The Center for Drug Evaluation and Research (CDER) is responsible  for overseeing drugs and certain therapeutic biologics. Nonetheless, FDA officials acknowledged the growing need for strategic  planning across the medical product centers to improve center  collaboration and address emerging issues, but said that it may not  require a separate strategic plan. For example, officials said that  collaboration could help the centers develop more effective clinical trials,  improve their decision-making, and improve the quality of evidence and  clarity of guidance. FDA officials said that they did not structure the SIMP as a strategic plan,  because they thought it would be duplicative of other FDA strategic plans;  however, we found that none of these other plans comprehensively  describes FDA’s long-term plan for addressing key issues amongst the  centers, as summarized below:
FDA has an overarching strategic priorities document that includes  strategic goals and objectives for medical product activities. This  document describes a broad level of activities, but does not  specifically discuss strategies across the centers. The absence of a documented long-term plan for medical  product oversight may hinder FDA’s efforts to address emerging issues  that require center collaboration, such as access to quality data and  developing requirements for combination products. Also, the absence of a  documented strategy is inconsistent with leading practices for strategic  planning based on prior GAO work. Documenting a strategic plan for  medical products—whether it occurs in a freestanding document or as  part of existing documents the centers are already using—would also  enable FDA to oversee its activities in a consistent and transparent  manner, help the agency communicate its priorities to key stakeholders,  and help align its activities to support mission-related outcomes. FDA had fully implemented about a third of the efficiency  initiatives and most of the workforce development initiatives prior to the  SIMP’s issuance in 2013. FDA’s Strategic Integrated Management Plan Included User Fee and Center Initiatives to Improve Efficiency, About a Third of Which Were Implemented Prior to the Plan’s Issuance

We found that FDA grouped the SIMP’s 30 efficiency initiatives into three  themes: (1) business modernization, (2) process improvement, and (3)  smarter regulation. We found that FDA fully implemented about a third of the 30 efficiency  initiatives within the 12 to 18 months prior to the SIMP’s issuance in July  2013, and implemented another half of the initiatives since then. As of  March 2016, the remaining initiatives had yet to be fully implemented, the  majority of which are related to developing data standards for electronic  submissions or efforts to move to an electronic review process. FDA Included Different Types of Workforce Development Initiatives for Each Center, and Most Initiatives Were Implemented Prior to the Strategic Integrated Management Plan’s Issuance

We found that FDA included 19 workforce development initiatives in the  SIMP—11 training initiatives, 7 recruitment initiatives, and 1 retention  initiative. By  March 2016, FDA implemented 2 additional workforce development  initiatives, bringing the total to 17 initiatives. For the SIMP’s workforce  development initiatives, FDA identified mechanisms to assess most of the  19 initiatives, and each center’s approach to assess training is different. FDA Identified Formal and Informal Mechanisms to Evaluate the Effectiveness of Just Over Half of Its Efficiency Initiatives

FDA stated that the agency had assessed or has plans to assess just  over half of the 30 efficiency initiatives for effectiveness, although these  plans are generally not described in the SIMP. For five initiatives, FDA officials identified formal measures of  effectiveness that were not described in the SIMP. The officials explained  that these initiatives are assessed through periodic user fee program  reports or center strategic goals. FDA officials told us that, for the remaining 13 effectiveness initiatives in  the SIMP, they are either exploring effectiveness measures or do not  have plans to measure effectiveness. FDA Identified Mechanisms to Assess Most of the Workforce Development Initiatives, including Centers’ Different Approaches to Assess Training

FDA identified mechanisms to assess the effectiveness of 12 of the 19  workforce development initiatives. FDA officials described the mechanisms in place to assess the  effectiveness of 4 of the 7 recruitment initiatives described in the SIMP. However, FDA has faced  longstanding challenges in carrying out the many responsibilities  necessary for the oversight of medical products. Recommendation for Executive Action

To ensure that FDA can effectively coordinate and integrate its medical  product centers’ programs and emerging issues, we recommend that the  Secretary of Health and Human Services direct the Commissioner of FDA  to engage in a strategic planning process to identify challenges that cut  across the medical product centers and document how it will achieve  measurable goals and objectives in these areas. At that time, we will send copies to the Secretary of Health and  Human Services. Appendix III: Size and Characteristics of FDA and Medical Product Center Workforce, Fiscal Years 2012 to 2015

We analyzed Food and Drug Administration (FDA) data on the agency’s  workforce population and attrition for fiscal years 2012 to 2015.
Why GAO Did This Study

FDA—an agency within the Department of Health and Human Services (HHS)—has faced challenges in carrying out its responsibilities to ensure the safety and efficacy of medical products sold in the United States. In 2012, Congress required FDA to develop a SIMP for the three centers overseeing medical products that identifies initiatives for improving efficiency, initiatives for workforce development, and measures for assessing the progress of these initiatives. FDA issued the SIMP in July 2013.
GAO was asked to examine FDA's implementation of the SIMP. In this report, GAO (1) evaluates the extent to which the SIMP serves as a strategic planning document, (2) describes the types of plan initiatives, and (3) describes the mechanisms FDA has to evaluate the effectiveness of its plan initiatives. GAO analyzed FDA documents and spoke to FDA officials to assess the SIMP's development and use, along with the implementation status and evaluation mechanisms used for the SIMP's initiatives. GAO also assessed FDA's plan against leading practices for strategic planning. Finally, GAO analyzed FDA workforce data on hiring and attrition for fiscal years 2012 to 2015.

What GAO Found

The Food and Drug Administration (FDA) developed a strategic integrated management plan (SIMP) for its three centers that oversee medical products (biologics, drugs, and medical devices); however, GAO found that the plan does not incorporate leading practices for strategic planning or document a comprehensive strategy for the centers. FDA officials explained that circumstances at the time of the SIMP's development, including leadership gaps, limited FDA's ability to structure the plan into an effective strategic planning document. While officials said they use a variety of other key documents for strategic planning—such as agency-level and initiative-specific plans—these other plans also do not describe a long-term strategy for addressing key issues that cut across medical product centers. For example, these other FDA documents do not describe the agency's plans for collaboration between the centers that could benefit certain initiatives, improve their decision-making, and improve the quality of evidence and clarity of guidance. FDA officials acknowledged the growing need for strategic planning across the medical product centers to improve center collaboration and address emerging issues. The absence of a comprehensive long-term plan for medical product oversight may hinder FDA's efforts to address emerging issues that require center collaboration, such as access to quality data. Fully documenting such a strategy, either in a separate plan or through existing documents, would help the agency identify measurable goals and objectives for the centers that align with its mission and help communicate its priorities to key stakeholders.
In the SIMP, FDA compiled mostly preexisting initiatives to improve the efficiency of each center's activities and develop its workforce. GAO found that for improving efficiency, FDA selected 30 initiatives that it grouped into three different themes—smarter regulation, process improvement, and business modernization. FDA had fully implemented a third of the initiatives prior to the SIMP's issuance in 2013; another half were implemented by March 2016. As of this date, the remaining initiatives had yet to be fully implemented. For workforce development, FDA included 19 recruitment, retention, and training initiatives, which generally reflected differences in center activities. FDA implemented 15 initiatives prior to the SIMP's issuance and 2 additional initiatives since then. Of the remaining initiatives, 1 was terminated and, as of March 2016, FDA was in the process of implementing the other initiative.
Although not generally reported in the SIMP, FDA officials identified mechanisms to assess the effectiveness of the majority of the initiatives included in the plan. Of the 30 efficiency initiatives, FDA officials identified 8 that have formal evaluations (such as third-party assessments) and 9 that are assessed informally (such as by gathering feedback). For the remaining 13, officials said they are either exploring effectiveness measures or have no plans to assess them because they consider it to be unnecessary or impractical. FDA identified mechanisms to assess 12 of the 19 workforce development initiatives, including through recruitment performance metrics and surveys of training participants. For 4 initiatives, the centers each use different approaches to assess training. For the remaining 3 initiatives, FDA either is developing a mechanism or described past assessment activities.

What GAO Recommends

GAO recommended that the Secretary of Health and Human Services direct FDA to engage in a strategic planning process to identify challenges that cut across the medical product centers, and document how it will achieve measurable goals and objectives in these areas. HHS agreed with the recommendation.