Convener of Discussions on Medical Policy Issues Impacting Drug Development

Duke University, Durham NC

Investigators

Linked publications & trials

Abstract

The U.S. Food and Drug Administration (FDA) seeks to protect public health by ensuring that marketed medical products are safe and deliver meaningful benefits to patients. In order to respond to advances in basic biomedical research and product development, FDA is continually addressing novel technical, scientific, and programmatic challenges to ensure the timely approval of safe and effective therapies and to advance regulatory science. As part of this work, the Office of Medical Policy (OMP) in the Center for Drug Evaluation and Research (CDER) at FDA issued a request for applications to support convening activities that engage key stakeholders and the public on medical policy issues related to drug development, review, and postmarket safety surveillance. The primary objective of the cooperative agreement will be to convene diverse stakeholder groups in a series of activities on a range of technical, policy, and procedural issues to support OMP?s work in advancing medical policy and regulatory science. The Engelberg Center on Health Care Reform (the Center) at the Brookings Institution has a long history of collaborating with FDA to tackle challenging regulatory policy issues, and is ideally suited to support OMP?s work with its innovative convening approach built around scholarship, neutrality, leadership and experience with diverse stakeholder groups. Convening topics may include: ? Expanding postmarket safety surveillance and postmarket evidence generation capabilities; ? Enhancing regulatory science and methods to support expediting drug development; ? Incentivizing development in critical areas of unmet medical need; and ? Supporting the implementation of the new regulatory programs. Each project activity will be tailored to successfully tackle potentially controversial topics through agendas designed to focus on the critical issues, targeted presentations and panels which represent diverse views, and significant time allocated for productive discussions moderated by experienced leaders. The Center will conduct thorough background research to support convening activities by reviewing the relevant literature, conducting in-depth discussions with key experts, analyzing existing and emerging policies, and monitoring current trends and opinions on topics relevant to FDA?s mission and goals. To support effective and transparent communication and engagement with the public, the Center will develop and disseminate thorough, concise, and meaningful materials which will be available on the Brookings website.