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 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.