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Aug 18, 2011

FDA Details Strategy for Overhauling Regulatory Science Used in Review Process

FDA Details Strategy for Overhauling Regulatory Science Used in Review Process

“Strategic Plan for Regulatory Science” vows agency collaboration with industry, academia. [© Yabresse - Fotolia.com]

    The FDA has issued its blueprint for overhauling the science it uses to develop and evaluate food, medicines, and medical devices, contending that it will help the agency foster innovation through better science without compromising on safety.

    The “Strategic Plan for Regulatory Science,” released Wednesday, describes how the agency plans to improve its processes for developing and evaluating new products and materials from cell therapy, tissue engineering, genomics, and personalized medicine as well as non-life science fields such as advanced computing and information technology.

    “As new discoveries yield increasingly complex products, this strategic plan ensures that our experts are equipped to make science-based decisions resulting in sound regulatory policy," FDA commissioner Margaret A. Hamburg, M.D., notes.

    FDA’s strategic plan expands on the agency’s Regulatory Science Initiative, outlined in October, 2010. The plan identifies eight priority areas for enhancing regulatory science, which FDA defines as the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products.

    One of the eight priorities identified by FDA is to “stimulate innovation in clinical evaluations and personalized medicine to improve product development and patient outcomes.” To that effect, the plan states that FDA will “utilize large, pooled clinical trial datasets to identify potential trial endpoints, explore differences in specific populations and subpopulations (e.g., stage of disease, chronic disease states, sex, race and ethnicity, pediatrics and other age groups) and different subsets of diseases, improve understanding of relationships between clinical parameters and outcomes, and evaluate clinical utility of potential biomarkers.

    In addition to leveraging existing and future clinical trial data, the agency said its implementation strategy would include working with industry, academic, and government representatives to develop and refine clinical trial designs, endpoints, and analysis methods; identify and qualify biomarkers and study endpoints; increase the accuracy and consistency as well as reduce inter-platform variability of analytical methods to measure biomarkers; and develop a virtual physiologic patient by encouraging development of computer models that incorporate radiological imaging data of healthy and diseased anatomy from a range of relevant diseases.

    The agency says that it will ensure integration of those models with genomic and other physiological data to promote development of complete physiological models and simulations for use in the development and testing of medical products.

    Other priorities identified by FDA:

    • modernize toxicology to enhance product safety.
    • 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
    • implement a new prevention-focused food safety system to protect public health
    • Facilitate 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

    “FDA must make decisions based on the best available scientific data and using the best tools and methods available in order to ensure products meet the highest quality standards for consumers while at the same time fostering and advancing innovation in the products it regulates,” according to the plan.

    In a post on the agency’s FDA Transparency blog, Vicki-Seyfert-Margolis, Ph.D., an advisor to FDA chief scientist Jesse Goodman, M.D., says the strategic plan “signals clearly the agency’s intent to work collaboratively with our colleagues in academia and industry.”

    FDA has been stung by criticism in recent years by some life science industry leaders and lawmakers that it has maintained an overly adversarial relationship with industry through overly long reviews for new drugs and other examples of excessive red tape.

    In June U.S. Sen. Scott Brown (R-MA) told a group of biotechnology executives: “Right now, there is a complete breakdown between what’s happening at the FDA and what your needs are,” and that the agency is “throwing a wet blanket” on innovation in the medical device and biotech industry, according to numerous local news reports. FDA responded by releasing figures showing that since 2002, with the exception of 2008, the agency has approved more original drug products every year than all other countries in the world combined.


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