Abstract
Advisory Committees to the Food and Drug Administration provide FDA with expert advice on medical and scientific topics relevant to FDA’s responsibility to protect and promote the public health. The history and experience with Advisory Committees (since authorization in federal law in 1972) provides a rich background to inform a review of best practices. The following best practices for the Advisory Committee process are noteworthy:
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Role definition: A shared understanding of the roles of all participants in the Advisory Committee process helps to foster productive meetings and facilitates prompt resolution of potentially contentious issues.
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Transparency: FDA and sponsor should operate with transparency in bidirectional sharing of information and perspectives before, during, and after a product-specific Advisory Committee meeting.
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Regulatory knowledge: Advisory Committee members, special government employees, consultants, and sponsors must all have a fundamental knowledge of the regulatory principles governing the Advisory Committee process, as well as development and registration of drug and biologic products.
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Access and focus: FDA has an ongoing need for access to external medical and scientific experts to augment the agency’s internal experts. Consultation with Advisory Committees should be focused on situations (as described in this article) where external advice is warranted to aid FDA in efforts to protect and promote the public health.
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Training: Optimization of the Advisory Committee process and implementation of best practices across the multiple committees and reviewing divisions in FDA require training of all participants.
PhRMA member companies strive to embrace these best practices in working with reviewing divisions, the Executive Secretary of each committee, and Advisory Committees. This white paper is presented to foster further dialogue to aid continuous improvement in the Advisory Committee process.
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Cocchetto, D.M., Hassall, T.H., Carter, L. et al. Best Practices for the Advisory Committee Process for Products Regulated by CDER and CBER: A PhRMA White Paper. Ther Innov Regul Sci 42, 13–21 (2008). https://doi.org/10.1177/009286150804200104
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DOI: https://doi.org/10.1177/009286150804200104