The US Food and Drug Administration (FDA) has a released a new Strategic Plan for Regulatory Science which outlines a sweeping modernisation of the science used in developing and evaluating the products over which it has oversight.
"The core responsibility of FDA is to protect consumers by applying the best possible science to its regulatory activities - from pre-market review of efficacy and safety to post-marketing product surveillance to review of product quality," according to the Strategic Plan.
"In the last few years, rapid advances in innovative science have provided new technologies to discover, manufacture and assess novel medical products," it says, adding: "FDA must both keep pace with and utilise these new scientific advances in order to accomplish its mission to protect and promote the health of our nation."
The Plan outlines the FDA's aims to collaboratively enhance the process for developing and evaluating promising new products and novel materials from fields such as cell therapy, tissue engineering, genomics, personalised medicine, advanced computing and information technology.
It also emphasises the agency's intent to study and improve how it communicates health information to consumers, particularly as communication technologies rapidly evolve and change the way people receive that information.
"FDA will advance regulatory science to speed innovation, improve regulatory decision-making and get safe and effective products to people in need. 21st century regulatory science will be a driving force as FDA works with diverse partners to protect and promote the health of our nation and the global economy," according to the Plan's vision statement.
Specifically, the document identifies eight priority areas of regulatory science where it sees new or enhanced engagement as being essential. These require the agency to:
- modernise toxicology to enhance product safety;
- stimulate innovation in clinical evaluations and personalised medicine to improve product development and patient outcomes;
- 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-based food safety system to protect public health;
- facilitate development of medical countermeasures to protect against threats to US and global health and security; and
- strengthen social and behavioural science to help consumers and professionals make informed decisions about regulated products.
The agency will apply available resources to implement the Strategic Plan through management of scientific programmes within the FDA and the engagement of collaborators and partners within industry, academic and government, it says.
FDA-regulated products account for about 25 cents of every dollar spent by American consumers each year, and the breadth and scope of the agency's oversight is "extraordinary, touching the lives of every American," commented FDA Commissioner Margaret Hamburg.
"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. It positions us to foster innovation through better science without compromising our high safety standard," she added.
"New technologies provide unprecedented opportunities to prevent and cure disease and to grow our high-tech economy," said FDA Chief Scientist Jesse Goodman. "This plan will help turn advances in science into products that benefit people and help assure that happens more quickly and safely."
"It is a win-win-win, because it will help the public, the agency and developers of new products," he added.
