Two recent Government Accountability Office (GAO) reports concluded that (1) the FDA lacks measureable goals to assess its progress in advancing the regulatory science that supports the medical products it oversees, and (2) the FDA’s 2013 strategic integrated management plan (SIMP) for its three centers (drugs, biologics, and medical devices) does not incorporate leading practices for strategic planning or document a comprehensive strategy for the centers.
Regulatory science efforts
The FDA Safety and Innovation Act of 2012 (FDASIA) (P.L. 112-144) required the FDA to establish a plan for measuring its progress in its regulatory science efforts. As a result, the FDA issued strategic planning documents in 2011 and 2013 to guide its regulatory science efforts and identify priority areas for conducting work. However, according to the GAO (Report No. GAO-16-432), these documents do not specify the targets and time frames necessary for the FDA to measure progress overall or within each of the priority areas related to medical products. In addition, while the FDA cited examples of its achievements in regulatory science in a 2015 report, the GAO found that the FDA is unable to assess how those achievements constitute progress towards its goals. In addition, the FDA lacks information about how funding targeted at regulatory science is distributed across the priority areas.
According to the GAO, standards for internal control in the federal government state that complete and accurate data are needed to make operating decisions and allocate resources. Furthermore, multiple centers or offices fund projects toward a given priority area and leading practices for strategic planning encourage agencies to manage efforts that cut across the agency. The GAO concluded that the lack of consistent information limits the FDA’s ability to examine obligations across, or progress within, specific priority areas.
To improve its strategic planning for regulatory science efforts, the GAO recommended that the FDA: (1) develop and document measurable goals, including targets and time frames: and (2) systematically track funding across its regulatory science priority areas.
The HHS agreed with the importance of strategic planning for regulatory science. It concurred with the GAO recommendation that the FDA should develop and document measureable goals. HHS suggested, however, that the FDA documents with a targeted focus, such as user fee commitment letters and specific planning documents, are a more appropriate place for such goals than an agency-level strategic plan. HHS also concurred with the GAO’s recommendation to systematically track funding across the FDA’s regulatory science priority areas. In its response, HHS also identified recent and planned activities of specific centers to improve such tracking.
Coordination between centers
In 2012, the FDASIA required the FDA to develop a SIMP for the three centers overseeing medical products. The SIMP was to identify initiatives for improving efficiency, initiatives for workforce development, and measures for assessing the progress of these initiatives. FDA issued the SIMP in July 2013.
In the SIMP, the FDA compiled mostly preexisting initiatives to improve the efficiency of each center’s activities and develop its workforce. The GAO found (Report No. GAO-16-500) that the SIMP did not incorporate leading practices for strategic planning or document a comprehensive strategy for the centers. In response, the FDA officials explained that circumstances at the time of the SIMP’s development, including leadership gaps, limited its ability to structure the plan into an effective strategic planning document. The FDA officials told the GAO that they use a variety of other key documents for strategic planning—such as agency-level and initiative-specific plans. According to the GAO, however, these other plans do not describe a long-term strategy for addressing key issues that cut across medical product centers. The FDA officials acknowledged to the GAO that there is a growing need for strategic planning across the medical product centers to improve center collaboration and address emerging issues.
The GAO found that an absence of a comprehensive long-term plan for medical product oversight could hinder the FDA’s efforts to address emerging issues that require center collaboration, such as access to quality data. The GAO concluded that fully documenting such a strategy, either in a separate plan or through existing documents, would help the FDA identify measurable goals and objectives for their centers that align with its mission and help communicate its priorities to key stakeholders.
The GAO recommended that the FDA 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. The HHS agreed with the recommendation. It indicated that the FDA has already started a process to identify key crosscutting themes for the medical products centers, which it will use to develop an overarching strategic planning framework to guide the work of these centers.