Regulatory Focus™ > News Articles > GAO Offers Sharp Critique of FDA’s Lack of Measurable Regulatory Science Goals

GAO Offers Sharp Critique of FDA’s Lack of Measurable Regulatory Science Goals

Posted 15 June 2016 | By Zachary Brennan 

GAO Offers Sharp Critique of FDA’s Lack of Measurable Regulatory Science Goals

The Government Accountability Office (GAO) on Wednesday released two reports criticizing the Food and Drug Administration (FDA), one that says FDA lacks measurable goals to assess its progress in advancing regulatory science, and another that says FDA should better coordinate between its medical product centers.

On the regulatory science front, GAO notes that FDA issued strategic planning documents in 2011 and 2013 to guide its regulatory science and identify priority areas, “but these documents do not specify the targets and time frames necessary for the agency to measure progress overall or within each of the eight priority areas related to medical products.”

The goal of FDA’s work on regulatory science, which GAO said is nearly impossible to track or know if it’s been reached, is to “develop and apply the best available scientific data, knowledge, methods and tools to reduce uncertainty and make regulatory decisions that are more efficient and consistent.” As of February, FDA identified the following eight priorities:

  • Modernize toxicology to enhance product safety, particularly in terms of reducing gaps in understanding the relationship between patient response and preclinical toxicology findings, improving toxicology models and safety assays and advancing computational analyses;
  • Stimulate innovation in clinical evaluations and personalized medicine to improve product development and patient outcomes, which the agency said means translating new findings into safe and effective medical products, speeding efficacious medical products to patients, and identifying biomarkers and endpoints;
  • Support new approaches to improve product manufacturing and quality;
  • Ensure FDA readiness to evaluate innovative emerging technologies;
  • Harness diverse data through information sciences to improve health outcomes;
  • Facilitate development of medical countermeasures to protect against threats to US and global health and security;
  • Strengthen social and behavioral science to help consumers and professionals make informed decisions about regulated products; and
  • Strengthen the global product safety net.

But GAO, in its 50-page report, took particular issue with the agency’s understanding of how those priorities are being met, going even so far as to say that “FDA does not have the information necessary to track funding and conduct strategic planning agency-wide for its regulatory science priorities because most of the centers and offices did not collect information on the FDA priority areas that were addressed by the projects they funded.”

More specifically, GAO said that one of FDA’s centers that targets funding for regulatory science has a plan to track the progress of its regulatory science activities, “but this plan does not include measurable goals that could be used to assess progress. Specifically, CDRH [Center for Device and Radiological Health] officials told us the center has drafted a logic model to identify and track the short- and long-term outcomes of funds it spends on regulatory science research. The center expects the model to be finalized in 2017. However, the current draft does not include measurable goals to assess progress. In addition, officials from most of the other centers and offices that obligated funds targeted at regulatory science activities in fiscal years 2010 through 2014 told us they are not developing such a model. One office also stated that the CDRH model may not be applicable to their work and that they may not have the resources needed to customize and implement such a model.”

As far as GAO recommendations to improve FDA’s strategic planning for regulatory science, GAO says the Secretary of Health and Human Services should direct FDA Commissioner Robert Califf to develop and document measurable goals, such as targets and time frames, for its regulatory science efforts so it can consistently assess and report on the agency’s progress in regulatory science efforts, and systematically track funding of regulatory science projects across the priority areas.

Coordination Between Centers

In a second report released on Wednesday, GAO also criticized FDA’s management plan for its biologics, drugs and medical device centers, saying the plan “does not incorporate leading practices for strategic planning or document a comprehensive strategy for the centers.”

Of the 30 efficiency initiatives across the centers, FDA officials identified eight that have formal evaluations (such as third-party assessments), GAO said in the 52-page report, and nine that are assessed informally (such as by gathering feedback). But for the remaining 13, FDA officials said they are either exploring effectiveness measures or have no plans to assess them because they consider it to be unnecessary or impractical.

GAO recommends that the Secretary of Health and Human Services direct Califf to engage in a strategic planning process to identify challenges that cut across the medical product centers and document how it will achieve measurable goals and objectives in these areas.

MEDICAL PRODUCT OVERSIGHT FDA Needs More Strategic Planning to Guide Its Scientific Initiatives

FOOD AND DRUG ADMINISTRATION Comprehensive Strategic Planning Needed to Enhance Coordination between Medical Product Centers

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