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.