GAO outlines priority recommendations for FDA

Regulatory NewsRegulatory News | 27 May 2021 |  By 

In a report to the Department of Health and Human Services (HHS) published on Thursday, the Government Accountability Office (GAO) outlines five priorities for the US Food and Drug Administration (FDA) to address to meet its public health mission.
In the report, addressed to HHS Secretary Xavier Becerra, GAO calls for Becerra’s personal attention in addressing 61 open priority recommendations for the department and its sub agencies, 43 of which are holdovers from last year’s report and 18 which are new for this year.
In total, GAO says HHS has 458 open recommendations, with a four-year implementation rate of 64 percent, lower than the government-wide average of 77 percent.
FDA recommendations
The first priority recommendation GAO has prescribed for FDA is for the agency to ensure it addresses its looming inspections backlog that has resulted from travel restrictions and safety concerns amid the COVID-19 pandemic. Earlier this year, GAO released a report outlining its concerns regarding FDA’s inspectional oversight amid the pandemic and the potential impact an inspections backlog could have on the agency’s inspection goals. (RELATED: FDA’s inspection backlog: GAO raises concerns as delays mount, Regulatory Focus 9 March 2021; FDA tallies pandemic inspection toll, issues new 'resiliency roadmap', Regulatory Focus 5 May 2021).
Specifically, GAO says that FDA should, “as inspection plans for future fiscal years are developed, ensure that such plans identify, analyze, and respond to the issues presented by the backlog of inspections that could jeopardize the goal of risk-driven inspections.”
The next recommendation relates to FDA’s foreign drug inspection program, which has been on GAO’s watch list for since 2016. (RELATED: Do FDA’s foreign offices help keep US drugs safe? GAO says answer is unknown, Regulatory Focus 18 January 2017).
While GAO says that FDA has made strides to improve its foreign drug inspection program and has developed new performance measures and an evaluation plan for its foreign offices, the report says that FDA has “not provided evidence of progress toward implementing [GAO’s] recommendation.”
As such, the report calls for the FDA commissioner to “assess the effectiveness of the foreign offices’ contributions to drug safety 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.”
The remaining three priority open recommendations pertain to drug residues for imported seafood, the safety of imported food and FDA and the US Department of Agriculture’s (USDA) pesticide residue monitoring programs.


© 2023 Regulatory Affairs Professionals Society.

Tags: FDA, GAO, inspections, US

Discover more of what matters to you

No taxonomy