Enhancing the Participation of Public Health and Consumer Safety Nonprofit CDRH S

National Center For Health Research, Incorporated, Washington DC

Investigators

Abstract

Project Summary/Abstract The new leadership of the FDA and the Center for Devices and Radiological Health (CDRH) has expressed and shown their commitment to the public health mission of the agency and to a more transparent decision-making process. When CDRH holds stakeholder meetings, advisory panel meetings, or requests public comments, however, most participants are individuals or entities that work directly or indirectly for device companies, or with close ties to those companies. The less active participation of consumer advocate and public health nonprofit groups and individuals stems not from lack of interest, but from lack of knowledge and resources to focus on device issues. There are many opportunities for the public to learn about CDRH at meetings outside the FDA as well, such as the Institute of Medicine and Food and Drug Law Institute meetings, but these too are primarily attended by people representing the interests of the regulated companies. In an effort to bring together a larger number of independent consumer, public health, and patient perspectives with CDRH officials and staff, the National Research Center for Women &Families (NRC) respectfully requests a conference grant of $49,977. Administered by NRC, this grant would be used to convene two small working conferences that would provide a forum for learning and dialogue. They would feature presentations and participation by CDRH officials and staff, as well as 30-50 individuals and organizations representing consumer, public health, and patient perspectives on device safety and effectiveness issues. After each conference, participants would work together to develop and disseminate white papers or a proceedings summary. NRC is a 501(c)(3) health research and education nonprofit which has been particularly active on CDRH issues, and has played a leadership role in engaging the Patient, Consumer, and Public Health Coalition and other nonprofit organizations on medical device issues. The first conference would focus on CDRH approval and clearance processes and procedures, including standards of safety and efficacy. The topics of the second working conference would be determined by NRC in consultation with CDRH, and would likely focus on safety, efficacy, and performance issues related to the Medical Device User Fee Act or other policy issues related to patient education, public health or consumers as CDRH stakeholders. NRC will organize and manage the conferences, disseminate grant funds for travel and other expenses to the other nonprofit organizations participating, and work with participating organizations and individuals to produce two white papers or proceedings documents based on the two conferences. NRC has an established track record for this type of work, having received federal grants in the past to hold working conferences on health policy issues.