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FDA aims to modernise regulatory science

The US Food and Drug Administration has issued a report outlining new plans to improve its performance in regulatory science

The US Food and Drug Administration (FDA) has issued a report outlining new plans to improve its performance in regulatory science, which the agency defines as "the science of developing new tools, standards and approaches for assessing the safety, efficacy, quality and performance of FDA-regulated products."

In remarks at the National Press Club in Washington, DC during a presentation unveiling the report, FDA commissioner Margaret Hamburg said that regulatory science has thus far been "underappreciated and underfunded." Hamburg said the FDA will spend $25m in 2011 on partnerships with scientists from academia, government and industry around the country aimed at furthering regulatory science. In addition, a new office dedicated to regulatory science will be established within the FDA.

"There's a troubling gap between advances in science and available patient care," the FDA commissioner said. "We need to build a bridge across this gap, and that bridge in my view is regulatory science…Regulatory science must help develop the knowledge and tools to translate discovery and innovation into products.  We cannot take advantage of the breakneck speed of biomedical research unless we also embrace innovation in regulatory science."

In fiscal year 2011, the FDA will also focus on supporting studies in four major regulatory science research areas: Transforming Product Development for Patients (including methods for modernising toxicology, biomarkers for personalised medicine, the stem cell initiative and updating drug review standards); Science to Address Emerging Technologies in FDA-Regulated Products (including nanotechnology and expertise to regulate new animal biotech products); Information Sciences for Health Outcomes (such as the medical device registry and scientific computing for data analyses) and Addressing Unmet Public Health Needs.

In the area of modernising safety testing, regulatory science investments will focus in part on biomarkers for better risk protection "to improve both animal and non-animal models and create bridges between them," the FDA said, with the goal of replacing exposure experiments with predictive markers.

"These approaches require new instrumentation, platforms, and databases, and training for FDA scientists to enable them to use and interpret data from these approaches," the report states. "Collaboration with academia, industry and sister government agencies will be critical."

7th October 2010

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