Three FDA regulatory centers help ensure the safety, security, and effectiveness of medical products. These centers had $200 million in property-related expenses in FY 2019.
We found that the centers did not consistently collect, analyze, and verify the accuracy of information needed to manage personal property, such as scientific and laboratory equipment and office furniture. Effective management of property can help ensure sound decision-making and minimize resource waste.
We made 4 recommendations, including that the FDA establish formal policies to use quality information to manage the personal property used by these centers.
Food and Drug Administration Laboratory Equipment
What GAO Found
From fiscal years 2012 through 2019, the Food and Drug Administration (FDA) obligated a combined total of $14.7 billion to support operations at the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, and the Center for Devices and Radiological Health. During this period, 56 percent of the three centers' total obligations came from user fees, which FDA negotiates with and collects from regulated industries (e.g., manufacturers). The other 44 percent of the centers' total obligations came from regular appropriations. On average, property-related expenses represented 12 percent of the centers' total annual obligations; approximately half of property-related expenses were for rent.
Obligations for Three of the Food and Drug Administration's Regulatory Centers by Budget Authority Type, Fiscal Years 2012 through 2019
In managing their personal property (e.g., scientific equipment, computers, and office furniture), these centers did not consistently use quality information related to three phases of asset management:
(1) planning for property needs;
(2) operating and maintaining property; and
(3) reviewing property performance.
For example, officials at all three centers described informal, disparate processes for collecting and using information to identify and prioritize personal property needs. Furthermore, center staff conducted these activities differently, potentially resulting in inconsistent asset data. Using quality information—which involves consistently collecting, analyzing, and verifying the accuracy of data—can help agencies effectively manage assets such as personal property. It is a key characteristic integral to effective asset management, criteria GAO developed in prior work based on federal guidance and international standards. By establishing and implementing formal policies for using quality personal property information, FDA and the three centers can more effectively manage their personal property's useful life, plan for and respond to potential changes to the centers' funding and priorities, and maximize the value of the centers' personal property.
Why GAO Did This Study
Three FDA regulatory centers have primary responsibility for ensuring human medical products' safety, security, and effectiveness. FDA uses personal property and real property (e.g., buildings) to help achieve this oversight mission.
Congress included a provision in statute for GAO to examine FDA's expenses related to property at the three centers and evaluate FDA's ability to further its mission through management of those assets. Among other things, this report: (1) identifies the funds FDA obligated for these centers, and (2) assesses FDA's use of quality information to manage the centers' personal property. GAO reviewed financial data and interviewed officials about FDA's obligations from fiscal years 2012 through 2019. In addition, GAO compared criteria related to using quality information to FDA's relevant policies and processes, and interviewed FDA and General Services Administration (GSA) officials about FDA's property management.
GAO is making four recommendations to FDA and GSA, including that FDA establish and implement formal policies to use quality information to plan for, operate and maintain, and review performance of personal property used by the three centers. The agencies agreed with the recommendations.
Recommendations for Executive Action
|Food and Drug Administration||1. The Commissioner of FDA should establish and implement formal policies to use quality information (e.g., linking decisions to mission-related goals) in the three centers' planning for their personal property needs, consistent with key characteristics integral to asset management leading practices. (Recommendation 1)|
|Food and Drug Administration||2. The Commissioner of FDA should establish and implement formal policies to use quality information (e.g., tracking condition, and maintenance and repair costs) in the three centers' operations and maintenance of personal property, consistent with key characteristics integral to asset management leading practices. (Recommendation 2)|
|Food and Drug Administration||3. The Commissioner of FDA should establish and implement formal policies to use quality information (e.g., measuring and documenting performance) in the three centers' reviews of personal property performance, consistent with key characteristics integral to asset management leading practices. (Recommendation 3)|
|General Services Administration||4. The Administrator of GSA should take steps to ensure that the condition of all White Oak facilities that FDA occupies are assessed, including limited access areas and tenant improvements that are above the standard services and facilities that GSA provides. (Recommendation 4)|