GAO’s recommendations database contains report recommendations that still need to be addressed.
GAO’s priority recommendations are those that we believe warrant priority attention.
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As of October 25, 2020, there are 4812 open recommendations, of which 473 are priority recommendations. Recommendations remain open until they are designated as Closed-implemented or Closed-not implemented.
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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.
