Last week, the US Food and Drug Administration announced the release of a new report, FDA Science Moving Forward, showcasing the agency's scientific advancements since 2007.
Major Changes Since 2007
In 2007, FDA's Science Board released a report, FDA Science and Mission at Risk, which predicted that "rapid developments" in emerging scientific disciplines such as genomics, personalized medicine and tissue- and stem cell-based therapy would pose increasingly complex scientific challenges to the agency.
To illustrate the scientific challenges faced by the agency, the report gives examples of emerging technologies that it has begun to encounter:
- "FDA is receiving an increasing number of stem cell-based products for evaluation.
- An FDA advisory committee has considered medical interventions involving manipulation of the mitochondrial genome that would prevent the transmission of severe mitochondrial diseases.
- FDA is seeing a growing number of submissions for medical devices that use computer simulations to describe how the device performs.
- FDA is increasingly using next-generation sequencing to identify sources of microbial contamination in food and other regulated products.
- FDA is receiving a growing number of regulatory submissions in which genomics data are considered in the approval and labeling supporting the development of genomically targeted therapeutics to further personalize medicine."
To keep pace with scientific innovation, the 2007 FDA Amendments Act created a new office for scientific oversight for the agency, the Office of the Chief Scientist. Since then, FDA has created several other offices to bolster its ability to meet its mandate, including the Office of Regulatory Science and the Office of Scientific Professional Development.
Advancing Regulatory Science
In 2010, FDA launched its Advancing Regulatory Science Initiative to "transform the way medical products are developed, evaluated, and manufactured [in] all FDA-regulated activities and every dimension of regulatory science, including postmarket surveillance."
The agency says it uses regulatory science to develop and apply "the best available scientific data, knowledge, methods, and tools to reduce uncertainty and make regulatory evaluation and decision-making more efficient and consistent."
In the report, FDA says it knows it must be vigilant to continue to achieve its goals, and must:
- "Be proactive in addressing emerging technologies that may become the regulated products of the future"
- "Remain current on new science and technology, so FDA can use the best available tools to evaluate existing and new products"
- "Make innovative contributions to new science and technology that reflect [the agency's] knowledge of the regulatory needs and limiting factors in product development"
- "Remain positioned to respond rapidly to public health emergencies involving … regulated products"
Eight Nine Scientific Priority Areas
In 2011, the agency built on top of its Advancing Regulatory Science Initiative by crafting a Strategic Plan for Advancing Regulatory Science.
The plan originally outlined eight scientific priority areas, though a ninth was added later in 2013:
- modernize toxicology to enhance product safety
- stimulate innovation in clinical evaluations and precision medicine to improve product development and patient outcomes
- support new approaches to improve product manufacturing and quality
- ensure FDA readiness to evaluate innovative and 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 us and global health and security
- strengthen social and behavioral science to help consumers and professionals make informed decisions about regulated products
- strengthening the global product safety net
Science Board Oversight
While FDA's Science Board has been around since 1992, it has "become increasingly engaged in programmatic reviews of FDA's product center and office regulatory science programs."
Some of the programs the Science Board has reviewed include pharmacovigilance programs at the Center for Drug Evaluation and Research (CDER) and the Center for Devices and Radiological Health (CDRH), as well as the Center for Biologics Evaluation and Research's (CBER) postmarketing safety programs and the National Antimicrobial Resistance Monitoring System.
FDA Voice, FDA Science Moving Forward