Recommendation: 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)

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

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: 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)

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

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: 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)

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

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Commissioner of the FDA should ensure that PAC renews its charter. (Recommendation 1)

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

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Commissioner of FDA should establish a process for the agency to communicate directly with all U.S.-based commercial airlines, including regional airlines, to encourage them to request construction inspections to ensure compliance with the agency's standards for the sanitary construction of aircraft galleys and lavatories. (Recommendation 1)

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

Comments: HHS concurs with GAO's recommendation. FDA agrees that enhancing communication with U.S.-based commercial airlines, including major national and regional commuter airlines, to encourage them to request construction inspections can have a positive impact on efforts to gain compliance with the Agency's standards for aircraft galley and lavatory sanitation and potable water system installation. FDA has a long history of working collaboratively with interstate travel conveyance stakeholders to provide public health oversight to the industry. As part of this collaboration, FDA and the airline industry connect through a variety of mechanisms to provide access to diverse industry partners. To effectively engage all relevant stakeholders, FDA will consider ways to enhance current mechanisms and coordinate with airlines on better communication. FDA will review its existing outreach channels to allow airline stakeholders to actively and directly engage with the Agency on construction inspections. FDA will review its Interstate Travel Program website to determine if updates can be made to emphasize airline construction and reconstruction information. FDA maintains open dialog with airline organizations, including the Airlines for America (A4A), the Regional Airline Association (RAA), and the International Flight Services Association (IFSA). Members of A4A are comprised of major national airlines, whereas those of RAA are comprised of regional commuter airlines and those in IFSA include airlines and airline food suppliers. These industry associations are valuable partners in developing solutions to problems that concern the airlines and airline construction. FDA will continue to engage with these organizations in written correspondence and at relevant national industry meetings (such as the Environmental Protection Agency biennial meeting on aircraft drinking water safety) and will include the topic of construction inspections. FDA will also continue to use these existing mechanisms to develop a better communication process with the airline industry on its efforts to improve industry practice and government oversight.

Recommendation: The Commissioner of FDA should, as part of the agency's efforts to update OLS's strategic plan for overseeing agency-wide laboratory safety, resolve agency-wide disagreements on the roles and responsibilities for the centers and OLS in implementing laboratory safety reforms. (Recommendation 1)

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

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Commissioner of FDA should, as part of the agency's efforts to update OLS's strategic plan for overseeing agency-wide laboratory safety, address issues of duplication, overlap, and fragmentation within the safety program. (Recommendation 2)

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

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Commissioner of FDA should, as part of the agency's efforts to update OLS's strategic plan for overseeing agency-wide laboratory safety, identify how FDA leadership will communicate agency-wide on a sustained basis about the importance of laboratory safety and OLS's role in ensuring successful implementation of laboratory safety reforms. (Recommendation 3)

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

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Commissioner of FDA should provide OLS—as FDA's laboratory oversight body—with the necessary oversight authority and access to laboratories to oversee FDA's laboratory safety program and ensure compliance with the agency's laboratory safety policies. (Recommendation 4)

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

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Commissioner of FDA should take steps to assess and mitigate any risks to independence posed by funding OLS—as FDA's laboratory safety oversight body—through the working capital fund. In conducting its risk assessment, FDA should specifically focus on ensuring the decision-making processes of the working capital fund supports OLS's independence and ability to hire sufficient staff to implement its laboratory safety oversight priorities. (Recommendation 5)

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

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Commissioner of the Food and Drug Administration, in coordination with the Secretary of Agriculture, should more fully incorporate the seven leading practices for effective collaboration in the agencies' interagency agreement for the joint oversight of cell-cultured meat. (Recommendation 1)

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

Comments: FDA and USDA partially concurred with this recommendation. FDA stated that it concurred with the intent of incorporating the seven leading practices into the interagency agreement, and both agencies said that they are open to incorporating the practices into their development of the structure for joint oversight of cell-cultured meat. However, the agencies stated that they did not agree to revise the agreement at this time. FDA and USDA stated that the agreement is a general framework and that incorporating the leading practices would constitute an inappropriate level of detail. Instead, the agencies stated that they believe it would be most valuable to incorporate the leading practices into a more detailed joint framework or standard operating procedure they plan to issue. We appreciate the agencies' willingness to incorporate the leading practices for effective collaboration into their efforts. The March 2019 interagency agreement states that the agencies have the ability to modify it as needed and will review the agreement every 3 years to determine whether they should modify or terminate it. Therefore, the agencies are due to revisit the agreement in March 2022, if not sooner. Regarding the agencies' concern that incorporating the leading practices in the interagency agreement would add an inappropriate level of detail, we note that, as we state in our report, the existing agreement already partially incorporates each of the seven leading practices. We continue to believe that FDA and USDA should more fully incorporate the seven leading practices for effective collaboration into their interagency agreement for the joint oversight of cell-cultured meat. Developing a more detailed joint framework or standard operating procedure in accordance with the existing interagency agreement that incorporates those leading practices would meet the intent of our recommendation to improve the effectiveness of the agencies' collaboration.

Recommendation: As the three cell-cultured meat working groups move forward, the Commissioner of the Food and Drug Administration, in coordination with the Secretary of Agriculture, should more fully incorporate the seven leading practices for effective collaboration, such as identifying specific outcomes and a way to monitor and evaluate progress toward outcomes. (Recommendation 3)

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

Comments: In March 2020, FDA officials agreed with this recommendation. We will follow up to determine what steps they take to implement the recommendation.

Recommendation: The Commissioner of the Food and Drug Administration, in coordination with the Secretary of Agriculture, should clearly document in their interagency agreement, or other publicly available document, which agency will oversee cell-cultured seafood other than catfish. (Recommendation 5)

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

Comments: In March 2020, FDA officials agreed with this recommendation. We will follow up to determine what steps they take to implement the recommendation.

Recommendation: The Commissioner of FDA should direct the Center for Devices and Radiological Health to conduct additional monitoring and evaluation of the status of FDA-authorized tests that rely on breakpoints, on a regular basis, to determine whether test manufacturers are updating breakpoints, seeking additional resources as needed. (Recommendation 6)

Agency: Department of Health and Human Services: Public Health Service: Food and Drug Administration: Office of the Commissioner
Status: Open

Comments: The Department of Health and Human Services and the Food and Drug Administration concurred with this recommendation. When we confirm any actions the agency has taken to implement the recommendation, we will provide updated information.

Recommendation: The Commissioner of the Food and Drug Administration should take steps to ensure appropriate agency-funded research data are readily findable and accessible to the public. (Recommendation 4)

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

Comments: The Food and Drug Administration concurred with this recommendation. When we confirm what actions the agency has taken in response to the recommendation, we will provide updated information.

Recommendation: The Commissioner of the Food and Drug Administration should evaluate training needs for agency officials or others involved in reviewing the merits of researchers' data management plans and, if additional training is found to be warranted, develop and provide such training. (Recommendation 14)

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

Comments: The Food and Drug Administration concurred with this recommendation. When we confirm what actions the agency has taken to implement the recommendation we will provide updated information.

Recommendation: The Commissioner of the Food and Drug Administration should develop and implement a mechanism to ensure researcher compliance with the public access plan and associated requirements. (Recommendation 24)

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

Comments: The Food and Drug Administration concurred with this recommendation. When we confirm what actions the agency has taken in response to the recommendation, we will provide updated information.

Recommendation: The Commissioner of FDA should establish a process to monitor whether the agency is meeting its audit goals and expectations for sampling and inspections to support its removal decisions for seafood import alerts. This could be done through regularly analyzing data that FDA collects, such as those in CMS, FACTS, and OASIS. (Recommendation 1)

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

Comments: FDA agreed with our recommendation. In August 2020, FDA told us that the agency is working to review and modify appropriate sections of its Regulatory Procedures Manual to better reflect the importance of foreign suppliers' corrective actions when making decisions to remove a firm from an import alert and identify higher-risk problem areas where more robust information may be needed. In addition, a checklist for import alerts and associated Compliance Management System (database) functionality are under development. According to FDA, the agency is also working to refine internal communications to better assure that firms which have recently been removed from an import alert are also considered for an inspection. Additionally, in November 2019, FDA published a Notice of Proposed Rulemaking on accreditation of laboratories that conduct food testing to support removal from import alert and other purposes. We will continue to monitor FDA's planned actions to determine if they satisfy our recommendation.

Recommendation: The Commissioner of FDA should establish a time frame for developing performance goals and measures for its imported food safety program. (Recommendation 2)

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

Comments: FDA agreed with this recommendation. In August 2020, FDA told us that the agency has published some performance metrics and plans to develop additional performance measures and outcome indicators for imported food safety, to support FDA's Strategy for the Safety of Imported Food (Strategy). In addition, after publishing these initial metrics for the Strategy, the agency will develop additional performance metrics. FDA stated that the COVID-19 situation is quite fluid and the agency is unable to project timelines for developing additional performance measures at this time. We will continue to monitor FDA's planned actions to determine if they satisfy our recommendation.

Recommendation: The Commissioner of FDA should, as the agency develops goals and measures for its imported food safety program, develop performance goals and corresponding performance measures specific to seafood import alerts. (Recommendation 3)

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

Comments: FDA agreed with this recommendation. In August 2020, FDA told us that the agency remains committed to developing additional performance goals and measures for its imported food safety program. FDA is still reviewing the Import Alert Effectiveness Program and will consider metrics, as appropriate, based on the outcome of that review. FDA stated that the COVID-19 situation is quite fluid and the agency is unable to project timelines for developing additional performance measures at this time. We will continue to monitor FDA's planned actions to determine if they satisfy our recommendation.

Recommendation: The Commissioner of FDA should consult with TTB and CBP to determine and document—for example in Memorandums of Understanding or other written agreements—procedures and time frames for FDA to receive quality data from TTB and CBP that will allow FDA to complete its reconciliation process in a timely manner. (Recommendation 1)

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

Comments: According to HHS, FDA officials met with CBP officials in September, 2019, and with TTB officials in October, 2019, to discuss the development of procedures and time frames for FDA to receive data from the respective entities that will allow FDA to complete its reconciliation process in a timely manner . In August, 2020, FDA reported that the agency had provided a draft agreement to both CBP and TTB subsequent to these meetings, but that agreements had not yet been finalized. Because FDA is still in the process of developing written agreements with CBP and TTB, the recommendation remains open.

Recommendation: The Commissioner of FDA should work with the Secretary of Agriculture to develop a mechanism to facilitate coordination with relevant nonfederal stakeholders, including state, local, and tribal governments, on actions related to date labels as part of their efforts to reduce food loss and waste. (Recommendation 2)

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

Comments: FDA agreed with our recommendation and is taking actions to implement the recommendation. For example, as of August 2020, FDA said it is meeting regularly with USDA and EPA to coordinate activities including to clarify and communicate information on food date labels. FDA also named a representative to the Association of Food and Drug Officials (AFDO) Food Recovery Committee. FDA is encouraging the Committee to explore how date labels on packaged foods can create a barrier to food donation and to track state legislative activities related to date labeling of food. We will update the status of this recommendation as FDA makes more progress.

Recommendation: The Commissioner of FDA should take additional steps to address inconsistency in its written comments to generic drug applicants—including the clarity of writing and the content of comments—among reviewers, such as requiring additional training for reviewers. (Recommendation 1)

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

Comments: FDA concurred with this recommendation and is taking steps to implement it. As of August 2020, FDA stated that it is evaluating methods to improve the clarity and content of primary reviewer comments by developing and providing training and work aids on written communication to ensure that FDA conveys deficiency comments in a clear and consistent manner to applicants. FDA noted that best practices on ensuring consistency in deficiency comments will be shared with primary reviewers. In addition, FDA stated that the agency is reviewing current training and providing coaching for secondary reviewers to exchange, compare, discuss, and improve the content and consistency of common deficiencies communicated in primary reviewer comments.

Recommendation: The Commissioner of FDA should assess the extent to which the timing of brand-name drug companies' drug labeling changes affect the approval of generic drug applications in the first review cycle, and take steps, as appropriate, to limit the effect of brand-name drug labeling changes on pending generic drug applications. (Recommendation 2)

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

Comments: FDA concurred with this recommendation and is taking steps to implement it. As of August 2020, FDA reported that it is identifying and assessing examples of applications in which the brand-name drug company submitted a supplemental application for a labeling change that impacted the timeline of the generic drug approval. After gathering data, FDA officials stated that they will assess what particular actions could address this issue, including whether FDA has the authority to take any such identified actions.

Recommendation: The Commissioner of FDA should work with the Administrator of EPA and Secretary of Agriculture to incorporate leading collaboration practices as they implement their interagency FLW reduction strategic plan, to include (1) agreeing on roles and responsibilities; (2) developing mechanisms to monitor, evaluate, and report on results; (3)clearly defining short- and long-term outcomes; (4) identifying how leadership commitment will be sustained; and (5) ensuring that the relevant stakeholders have been included in the collaborative effort. (Recommendation 2)

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

Comments: The agency agreed with this recommendation. As of December 2019, we are following up with the agency. When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Commissioner of FDA should develop a timeline for updating the risk assessment on arsenic in rice. (Recommendation 1)

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

Comments: As of August 2020, FDA stated that it will update the risk assessment when more scientific evidence becomes available. In the meantime, FDA noted that it will continue to monitor research in this area, including ongoing work by the National Academies of Sciences (NAS) Board on Environmental Studies and Toxicology, which is currently reviewing EPA's work on inorganic arsenic, specifically on EPA's IRIS Toxicological Assessments of Inorganic Arsenic. GAO will assess whether FDA has taken action responsive to the recommendation when additional information becomes available.

Recommendation: The Commissioner of FDA should ensure that the FVM Program develops performance measures with associated targets and time frames for all eight of FDA's food safety- and nutrition-related objectives. (Recommendation 2)

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

Comments: As of August 2020, FDA had not fully implemented our recommendation, although the agency reported taking several steps. For example, FDA stated that implementation of Food Safety Modernization Act (FSMA) based preventive controls standards is a top priority for the agency and a key component of the Foods and Veterinary Medicine Program's strategic plan, and for this reason, FSMA-related performance metrics have been prioritized. In addition, FDA reported that in September 2019, the agency published an online Food Safety Dashboard, whose purpose is to measure the progress of each of the FSMA rules, and FDA provides regular updates to the dashboard to promote transparency to the public. FDA also stated that as of June 2020, the dashboard contains measures related to Preventive Controls and Current Good Manufacturing Practice Rules and Imported Food Safety Program, and it includes data for human and animal food and, in some cases, data starting in FY 2017. FDA added that since the FSMA rules have staggered compliance dates, the measures associated with the rules are developed in phases, and over time, the Food Safety Dashboard will be populated with additional data to show more FSMA-related outcomes. However, the recommendation is not fully implemented since our recommendation included the related objectives within the Foods and Veterinary Medicine Program's strategic plan. In August 2020, FDA told us that given the agency's 2018 reorganization, FDA has aligned the performance measures and dashboard with the FSMA rules, and the current alignment covers most of the food safety objectives within the strategic plan. FDA also reported that it is reviewing the strategic plan to ensure alignment with FDA's current priorities and structure, including the recently released New Era of Smarter Food Safety Blueprint. We will follow up with FDA and provide an update in FY 2021.

Recommendation: The Commissioner of FDA should develop performance metrics and use them to evaluate the implementation of the least burdensome requirements, such as during its planned audits of medical device deficiency letters. (Recommendation 1)

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

Comments: In July 2019, FDA reported on efforts to increase device staff knowledge of least burdensome requirements and the implementation of a "least burdensome flag," which allows the submitter to flag a submission for FDA if it believes that the agency's request is not the least burdensome or that it was being held to an inappropriate review standard. In August 2020, FDA described its analysis of the flags, including the number of times it was used and the time it took to resolve them relative to FDA's goal. FDA indicated that it will continue to monitor the usage of the flag program to identify signals or trends that should be addressed. The agency indicated that the recommendation should remain open, and GAO will continue to monitor the implementation of this recommendation.

Recommendation: The Commissioner of FDA should pursue formal agreements with countries exporting seafood to the United States that commit these countries to test for drugs of concern to FDA and the corresponding maximum residue levels (MRLs) that FDA established for these drugs. (Recommendation 1)

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

Comments: FDA partially agreed with our recommendation. According to FDA, the agency is working on a plan to explore the viability of reaching cooperative arrangements with foreign regulatory bodies concerning imported aqua-cultured seafood. In exploring such arrangements, FDA stated that it will seek to explore a means by which the agency can leverage foreign regulatory bodies' seafood safety programs to provide additional oversight for seafood destined for the United States. According to FDA, such arrangements would be negotiated depending on the country's specific situation. We will continue to monitor FDA's specific efforts to implement this recommendation.

Recommendation: The Commissioner of FDA should coordinate and communicate with FSIS in developing drug residue testing methods and corresponding maximum residue levels for imported seafood that may also be applicable to imported catfish. (Recommendation 4)

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

Comments: FDA agreed with this recommendation. According to FDA officials, the agency shared its testing methods for two drugs with FSIS and as of as of April 2019, FSIS and FDA were using the same method for measuring and confirming these two unapproved drugs. In August 2020, FDA told GAO that the agencies convene quarterly to discuss emerging and ongoing research needs in laboratory method development and the establishment of drug residue limits in seafood. We commend FDA and FSIS for taking these steps to share information on testing methods. However, GAO found that the agencies continue to use different multi-residue testing methods that look for different numbers of drugs--99 for FSIS and 40 for FDA--which results in the agencies using different maximum residue levels for some drugs. FDA's method can detect drugs that FSIS's does not and can detect some drugs at lower levels. FSIS's multi-residue method can detect 59 more drugs than FDA's method. The agencies do not have any plans to work on a multi-residue method both agencies can use.

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: To help ensure that FDA's foreign offices are able to fully meet their mission of helping to ensure the safety of imported products, as the agency continues to test performance measures and evaluate its Office of International Programs (OIP) strategic workforce plan, the Commissioner of FDA should assess the effectiveness of the foreign offices' contributions by systematically tracking information to measure whether the offices' activities specifically contribute to drug safety-related outcomes, such as inspections, import alerts, and warning letters.

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

Comments: In June and July 2018 FDA reported on its recent efforts to assess the effectiveness of the foreign offices' contributions to drug-safety related outcomes. These efforts include the development of new performance measures for these offices along with a monitoring and evaluation plan; strengthened communications and collaboration between the foreign offices and FDA program centers and its Office of Regulatory Affairs; and an assessment of the foreign offices to help set their objectives and ensure the right balance of personnel, skillsets, and resources. However, FDA still had to develop intermediate outcomes to link with final outcomes. In an August 2020 written response, the agency reported that because of a reorganization and strategic planning effort for its Office of Global Policy and Strategy, it was still revising and updating its measures and its approach to evaluating impact in 2020 to align with a five-year strategic plan completed in March 2020. The agency indicated that the recommendation should remain open, and GAO will continue to monitor the implementation of this recommendation.

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 help ensure the safety of food imported into the United States, the Commissioner of Food and Drugs should complete an analysis to determine the annual number of foreign food inspections that is sufficient to ensure comparable safety of imported and domestic food. If the inspection numbers from that evaluation are different from the inspection targets mandated in FSMA, FDA should report the results to Congress and recommend appropriate legislative changes.

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

Comments: On March 25, 2020, GAO staff met with FDA officials to discuss the status of the recommendation. FDA officials said that they cannot meet the number of foreign inspections required under FSMA due to capacity constraints, and FDA's current strategy for the safety of imported food relies on a "cumulative oversight" approach involving multiple programs (including the Third-Party Certification Program, the Foreign Supplier Verification Program, the Voluntary Qualified Importer Program, and systems recognition), in addition to foreign inspections. FDA officials said that it could be a number of years before these programs are fully implemented and that FDA will provide GAO with more specific status updates on the implementation and monitoring of each of these programs in future responses to this recommendation. Because FDA is still implementing their cumulative oversight approach and has not reported the number of foreign inspections required to ensure imported food safety, the recommendation remains open.

Recommendation: To enhance its oversight of drug shortages, particularly as the agency fine-tunes the manner in which it gathers data on shortages and transitions from its database to a more robust system, the Commissioner of FDA should conduct periodic analyses using the existing drug shortages database (and, eventually, the new drug shortages information system) to routinely and systematically assess drug shortage information, and use this information proactively to identify risk factors for potential drug shortages early, thereby potentially helping FDA to recognize trends, clarify causes, and resolve problems before drugs go into short supply.

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

Comments: In September 2018, FDA told us that it was using its drug shortage data system, the "Shortage Tracker," to summarize information reported by manufacturers as the reasons for existing shortages. The agency indicated that it was developing a model that would factor in drug shortage data, warning signs identified through social media, and other factors to help identify early indicators that may predict future shortages. In July 2019, the agency indicated it could conduct periodic analyses of the causes of drug shortages. However, FDA had not yet proactively conducted any rigorous analyses of predictors of drug shortages to help recognize trends, clarify causes, and resolve problems before drugs go into short supply. In an August 2020 written response, FDA reported that it was undertaking modeling efforts to explore the feasibility of predicting future drug shortages using machine learning approaches. FDA planned to complete the initial modeling by fall 2020, at which time it would identify next steps. The agency indicated that the recommendation should remain open, and GAO will continue to monitor the implementation of this recommendation.

Recommendation: To help ensure the success of FDA's modernization efforts, the Commissioner of FDA should direct the CIO to, in completing the assessment of Mission Accomplishments and Regulatory Compliance Services (MARCS), develop an integrated master schedule (IMS) that (1) identifies which legacy systems will be replaced and when; (2) identifies all current and future tasks to be performed by contractors and FDA; and (3) defines and incorporates information reflecting resources and critical dependencies.

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

Comments: In 2018, we confirmed that FDA, in response to our recommendation, began efforts to identify which legacy systems will be replaced. FDA also developed an IMS for fiscal year (FY) 2017 and 2018 that identifies current and future tasks to be performed by contractors and FDA. However, FDA's IMS for FY 2017 and 2018 does not fully and clearly define resources. For example, although the FY 2017 IMS includes 265 names, roles, and teams, only 16 percent of activities have resource assignments. Further, FDA's fiscal year 2018 IMS does not fully define critical dependencies. For example, there are 14 activities and milestones with finish dates that are not properly tied to logic. Specifically, the finish dates of the 14 activities are not clearly tied to succeeding activities in the schedule. We contacted FDA in September and December 2019 and January 2020 for an update 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 help ensure that FDA's overseas offices are able to fully meet their mission of helping to ensure the safety of imported products, the Commissioner of FDA should ensure, as it completes its strategic planning process for the overseas offices, that it develops a set of performance goals and measures that can be used to demonstrate overseas office contributions to long-term outcomes related to the regulation of imported products and that overseas office activities are coordinated with the centers and Office of Regulatory Affairs (ORA).

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

Comments: In June and July 2018 FDA reported on its recent efforts to assess the effectiveness of the foreign offices' contributions to drug-safety related outcomes. Among other things, the agency developed new performance measures for these offices along with a monitoring and evaluation plan and conducted an assessment of the foreign offices to help set their objectives and ensure the right balance of personnel, skillsets, and resources. However, FDA still had to develop intermediate outcomes to link with final outcomes. In August 2020, the agency indicated that because of a reorganization and strategic planning effort for its Office of Global Policy and Strategy, it was still revising and updating its measures and its approach to evaluating impact in 2020 to align with a five-year strategic plan completed in March 2020. The agency indicated that the recommendation should remain open, and GAO will continue to monitor the implementation of this recommendation.

Recommendation: To better ensure FDA's oversight of the safety of GRAS substances, the Commissioner of FDA should develop a strategy to minimize the potential for conflicts of interest in companies' GRAS determinations, including taking steps such as issuing guidance for companies on conflict of interest and requiring information in GRAS notices regarding expert panelists' independence.

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

Comments: On November 16, 2017, FDA published a notification of availability for the draft guidance "Best Practices for Convening a GRAS Panel: Guidance for Industry," with a request for comments on the draft guidance by May 15, 2018. FDA indicated that the draft guidance represents FDA's current thinking on strategies to minimize the potential for conflicts of interest in companies' GRAS determinations, including assessing potential GRAS panel members for conflicts of interest. As of July 2020, FDA had not yet finalized the guidance, so we are leaving the recommendation open.