FDA Advisory Committees: The Role of Statisticians

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The Food and Drug Administration (FDA) convenes an advisory committee to provide feedback about the strength of evidence supporting approval of a medical product such as a drug, device, or biologic. Meetings are educational and open to the public, although outsiders may speak only during the open public hearing portion and only when called on by the chair. The advisory committee typically answers several specific questions posed by the FDA and then votes on whether the evidence is sufficient to approve the product.

An advisory committee consists of outside experts—doctors in the disease area under study, biostatisticians, epidemiologists, a patient/consumer representative, and a (non-voting) industry representative—with no major conflicts of interest. Members receive briefing materials well in advance of a meeting. These include analyses of data performed by both the sponsor and the FDA, along with arguments for or against the product under study. They do not include a data set for panel members to perform their own analyses. It is helpful to read the FDA document first. Knowing the FDA’s issues makes it easier to review the sponsor’s document.

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