Readers may not be aware that the FDA has a number of approaches to gather feedback on regulations, programs, and other proposed changes to how the agency operates. One of the ways the agency obtains independent expert advice on scientific, technical, and policy issues is through 50 Advisory Committees. Each committee supports a specific division with advice on a focused topic (for example, drug safety and risk management, toxicological research, or cancer drugs). Committee membership includes personnel with medical, scientific, and industry credentials as well as consumer representatives. Each member is expected to “analyze scientific data, understand research design, discuss benefits and risks, and evaluate the safety and efficacy of products under review”. Industry members are expected to act on behalf of the regulated industry and notas a representative of their sponsor or firm. Patient representatives (either diagnosed patients or their caregivers) are also sought to provide advocacy for specific conditions (see the current list here). The committees meet 1-4 times per year and these meetings are announced on the FDA website and in the Federal Register (here is the link to the Patient Engagement Advisory Committee meeting on November 15, 2018). You may read more about the composition and work of the Advisory committees at the main committee website, which includes links to webcasts and materials from previous meetings as well as updates on the planned meetings for each committee.

Text Copyright © 2018 Katrina Rogers