Recommendation: To improve operational efficiencies and reduce costs related to product management and services that support commissary operations, the Secretary of Defense should direct the Chief Executive Officer of DeCA to conduct comprehensive cost-benefit analyses to guide decisions on implementing the most cost-effective option as stocking and custodial services contracts are renewed, and on choosing product distribution options.

Agency: Department of Defense
Status: Open

Comments: The Defense Commissary Agency (DeCA) agreed with GAO's March 2017 recommendation that it conduct comprehensive cost-benefit analyses to guide decisions on implementing the most cost-effective option as stocking and custodial services contracts are renewed, and on choosing product distribution options. For example, according to Department of Defense (DOD) officials, DeCA conducted a cost-benefit analysis as part of renewing an agreement with one of the Navy Exchanges in May 2018 and will provide service on a reimbursable basis instead of using the commercial vendor. DeCA officials stated that they will also review product distribution options during commercial negotiations, including taking into account product sales and shipment requirements, among other things. As of January 2020, DOD has not provided documentation to confirm completed actions to implement our recommendations. When we confirm what actions DOD has taken, we will provide updated information.

Recommendation: In order for drug sponsors to benefit from FDA's revised guidance on antibiotic development and take full advantage of the QIDP designation, FDA should develop and make available written guidance on the QIDP designation that includes information about the process a drug sponsor must undertake to request the fast track designation and how the agency is applying the market exclusivity incentive.

Agency: Department of Health and Human Services: Food and Drug Administration
Status: Open

Comments: According to HHS, FDA issued draft guidance (a document of frequently asked questions) in January of 2018 that describes the QIDP designation. However, this document is in draft form and has not yet been finalized. As of August 2020, FDA reported it is working to finalize this guidance this year. GAO will revisit this recommendation when the final guidance is issued.

Recommendation: 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.

Agency: Department of Health and Human Services
Status: Open

Comments: 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. However, FDA still needs to document steps taken by these centers to develop measurable goals, and the agency indicated that the recommendation should remain open. GAO will continue to monitor the implementation of this recommendation.

Recommendation: 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.

Agency: Department of Health and Human Services
Status: Open

Comments: In September 2018 and July 2019, the agency described actions taken by each center to better track its regulatory science funding. However, FDA still needed to complete these activities and document that funds are systematically tracked across each of the priority areas. In an August 2020 written response, the agency reported that there continue to be efforts to improve tracking of funds for regulatory science projects in priority areas. Specifically, it described the development 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. According to FDA, as part of the internal accountability framework, it will track regulatory science projects. FDA reported that its goal was to complete this work by the end of December 2020. The agency indicated that the recommendation should remain open, and GAO will continue to monitor the implementation of this recommendation.

Recommendation: To provide greater compliance with the GIDEP reporting requirement among the DOD components and their defense supplier-base, the Undersecretary of Defense for Acquisition, Technology and Logistics should establish mechanisms for department-wide oversight of defense agencies' compliance with the GIDEP reporting requirement.

Agency: Department of Defense: Office of the Secretary of Defense: Office of the Under Secretary of Defense for Acquisition, Technology, and Logistics
Status: Open

Comments: In providing comments to this report DOD concurred with this recommendation but has not completed actions to implement it. DOD has drafted new combined DOD instruction and guidance that addresses the process of reporting suspected counterfeit parts to GIDEP. As of August 2020, the document is still in the process of being formally approved. DOD estimated that it could be approved in the first quarter of fiscal year 2021.

Recommendation: To provide greater compliance with the GIDEP reporting requirement among the DOD components and their defense supplier-base, the Undersecretary of Defense for Acquisition, Technology and Logistics should develop a standardized process for determining the level of evidence needed to report a part as suspect counterfeit in GIDEP, such as a tiered reporting structure in GIDEP that provides an indication of where the suspect part is in the process of being assessed.

Agency: Department of Defense: Office of the Secretary of Defense: Office of the Under Secretary of Defense for Acquisition, Technology, and Logistics
Status: Open

Comments: In providing comments to this report DOD concurred with this recommendation but has not completed actions to implement it. DOD has drafted new combined DOD instruction and guidance that addresses the process of reporting suspected counterfeit parts to GIDEP. As of August 2020, the document is still in the process of being formally approved. DOD estimated that it could be approved in the first quarter of fiscal year 2021.

Recommendation: To provide greater compliance with the GIDEP reporting requirement among the DOD components and their defense supplier-base, the Undersecretary of Defense for Acquisition, Technology and Logistics should develop guidance for when access to GIDEP reports should be limited to only government users or made available to industry.

Agency: Department of Defense: Office of the Secretary of Defense: Office of the Under Secretary of Defense for Acquisition, Technology, and Logistics
Status: Open

Comments: In providing comments to this report DOD concurred with this recommendation but has not completed actions to implement it. DOD has drafted new combined DOD instruction and guidance that addresses the process of reporting suspected counterfeit parts to GIDEP. As of August 2020, the document is still in the process of being formally approved. DOD estimated that it could be approved in the first quarter of fiscal year 2021.

Recommendation: To help ensure that FDA's IT strategic planning activities are successful in supporting the agency's mission, goals, and objectives, the Commissioner of FDA should require the CIO to implement the plan to ensure that expected outcomes of the agency's key IT initiatives are achieved.

Agency: Department of Health and Human Services: Food and Drug Administration
Status: Open

Comments: According to agency officials, FDA's CIO met with the FDA Commissioner in 2016 where the updated IT strategic plan was reviewed and approved. The Commissioner identified key IT initiatives to be implemented within FY2017 and incorporated them into the CIO's performance management appraisal program. According to officials, the Commissioner requires the CIO to implement a plan to ensure that expected outcomes of the agency's key IT initiatives are achieved. Although FDA provided us with an excel spreadsheet that identifies IT initiatives at the agency's weekly FDA project meeting, we requested additional documentation regarding the plan the CIO is required to implement to ensure that expected outcomes of the agency's key IT initiatives are fulfilled. We contacted FDA in September and December 2019 and January 2020 to obtain additional information on the actions taken to implement the recommendation, but have not received a response. We will update the recommendation when additional information is obtained.

Recommendation: To improve the data on tracked safety issues and postmarket studies that are needed for required reporting and for systematic oversight of postmarket drug safety, the Secretary of HHS should direct the Commissioner of FDA to work with stakeholders within FDA to identify additional improvements that could be made to FDA's current database or future information technology investments to capture information in a form that can be easily and systematically used by staff for oversight purposes.

Agency: Department of Health and Human Services
Status: Open

Comments: FDA has made changes intended to improve its process for overseeing tracked safety issues, but as of August 2020, FDA was still working on changes to its process for postmarket study data. For tracked safety issues, FDA held a one-day workshop to solicit input from staff on changes to its tracked safety issue process and collect user requirements for a new IT system to support tracking safety issues. In April 2020, FDA finalized new policies and procedures and implemented a new IT system for tracking safety issues. The new IT system allows anyone within FDA's Center for Drug Evaluation and Research to enter new safety signals and has integrated product and adverse event dictionaries. FDA stated that integrating standardized data will support consistent regulatory decisions and improve the quality of analysis. For postmarket studies, FDA has indicated that it intends to formally assess the IT needs of users as part of the planned transfer of postmarket data to its new informatics platform. As of August 2020, FDA anticipated creating a project team to address specific concerns related to postmarket study data by the end of calendar year 2020 or the beginning of calendar year 2021. GAO is keeping this recommendation open until FDA has completed its planned improvements to its process for tracking postmarket study data.

Recommendation: To improve CTP's ability to operate efficiently, achieve effective results, and plan appropriately, the Secretary of Health and Human Services should direct the Commissioner of FDA to monitor FDA's performance relative to those time frames, such as evaluating whether staff are performing reviews of these submissions efficiently and effectively.

Agency: Department of Health and Human Services
Status: Open

Comments: FDA has established and monitored performance measures that include time frames for reviewing and acting on regular SE submissions, Exemption from SE requests, and Modified Risk Tobacco Product applications for fiscal years 2015 through 2018. However, we are leaving this recommendation open until FDA begins monitoring its performance relative to timeframes for provisional SE submissions, which the agency plans to do at the end of fiscal year 2019.

Recommendation: To improve the awareness, use, and usefulness of SaferProducts.gov, the CPSC should implement cost-effective usability improvements to SaferProducts.gov, taking into account the results of any existing usability testing or any new testing CPSC may choose to conduct.

Agency: Consumer Product Safety Commission
Status: Open

Comments: The Commission has taken some steps to address this recommendation by making usability improvements to SaferProducts.gov that we identified in our consumer testing in our report. For example, in 2015, the Commission addressed issues identified with the search functionality of the website by improving the advanced search function to enable searches by injury, time period, and location. In August 2018, the Commission clarified the purpose of SaferProducts.gov by adding the tagline (brief text that gives users an immediate idea of what the site does) "Report. Search. Protect." to its website. As of August 2019, CPSC has explored further ways to improve the usability of SaferProducts.gov. Specifically, in February 2019, CPSC published a request for information from the public on how to improve SaferProducts.gov. In March 2019, CPSC held a public hearing to obtain a feedback on how the design of SaferProducts.gov and process of submitting safety reports could be improved. For example, two consumer groups recommended that CPSC further improve the website's search function to yield more relevant and streamlined results and that it be designed for better use on mobile devices. Based on this input, CPSC is in the process of developing a plan for re-designing SaferProducts.gov using modern web-design standards, which includes improving the website's layout and styling, search capabilities, and functionality on mobile devices. According to CPSC, its staff plans to explore cost-effective resources to assess usability and identify further improvements to the website, such as coordinating with the General Services Administration on the design aspects of SaferProducts.gov and using other federal best practices to inform this process. However, no such cost-effective changes have yet been made to the website. According to officials, CPSC plans to begin this re-design in 2019 or 2020 pending available future funding. Until the Commission fully addresses this recommendation, it remains open. We will continue to monitor the Commission's progress in implementing our recommendation.