Background and Objectives
The Institute of Medicine (IOM) 2007 report, The Future of Drug Safety: Promoting and Protecting the Health of the Public, identified the need for an improved science base for drug evaluation, including both internal resources and extramural funding for collaboration with academia. A 2008 IOM Drug Forum meeting examined this question in a public workshop that explored the science of drug regulation, focusing on the gap between leading edge technologies of drug development and the capacity of the FDA to adapt the process of regulatory evaluation to these technologies. A subsequent report by the FDA Science Board examined in depth the need for an enhanced science base, including infrastructure development, multi-sectoral collaboration, and the expansion of a workforce capable of addressing the rapidly evolving science of drug discovery and development. Together these meetings and reports suggest a widening gap between the scientific developments in areas that are relevant to FDA and its ability to meet each innovation and simultaneously regulate products that make up 25% of the U.S. economy. Despite the importance and urgency to the nation of developing a sound science for regulatory decisions, there also exists a gap in understanding between the public, policymakers, and the agency on what is required to carry out such a task.
To address these concerns, the Forum on Drug Discovery, Development, and Translation convened a public workshop to examine the state of the science of drug regulation and consider approaches for enhancing the scientific basis of regulatory decision making. This workshop provided an opportunity to fully explore the concept of regulatory science, examined how it can be used to improve regulatory decision making, and considered alternative mechanisms and institutional frameworks for its development and application in regulatory decision making. It featured experts on the science of drug regulation, as well as stakeholders in drug development and the regulatory process, including representatives of patient groups, academia, government, and industry.
A range of approaches and innovative mechanisms were considered, which may include:
- fostering the scientific discipline of regulatory science;
- promoting closer collaboration between of regulatory and academic researchers; and
- developing a solid infrastructure to support regulatory science.
Specific models to be considered may include: regulatory science centers of excellence; innovative federal grant-making mechanisms; and medical education and professional development programs
Below are materials for the workshop, including an agenda and presentations.
For additional information on the workshop, including the planning committee and sponsors, please visit our project page.