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: 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 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.