Convener of Discussions on Medical Policy Issues Impacting Drug Development

美国食品和药物管理局(FDA)寻求通过确保市场上销售的 医疗产品是安全的，并为患者带来有意义的好处。为了应对技术进步， 在基础生物医学研究和产品开发方面，FDA不断致力于新的技术、科学、 和方案方面的挑战，以确保及时批准安全有效的疗法，并推动 监管科学。作为这项工作的一部分，药物评价中心的医疗政策办公室(OMP) FDA的CDER(CDER)发布了一份申请，以支持开展以下活动的召集活动 主要利益相关者和公众对与药物开发、审查和 售后安全监控。 合作协议的主要目标将是召集一系列不同的利益相关者团体 关于一系列技术、政策和程序问题的活动，以支持OMP在推进 医疗政策和监管科学。恩格尔伯格医疗改革中心(The Center) 布鲁金斯学会与FDA合作应对具有挑战性的监管政策的历史由来已久 问题，非常适合于支持OMP的工作，其创新的召集方法建立在 学识、中立性、领导力和与不同利益相关群体打交道的经验。召集主题可 包括： 扩展上市后安全监控和上市后证据生成能力； 加强监管科学和方法，以支持加快药物开发； 激励未得到满足的医疗需求关键领域的发展；以及 支持新监管计划的实施。 每个项目活动都将经过量身定做，以通过议程成功解决潜在的争议性话题 旨在关注关键问题，有针对性的陈述和代表不同观点的小组讨论， 以及分配大量时间用于由经验丰富的领导人主持的富有成效的讨论。该中心将 通过查阅相关文献，进行深入的背景研究，以支持召集活动； 与主要专家进行深入讨论，分析现有和新出现的政策，并进行监测 与FDA的使命和目标相关的话题的最新趋势和观点。以支持有效和 与公众进行透明的沟通和接触，该中心将制定和传播 详尽、简洁和有意义的材料，将在布鲁金斯学会的网站上提供。

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.