodity program area, and execute action plans with each center. Implementing the new specialized management model and our action plans will take time, commitment, and continued investment and the organization will continuously monitor and evaluate its efforts. 18