GAO to FDA: Get Your Act Together

Nancy Crotti

June 16, 2016

3 Min Read
GAO to FDA: Get Your Act Together

The investigative arm of congress told FDA to figure out how to use its own improvement plans, coordinate among its medical product centers, and keep better track of money.

Nancy Crotti

The U.S. Government Accountability Office issued two reports this week, telling FDA to develop measurable goals for its regulatory science work, coordinate efforts among its medical product centers, and systematically track funding for regulatory science projects.

One report criticized the agency for failing to use its own plans, issued in 2011 and 2013, to guide its regulatory work and identify priorities, and for poor coordination among its centers for biologics, drugs, and medical devices.

FDA argued that it has been difficult to measure progress in broad priority areas that are managed by multiple offices and not overseen by a specific one. It also said the underlying science is continually changing and that the adoption of discoveries from research can take years. GAO agreed, but countered that science agencies "should still have clearly established goals."

FDA also acknowledged that it has "certain infrastructure issues that call out for working across the centers," including workforce development, information technology, contracting, and financial systems.  

In the second report, GAO said it reviewed 17 projects, representing all FDA centers and offices with targeted regulatory science funding, as well as all FDA regulatory science priority areas. The agency's funding for regulatory science totaled more than $507 million from fiscal years 2010 through 2014, GAO noted.

Six centers and offices--CDRH, National Center for Toxicological Research, Office of Counterterrorism and Emerging Threats, Office of International Programs, Office of Minority Health, and Office of Women's Health--fund regulatory science projects that address multiple FDA priority areas but generally did not collect information about how funds are distributed across those priority areas, GAO wrote.

"The individual centers and offices that decide which projects to fund are either tracking the priority areas in different ways or not all," GAO said. "Systematic tracking by each center or office is needed for the agency to examine obligations across, or progress within, specific priority areas and would help the agency to strategically plan for its regulatory science initiative as a whole."

The Department of Health and Human Services, which includes FDA, agreed with the need to better keep track of funding and identified recent and planned activities of specific centers to improve such tracking.

According to FDA, the goal of its regulatory science initiative is to develop and apply the best available scientific data, knowledge, methods, and tools to reduce uncertainty and make regulatory decisions more efficient and consistent.

In February of this year, FDA identified eight priorities:

  • Modernize toxicology to enhance product safety by better understanding the relationship between patient response and preclinical toxicology findings, improving toxicology models and safety assays, advancing computational analyses.

  • Stimulate innovation in clinical evaluations and personalized medicine to improve product development and patient outcomes. FDA described this as translating new findings into safe and effective medical products, getting them to patients quickly, and identifying biomarkers and endpoints.

  • Support new approaches to improve product manufacturing and quality by assessing how new technologies affect product safety, efficacy, and quality, and applying novel technologies to product development.

  • Ensure readiness to evaluate emerging technologies.

  • Construct the IT infrastructure necessary for complex data integration to improve health outcomes

  • Enable development of medical countermeasures to protect against threats to U.S. and global health and security.

  • Strengthen social and behavioral science to help consumers and professionals make informed decisions about regulated products.

  • Strengthen the global product safety net through targeted spending and data use to manage risks.

Nancy Crotti is a frequent contributor to Qmed. Read more of her work at


About the Author(s)

Nancy Crotti

Nancy Crotti is a frequent contributor to MD+DI. Reach her at [email protected].

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