Within FDA, the Office of Medical Products and Tobacco is responsible for providing leadership for the medical product centers and coordinating their plans, strategies, and programs. Under the office’s direction, three FDA centers have primary responsibility for overseeing medical products and developing strategic plans to guide their activities: The Center for Biologics Evaluation and Research (CBER) is responsible for overseeing most biologics, such as blood, vaccines, and human tissues. The Center for Drug Evaluation and Research (CDER) is responsible for overseeing drugs and certain therapeutic biologics. The Center for Devices and Radiological Health (CDRH) is responsible for overseeing devices and for ensuring that radiation- emitting products, such as microwaves and x-ray machines, meet radiation safety standards. Several offices within FDA provide additional oversight and management support to assist the three medical product centers. FDA’s Office of Policy, Planning, Legislation, and Analysis supports strategic planning at the agency-wide, program-specific, and center levels across FDA, which included coordinating the development of the SIMP and FDA’s agency- wide strategic priorities document. FDA’s Office of Human Resources supports recruitment and workforce management activities. Finally, FDA’s Office of Regulatory Affairs conducts field activities for all of FDA’s medical product centers, such as inspections of domestic and foreign establishments involved in medical products. The centers conduct pre- and post-market oversight of medical products, as well as formulate guidance, perform research, communicate information to industry and the public, and set priorities. Premarket oversight comprises review activities to ensure that medical products are safe and effective for use before they can be marketed in the United States. FDA’s premarket oversight typically begins when companies— known as sponsors—develop a medical product. Before beginning clinical trials (studies involving humans) for a new medical product, sponsors must submit an application so that FDA can preliminarily assess the product for safety. As part of its premarket oversight, FDA may also choose to inspect establishments producing medical products to ensure their manufacturing processes meet quality standards. Postmarket oversight includes review activities to both provide certainty that medical products are safe and effective after they have been marketed, and to enable FDA to take regulatory actions if a safety issue is identified, such as requiring that sponsors communicate new safety information to the public and health care providers or withdraw the product from the market. Examples of postmarket oversight include reviewing reports of adverse events to monitor the safety of marketed medical products and examining advertising and other promotional materials to ensure they are not false or misleading. FDA may require sponsors to provide additional information both before and after a product has been approved. For example, FDA may require medical product manufacturers to create a Risk Evaluation and Mitigation Strategy to ensure that the benefits of a medical product outweigh its risks. A significant portion of FDA’s annual appropriation consists of amounts derived from user fees paid by the medical products industry. Beginning in 1992 with prescription drugs, Congress has authorized the collection of user fees from the medical products industry to provide additional resources for certain FDA oversight activities. Each user fee program is subject to reauthorization every 5 years and supports different oversight activities across each of the centers, as illustrated in figure 1. In 2012, FDASIA reauthorized or authorized four user fee programs for medical products. It included the fifth reauthorization of the Prescription Drug User Fee Act of 1992 (PDUFA), which allows FDA to collect user fees from manufacturers of prescription drugs. It also included the third reauthorization of the Medical Device User Fee and Modernization Act (MDUFA), which allows FDA to collect user fees from manufacturers of medical devices. Congress also authorized two new user fee programs in FDASIA: the Biosimilar User Fee Act (BsUFA), and the Generic Drug User Fee Amendments Act (GDUFA). BsUFA authorizes FDA to collect user fees from manufacturers of biosimilars, which FDA may approve based on a sponsor’s ability to show that the product is highly similar to an FDA-approved biological product and has no clinically meaningful differences in terms of safety and effectiveness. GDUFA authorizes FDA to collect user fees from manufacturers of generic drugs. Prior to each user fee program reauthorization, FDA negotiates with representatives of each medical products industry to identify goals for how FDA should spend those user fees over the next 5-year authorization period. Once FDA and the industry reach agreement, the Secretary of Health and Human Services submits letters containing these commitments to Congress. The user fee commitments contain performance goals for FDA’s review activities, such as reviewing and acting upon a certain number of received medical product applications within certain time frames. User fee commitments may also require FDA to undertake certain actions, such as implementing agreed upon efficiency enhancements by a given date. FDA reports annually to Congress on progress made in achieving performance goals identified in each of the user fee commitments. These reports contain both descriptions of each center’s relevant oversight activities over the previous year, and data on its performance toward meeting user fee commitments. We found that the SIMP does not contain key elements of strategic planning and therefore does not present a comprehensive strategy across the medical product centers. Our previous work has shown that strategic planning for activities below the agency-wide level is a leading practice for successful agencies, and can help agencies integrate activities, align goals, and coordinate performance management across different parts of their organization. However, the SIMP does not fully contain several of these leading practices. Of the seven relevant strategic planning elements from GPRA, the SIMP fully contains two elements, partially contains four elements, and does not contain one element. In particular, we found that the SIMP contains a mission statement and describes how FDA incorporated input from Congress; it partially contains a description of its general goals and objectives, the strategies needed to achieve its goals and objectives, how its performance goals related to its general goals and objectives, and program evaluations used to review its goals and objectives; and it does not identify external factors that could significantly affect the achievement of its goals and objectives. Specifically, the SIMP presents high-level information on goals and performance measures for medical product oversight, but lacks detail on how it will be used or implemented. Each of the SIMP’s first two sections describes a goal—improving efficiency and developing the workforce, respectively—and lists planned or ongoing initiatives to achieve that goal. For most of these initiatives, rather than describe the necessary steps, planned accomplishments, or time frames for implementation, the SIMP provides a high-level description of what FDA expects to achieve. In addition, the SIMP’s summary states that the plan reflects coordination and cooperation among the centers to address their program-specific needs, share best practices, and share common solutions. However, FDA officials told us that they do not use the SIMP to address issues requiring center collaboration, and acknowledged that the plan did not represent the full range of working relationships among the centers. Moreover, the SIMP does not fully link its performance goals to its general goals and objectives. The SIMP instead describes performance measures related to FDA’s user fee commitments, even though several of the initiatives included in the plan are unrelated to these commitments. FDA officials explained that they focused the SIMP’s performance measures on user fee commitments rather than, for example, tying performance measures to each initiative, because user fee commitments are the main vehicle by which FDA assesses the efficiency of each medical product center’s premarket review. Additionally, groups we spoke with that represent the medical products industry did not view the SIMP as an effective strategic planning document for FDA. Of the five industry groups we interviewed, two were unfamiliar with the SIMP and the others did not see how its contents related to strategic planning. For example, representatives from one industry group said that the SIMP was neither integrated nor strategic, because it merely described the different activities of the centers rather than establishing one overarching strategic approach for all of the centers. Additionally, representatives from another industry group said that the SIMP lacked detail on how FDA would use it or implement the initiatives it described. FDA officials said that due to the circumstances around FDASIA’s enactment in 2012, they chose to develop the SIMP as a point-in-time document to address legislative requirements rather than as a strategic plan for medical product oversight. For example, agency officials said FDASIA required FDA to submit the SIMP within a year of enactment, during which time FDA was also developing its agency-wide strategic priorities document. Officials said that more time would have better enabled FDA to align the SIMP with agency-wide goals, and helped the agency to structure the plan as a strategic planning document. Officials also told us that leadership gaps in the Office of Medical Products and Tobacco, caused in part by turnover in the Deputy Commissioner position, created challenges when developing the SIMP. Officials said that, given these factors, the agency chose to develop a more limited document. Despite acknowledging that the SIMP was not intended to be an effective strategic planning document, FDA officials said that the SIMP’s development process was useful because it facilitated coordination and information sharing between the centers on how to achieve certain user fee goals. 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. Officials said that some issues, such as staffing vacancies and coordination with other agencies, were better addressed at an agency-wide level. However, they indicated that integration and collaboration across the medical product centers are important for other issues that the agency is working to address, such as data sharing, evidence generation, biomarker integration, combination products, consistent terminology, patient engagement, and the medical product review process. FDA officials also said that these types of issues have become more important as the complexity of medical products has increased, and that coordination can help the centers share leading practices to address these issues. 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. For these issues, FDA officials said that they continue to strategically plan across the centers without a written document specifically for medical products by using other planning documents. Although they noted that the agency’s resources have been better spent working toward goals in existing plans, rather than putting together a new strategic plan specific to medical product oversight, they indicated that more formal planning in the future may be useful as resources become available. 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. For example, one FDA goal is partially aimed at improving coordination within FDA, and the agency also describes some activities that may require the centers’ collaboration, such as developing comprehensive regulatory approaches for integrating approval and compliance functions. FDA officials said that they use the annual budget process as an opportunity for strategic planning. While FDA’s fiscal year 2017 budget justification describes planned activities specific to each center, its planning across the centers is limited to a few specific initiatives, such as developing scientific workshops to advance the development of pediatric therapeutic products. FDA officials identified strategic plans for specific initiatives that involve each center, such as FDA’s strategic plan for advancing regulatory science and FDA’s strategic plan for information technology. However, we recently reported on FDA’s strategic plan for information technology, finding a lack of goals and performance measures for determining whether its implementation is successful in supporting FDA’s mission. Each center also has its own strategic plan, but they differ in structure and content. While the center-specific plans include activities, goals, and objectives relevant to each individual center, they do not describe crosscutting issues or include plans for collaboration across the centers to address them. Officials from each center said that they also relied on performance measures in other documents, such as user fee commitments, to plan their activities and measure their performance. The growing importance of areas that cut across medical product centers highlights the importance of FDA’s strategic planning for medical product oversight. 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. These practices indicate that formal strategic planning is needed for medical products by identifying crosscutting issues and ensuring that collaborative center goals, measures, and activities are effectively integrated with FDA’s overall organizational mission and goals. 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. In FDA’s SIMP, the agency compiled 30 efficiency initiatives under three different themes and included 19 different types of workforce development initiatives for each center on training, recruitment, and retention. 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. We found that FDA grouped the SIMP’s 30 efficiency initiatives into three themes: (1) business modernization, (2) process improvement, and (3) smarter regulation. (See appendix I for a full description of each efficiency initiative.) Under business modernization, FDA included 3 initiatives on each center’s workload measurement activities, 3 initiatives focused on data standards efforts, and 2 initiatives specific to staff location and ability to use electronic functions to complete their work. For the initiatives on the centers’ workload measurement activities, the centers each updated their time reporting systems to record user fee activities, which employees are required to do in 2-week increments four times during the fiscal year. Under process improvement, FDA included 11 efficiency initiatives specific to an agency-wide or center-specific need. CBER included initiatives to improve its review mechanisms and move to more electronic processes. CDER included efforts to streamline processes for its formal communication mechanisms with the industry and manufacturing facilities. CDRH included pilot programs for certain device types and manufacturers, and a postmarket program for identifying new device risks. Under smarter regulation, FDA included 11 initiatives—8 initiatives that stem from each user fee program, as well as 3 initiatives for medical devices that respond to other statutory requirements. The majority of the 11 initiatives are focused on the premarket review process of medical products. Specifically, the initiatives are related to improving communication between FDA and the industry, providing additional guidance to industry for how FDA will assess medical products, providing its plans for health information technology, and defining FDA’s approach to and requirements for facilities that manufacture drug products. The SIMP notes that these three themes reflect the strategic goals and priorities that the medical product centers are all pursuing to improve efficiency. FDA officials further explained that the three themes helped to connect seemingly unrelated center-specific and user fee program responsibilities and initiatives presented in the SIMP. 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. For example, CDRH specified that its initiative to establish a unique device identification system started with the highest risk medical devices and will be fully implemented in 2020 once all medical devices have identifiers in electronic health records. (See table 1.) We found that FDA included 19 workforce development initiatives in the SIMP—11 training initiatives, 7 recruitment initiatives, and 1 retention initiative. (See appendix II for a full description of each workforce development initiative.) FDA officials told us that the majority of the workforce development initiatives are specific to each center’s activities, reflecting differences in program responsibilities and procedures. Industry officials we spoke with emphasized the importance of recruitment, retention, and training efforts on the agency’s ability to meet user fee commitments. (For more information on the size and characteristics of FDA’s overall and center-specific workforce, see appendix III.) The 11 training initiatives FDA included in the SIMP describe multiple training courses or programs. As part of these initiatives, FDA included programs for the new reviewer trainings offered by each of the medical product centers and initiatives covering training for each of the user fee programs, which may be taken by staff from multiple centers. The initiatives also included training courses dedicated to specific topics for each medical product center. For example, CBER included training courses covering medical device review and project management, and CDRH included two leadership experience programs for future and current managers. The first CDRH program gives certain staff an opportunity to explore a supervisory career path; the second is to help staff in management positions learn about CDRH’s management competencies and satisfy federal supervisory training requirements. We found that the seven recruitment initiatives FDA included in the SIMP are intended to streamline recruitment processes at both the agency and center levels. For example, CDER included initiatives to manage and fill vacancies in executive-level positions and critical occupations, such as chemists and project managers. Each of the centers also included initiatives to improve outreach to potential job candidates, such as through job fairs, alumni networks, and institutional partnerships. For retention, we found that FDA included a single initiative in the SIMP— CDRH’s efforts to address the center’s high attrition rate by reducing individual workloads, decreasing staff-to-manager ratios, and providing employees with a better work environment. To reduce staff workloads and decrease staff-to-manager ratios, CDRH increased the number of review and management staff. To provide a better work environment, CDRH developed and improved performance evaluation tools and employee recognition processes. For example, CDRH created a resource guide to educate staff on the center’s performance management system. FDA did not include retention initiatives for CBER or CDER in the SIMP; however, officials from both centers told us that each center uses some retention tools and processes. Among the 19 workforce development initiatives included in the SIMP, 15 initiatives were implemented prior to the plan’s issuance in July 2013. By March 2016, FDA implemented 2 additional workforce development initiatives, bringing the total to 17 initiatives. Of the remaining 2 initiatives, 1 is still being implemented. CDRH is in the process of reducing staff workloads as part of the center’s retention initiative—an activity related to hiring plans that are to be phased in through fiscal year 2017. The final one, CDER’s alumni network initiative, was terminated. CDER planned to pilot the initiative in four of its offices beginning in 2013, but it was never piloted or implemented due to a lack of employee activity in alumni associations. (See table 2.) We found that FDA had already established or has plans to establish formal and informal mechanisms to assess the effectiveness of just over half of the 30 efficiency initiatives in the SIMP. 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 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. In its plan, FDA identified formal measures of effectiveness for 3 initiatives, each of which is based on a MDUFA or PDUFA commitment, but does not specify any additional measures in the plan itself for the remaining 27 initiatives. (See table 3.) However, we found that FDA has formal or informal measures that do not appear in the SIMP for a majority of these initiatives. 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. For example CDER officials told us that the GDUFA initiative on commitments, complete review, and easily correctable deficiencies is assessed against the user fee commitments. For example, FDA committed to review and act on 90 percent of complete, electronic abbreviated new drug applications within 10 months after the date of submission. FDA does not have to meet some of these commitments until 2017, but the agency indicated that it faces challenges meeting them due to a large backlog of applications. CDRH officials told us that they assessed the investigational device exemption decision program using center-specific strategic goals related to reducing the number of review cycles needed before full approval, and reducing the overall median time to full approval. CDRH met each of these goals in fiscal year 2015. For nine initiatives, officials from each center described efforts they took to informally examine effectiveness. For example, CBER uses staff feedback to assess implementation of its electronic review templates, and incorporates revisions as appropriate. For CDRH’s initiative to establish a unique device identification system, officials said they track certain metrics, such as numbers of vendors certified to participate in the program and visits to the program’s website. 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. In some cases, officials described ways in which effectiveness could be measured or efforts to develop assessments. For example, CDRH officials told us that they did not currently have, but were exploring, ways to measure the impact of its signal management program initiative through industry responses or actions taken. In other instances, such as with CBER’s two initiatives on improving its managed review process tool, officials indicated that they were unclear about the best way to measure effectiveness. Additionally, FDA does not have current plans to measure effectiveness of some initiatives and officials noted that such measurement would be either unnecessary or impractical. For example, FDA is not measuring effectiveness for the PDUFA meeting minutes initiative, because officials said it would be a challenge to survey sponsors and the agency wants to be selective about choosing that option. FDA identified mechanisms to assess the effectiveness of 12 of the 19 workforce development initiatives. Specifically, the agency identified mechanisms to assess 4 of 7 recruitment initiatives, the 1 retention initiative, and 7 of 11 training initiatives. In the SIMP, FDA generally did not describe assessments for specific initiatives, but rather described each user fee program’s hiring and training commitments as broad measures of the agency’s workforce development efforts. For example, in order to reach the committed GDUFA level of 923 full-time equivalent staff by the end of fiscal year 2015, FDA committed to hire and then train at least 25 percent of staff in fiscal year 2013 and 50 percent in fiscal year 2014. FDA reported that it met this commitment by October 2014, 11 months ahead of schedule. (As previously noted, appendix III provides additional information on the size and characteristics of FDA’s overall and center-specific workforce.) FDA officials described the mechanisms in place to assess the effectiveness of 4 of the 7 recruitment initiatives described in the SIMP. For the two that are FDA-wide recruitment initiatives, FDA uses agency- and department-wide tools to measure the overall effectiveness. Specifically, FDA developed the FDA Accelerated Staffing Track 80-day hiring metric in early fiscal year 2015 to measure the time it takes to hire a new employee once the need is identified. However, officials said that data quality and data entry issues limited the accuracy and validity of the data available at the time of our review. In addition, FDA uses HHS personnel information systems to track monthly and quarterly hire and separation data for each medical product center. Officials also described performance metrics that CBER and CDRH track to assess effectiveness for two center-specific recruitment initiatives. For CBER’s comprehensive recruitment strategy, the center tracks the number of resumes received and hires from targeted populations. For example, CBER hired four veteran; five minority; and 31 science, technology, engineering, and mathematics candidates during fiscal year 2015. For CDRH’s initiative on strategic communication and outreach for recruitment, the center uses monthly reports to track the number of applicants responding to the center’s job postings, including data on the number of applicants that apply to and are eligible for each position. For the three recruitment initiatives that do not currently have mechanisms to assess effectiveness, CDER officials described the center’s current plans or what it had already done. For one initiative, officials said that the center is developing an automated project management and tracking tool. Officials expect that the tool will be implemented in spring 2016. For another initiative, CDER met its overall hiring objectives, but did not measure the number of selections made as a result of the initiative itself. Finally, CDER’s alumni network initiative was never implemented, and thus FDA did not put in a place a mechanism to assess its effectiveness. To assess the effectiveness of the one retention initiative in the SIMP, CDRH officials told us they measure the number of full-time equivalent staff supporting MDUFA activities, changes in staff-to-manager ratios, and survey results. CDRH’s total full-time equivalent staff supporting MDUFA increased from 1,133 in fiscal year 2013 to 1,293 in fiscal year 2015. At the same time, CDRH reduced the staff-to-manager ratio in its two offices with medical device review responsibilities. CDRH also analyzes changes in federal Employee Viewpoint Survey responses to assess its efforts to provide a better workplace for its employees. From 2011 to 2014, CDRH observed positive changes for three of six critical indicators it identified for providing recognition and all six critical indicators it identified for performance evaluation. Of the 11 training initiatives, CBER, CDER, and CDRH officials each identified mechanisms to assess the effectiveness of 7 initiatives. Specifically, each center indicated that it uses participant surveys to assess effectiveness. CBER also delivers a test at the conclusion of some, but not all, of the programs included in its training initiative.Furthermore, as described in the SIMP, CDRH conducts an audit process for its Reviewer Certification Program through which new reviewers are evaluated by an experienced reviewer. During the audit process, new reviewers are rated against six criteria, including the appropriate use of guidance and strength of final review decision analyses. The four remaining training initiatives described in the SIMP were related to each user fee program and the centers use different approaches to assess the extent to which all reviewers required to complete training have done so. CBER and CDER track the names of staff who register for training and do not measure the number of medical product reviewers required to complete the trainings. CBER and CDER officials said that FDA was not required to report on training completion rates, and they assume that required staff completed user fee training, because it is made available in different settings, such as CBER’s review management updates and CDER’s new employee orientation. For example, CDER officials told us that 99 percent of the staff hired under the GDUFA commitment had completed training, as all hired staff take mandatory online training once hired. Training completion rates are not included in GDUFA performance reports. In contrast, CDRH measures user fee training completion rates among its required staff and reports on these rates in MDUFA quarterly performance reports, as required by their user fee commitments. CDRH reported a 99 percent staff completion rate among its review staff required to complete MDUFA training. Center officials did not identify any mechanisms to assess how effective participants were in applying the information learned during these user fee trainings (known as training comprehension). CBER officials said its user fee trainings were delivered and recorded in special training sessions, such as in monthly review management updates, and that these trainings do not have mechanisms to assess comprehension. CDER officials were unable to show that staff who took user fee trainings were given post-completion tests. CDRH officials told us that a post- completion test was not disseminated for the initial MDUFA trainings. However, CDRH has since incorporated the user fee trainings into the center’s Reviewer Certification Program, which has multiple mechanisms for assessment. Emerging issues—including increasingly complex medical products such as combination products, the need for integrated information systems, and the increased hiring demands for specific scientific knowledge—go beyond the expertise of a single medical product center and highlight the growing importance of strategic planning across medical products. Advances involving new diagnostic tools, treatments, and cures require collaboration in order to be successful. However, FDA has faced longstanding challenges in carrying out the many responsibilities necessary for the oversight of medical products. While FDA engaged each of the medical product centers in the development of the SIMP, this narrowly focused plan is not used by the agency or centers. Moreover, it highlights gaps in the agency’s management across FDA’s medical product centers by not fully linking its performance goals to its general goals and objectives, and having limited information on implementation time frames. While FDA has various other strategic planning documents for medical product oversight, these documents also do not set a long- term strategy for the centers, because they are focused on narrower issues or do not have details specific to center-level collaboration. Using leading practices identified as essential for strategic planning can help ensure the agency is prepared to address challenges requiring coordination across the centers in a consistent and transparent manner. Documenting measurable goals, objectives, and a long-term strategy for areas resulting from this planning—whether it is through a freestanding document or as part of existing documents—can help the agency ensure its priorities are communicated among key stakeholders, even in times of leadership turnover. 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. We provided a draft of this report to HHS. The agency agreed with our recommendation and provided written comments, which are reprinted in appendix IV. In its written comments, HHS described the context surrounding the development of the SIMP and the progress FDA has made regarding its medical product review activities under its four user fee programs. It noted the importance of coordinating and integrating the activities that are common among FDA’s medical product centers. In agreeing with our recommendation, HHS indicated that FDA has already started a process to identify key crosscutting themes for the medical products centers, which it will then use to develop an overarching strategic planning framework to guide the work of these centers. We encourage FDA to use leading practices to ensure this framework has measurable goals and objectives. As agreed with your offices, unless you publicly announce the contents of this report earlier, we plan no further distribution of it until 30 days from its date. At that time, we will send copies to the Secretary of Health and Human Services. In addition, the report will be available at no charge on the GAO website at http://www.gao.gov. If you or your staffs have any questions about this report, please contact me at (202) 512-7114 or crossem@gao.gov. Contact points for our Offices of Congressional Relations and Public Affairs may be found on the last page of this report. GAO staff who made key contributions to this report are listed in appendix V. Table 4 shows each efficiency initiative that the Food and Drug Administration (FDA) included in its strategic integrated management plan. FDA described 30 efficiency initiatives in its plan, including those specific to a medical product center or to a user fee program. FDA also grouped the initiatives into three themes: (1) business modernization, (2) process improvement, and (3) smarter regulation. Table 5 shows each workforce development initiative the Food and Drug Administration (FDA) included in its strategic integrated management plan. FDA described 19 workforce development initiatives in its plan specific to recruitment, retention, or training. We analyzed Food and Drug Administration (FDA) data on the agency’s workforce population and attrition for fiscal years 2012 to 2015. Our analysis includes detail on the three medical product centers: the Center for Biologics Evaluation and Research (CBER), the Center for Drug Evaluation and Research (CDER), and the Center for Devices and Radiological Health (CDRH). FDA’s total workforce grew from 16,716 employees in 2012 to 19,043 employees in 2015—a 14 percent increase. FDA measures year-to-year changes in its total workforce by subtracting the employee losses from the employee gains of permanent and non- permanent staff. Figure 2 shows the number of medical product center employees—permanent and non-permanent—for each fiscal year. Some losses and gains reported by the centers are due to employees that transferred within the agency, such as from one center to another. Tables 6, 7, and 8 show information on transfers within FDA for each medical product center in fiscal years 2012 to 2015. FDA also tracks the percentage of retirement-eligible staff. In fiscal year 2015, 12.4 percent of FDA’s overall permanent workforce was retirement- eligible. In the same fiscal year, the retirement eligibility for each medical product center was 15.9 percent for CBER, 10.9 percent for CDER, and 11.8 percent for CDRH. Figure 3 shows the FDA-wide and center-specific attrition rates from fiscal year 2012 to 2015. FDA calculates attrition rates by dividing the number of voluntary personnel losses by the average number of employees for each fiscal year. Voluntary personnel losses include retirements, resignations, and employees who transfer externally to another federal agency or internally to a different center or office within FDA. The following tables show the number of employees, personnel gains, and attrition rates for FDA and each medical product center. The tables also include information on mission-critical occupations, which may vary by center. In addition to the contact named above, William Hadley, Assistant Director; George Bogart; Jennel Lockley; Drew Long; Matt Lowney; Dan Powers; and E. Jane Whipple made key contributions to this report.

Summary: 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. 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. 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.