This proposal is to support research and writing of a book, ?Medicine by Committee: Expert Advice and Health Care in Modern America,? that examines the emergence, evolution, and continuing influence of expert advisory committees in American medicine and public health from the 1960s to the present. The activities of scientific expert advisory committees are among the most visible aspects of the federal government's regulation of pharmaceuticals, vaccines, and screening technologies, as well as recommendations regarding their use. Advisory committee recommendations so frequently mirror subsequent government decisions that the rare cases in which health agencies do not follow the guidance of their advisors often result in public scrutiny, concern, and allegations of political interference in science. Also, as part of the Affordable Care Act, favorable recommendations from select expert advisory panels regarding vaccines, cancer screening technologies such as mammography, and other preventive health services serve as coverage requirements for private insurance plans, thereby directly affecting access to and affordability of these health interventions. The proposed book traces the creation, development, and dissemination of this model for decision-making that established formal mechanisms for ongoing contributions from outside scientific and medical experts in the day-to-day work of government agencies evaluating specific biomedical products and practices. From the origins of this model at the Food and Drug Administration (FDA) in the 1960s through the present-day work of the Advisory Committee on Immunization Practices at the Centers for Disease Control and Prevention, the U.S. Preventive Services Task Force, and FDA Nonprescription Drugs Advisory Committee, the book shows how expert advisory committees have served as profoundly significant venues through which federal health officials have negotiated and strengthened their relationships with professional and lay communities. Expert advice has also been thought by its proponents to increase the perceived legitimacy of agency decisions, and it establishes more open deliberative processes in which professional communities, patients, and the public had greater visibility and access (in some cases serving as formal voting members), in part procedural solutions to the unavoidable subjectivity associated with government decision-making in these areas. Using advisory committee meeting minutes and transcripts, archival and other documentary materials from government agencies, the scientific and medical literature, media accounts, other primary and secondary sources, and interviews with key participants in these activities over the past half-century to the present, the book explores how expert advice in health regulation and policy grew from an experiment to an institution. It will be the first extended examination of expert advice to government in health and medicine, a project that will benefit from and contribute to larger discussions of expertise, risk, and related topics in health and biomedicine.
The activities of federal advisory committees directly influence whether pharmaceuticals are approved for use by patients and health care providers, which vaccinations are recommended for children and adults, and whether health insurance providers are required to provide coverage for particular preventive services, among their many other roles. The controversies that have followed recent advisory committee recommendations and the concerns expressed from health officials, patient groups, and the medical community may reflect, in part, an incomplete understanding of the roles of these bodies, their deliberative and decision-making processes, and their relationships with the government health agencies whose work they support. This project will provide new perspectives on these influential voices in American public health and medicine, and it will facilitate a fuller understanding of how their work?in tandem with the government health agencies they advise?is intended to best promote the broad use of safe, effective, and valuable health interventions for individuals and communities alike.
