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Medical Product Oversight: FDA Needs More Strategic Planning to Guide Its Scientific Initiatives

GAO-16-432 Published: May 16, 2016. Publicly Released: Jun 15, 2016.
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What GAO Found

The Food and Drug Administration (FDA) lacks measurable goals to assess its progress in advancing regulatory science—the science supporting its effort to assess the products it regulates. The agency issued strategic planning documents in 2011 and 2013 to guide its regulatory science efforts and identify priority areas for conducting work, but these documents do not specify the targets and time frames necessary for the agency to measure progress overall or within each of the eight priority areas related to medical products. According to leading practices for strategic planning, identifying and using consistent measurable goals in planning and progress documents is important to assessing effectiveness. While FDA cited examples of its achievements in regulatory science in a 2015 report, FDA cannot assess how those achievements constitute progress towards its goals. In addition, FDA lacks information about how funding targeted at regulatory science is distributed across the priority areas. Decisions to award these funds are made by individual FDA centers and offices, which generally did not collect information on the associated priority areas of funded projects. Rather, FDA retrospectively identified these areas for the purpose of GAO's review. The lack of consistent information limits FDA's ability to examine obligations across, or progress within, specific priority areas. 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.

FDA obligations for regulatory science projects generally increased from fiscal years 2010 through 2014 and totaled more than $507 million across that period. Nine centers and offices obligated funds, with totals for each center or office ranging from approximately $450,000 to about $200 million. The Office of the Chief Scientist (in particular, the National Center for Toxicological Research) funded 65 percent of the total obligations. FDA obligated funds towards each of the regulatory science priority areas, ranging from about $3 million for global product safety to approximately $203 million for toxicology . The clinical evaluations and personalized medicine and medical countermeasures priority areas were also among those with the greatest obligations.

For the 17 regulatory science projects GAO reviewed, FDA identified achievements ranging from the dissemination of project findings to changes in both agency and external stakeholder practices. For example, FDA reported that all projects resulted in some type of change within FDA. About half of the projects resulted in the agency developing standards, methods, tools, or training that it could use internally, and about one-third of the projects affected guidance or regulations. FDA also reported that about half of the projects resulted in the development of new tools or standards for use by industry or other stakeholders, in areas such as setting new standards for defibrillators to account for radio interference.

Why GAO Did This Study

FDA has faced challenges regulating medical products, owing in part to rapid changes in science and technology. In 2010, FDA established a regulatory science initiative that identified eight priority areas for medical products where new research was needed to advance its mission. Legislation enacted in 2012 required FDA to establish a plan for measuring its progress on its regulatory science efforts.

GAO was asked to examine FDA's progress on its regulatory science efforts related to medical products. In this report, GAO (1) evaluates FDA's strategic planning efforts to address its regulatory science priorities, (2) describes FDA's funding targeted at regulatory science projects, and (3) describes the achievements of selected FDA regulatory science projects. GAO compared related FDA strategic planning documents to federal internal control standards and leading practices for strategic planning. GAO reviewed FDA data on obligations targeted at regulatory science projects for fiscal years 2010 through 2014 and reviewed the achievements FDA reported from a sample of 17 projects, chosen to ensure nine FDA centers and offices and priority areas are represented.

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To improve strategic planning for regulatory science efforts, FDA should (1) develop and document measurable goals, including targets and time frames, and (2) systematically track funding across its regulatory science priority areas. The Department of Health and Human Services agreed with GAO's recommendations.

Recommendations for Executive Action

Agency Affected Recommendation Status
Department of Health and Human Services In order to improve FDA's strategic planning for regulatory science efforts, the Secretary of Health and Human Services should direct the Commissioner of FDA to develop and document measurable goals, such as targets and time frames, for its regulatory science efforts so it can consistently assess and report on the agency's progress in regulatory science efforts.
In September 2018, the agency described the actions of committees developed by each of the centers to oversee their regulatory science activities. In July 2019, the agency indicated that it was revisiting its strategic regulatory science priorities as part of its cyclical strategic planning process, and the centers and various offices have taken steps to address the recommendation. In an August 2020 written response, the agency reported that a committee had undertaken a review its 2011 regulatory science strategic plan that will result in the issuance of an accountability framework--an internal document outlining the type of information that FDA centers and offices will provide to the agency's Chief Scientist to demonstrate progress made in addressing relevant focus areas of regulatory science. FDA reported that its goal was to complete this work by the end of December 2020. In a June 2021 written response, FDA indicated it had issued a report and identified steps toward gathering relevant information to demonstrate progress for regulatory science efforts. As part of this, it noted that several working groups are identifying outcomes of value for each center, office, and across the agency, and that could be aggregated at some level in the focus areas of regulatory science as well as the broader portfolio of research within each center. In June 2022, FDA described some of its reporting and tracking efforts. However, FDA still needs to document steps taken to develop measurable goals, and the agency indicated that the recommendation should remain open. GAO will continue to monitor the implementation of this recommendation.
Department of Health and Human Services In order to improve FDA's strategic planning for regulatory science efforts, the Secretary of Health and Human Services should direct the Commissioner of FDA to systematically track funding of regulatory science projects across each of its priority areas.
Closed – Implemented
FDA implemented a process to systematically track funding of its regulatory science projects. In June 2021, FDA indicated that it had made significant strides toward tracking funding for its regulatory science projects. In August 2021, it provided documentation of the information it is tracking for its regulatory science projects, including the project's relevant regulatory science priority area.

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