On June 13, the FDA is holding a Listening Session: Optimizing FDA’s Use of & Processes for Advisory Committees to solicit public input on the advisory committee system. For information on this virtual public meeting, see here.

At the U.S. Food & Drug Administration, we rely on our many advisory committees to help us make sound decisions based on the best science available.

The FDA’s complex & multifaceted mission includes evaluating new medical devices & medicines, including vaccines & other therapies, to determine if they are safe & effective for their intended use. FDA advisory committees give our own agency experts outside, independent, & professional advice on various complex scientific, technical, & policy issues.

Advisory committee meetings can include a broad scientific discussion about important topics. They can also be more focused on a specific product under FDA review.

Expertise, Transparency, & an Outside Viewpoint

The FDA currently has 50 technical & scientific advisory committees & panels that include scientific experts & members of the public.

Members are selected by their expertise to meet the needs of each specific committee’s function & topic area. Science-oriented professionals – such as physician-researchers, statisticians, engineers, medical faculty, chemists, & biologists – are represented on the committees.

In addition, each committee typically includes a consumer representative & an industry representative &, based on the meeting topic, a patient representative who provides the patient or caregiver experience for a particular disease, condition, or medical product.

The FDA uses advisory committees to:

  • Get advice from experts who work outside the agency.
  • Work toward an open & transparent government.
  • Encourage patients, health care providers, & other interested people to share their views during the open public hearing or by submitting comments to the open docket.

Committees Provide Scientific, Medical Advice

The primary role of FDA advisory committees is to provide independent expert advice as we evaluate products, which helps us make sound decisions based on the available science.

The committees review & evaluate data about the safety, effectiveness, & appropriate use of products that are intended for use in the prevention, treatment, mitigation, or diagnosis of human diseases & conditions – & any other products the FDA regulates. These include issues related to human drugs, biological products, medical devices, tobacco, & toxicology. Committees also consider general policy matters & the quality & relevance of the FDA’s research program, which provides scientific support for the regulation of these products.

The committees’ discussions are designed to help ensure that the public is clear about the FDA’s expectations for data to support the safety & effectiveness of products, so that the public can be confident that the required regulatory standards will be met.

This process is transparent & independent, & open to the public. Members of the public have an opportunity to address the committee & share their insight.

Advisory committees make nonbinding recommendations to the FDA, which generally follows the recommendations but is not legally bound to do so. The available science & data guide the agency’s decision-making.

The FDA generally makes advisory committee meeting materials available to the public no later than two business days before any meeting. These materials include an agenda & background information from the FDA & other information as appropriate.

These committees are a valuable resource & make important contributions to FDA’s decision-making processes. For more information about the FDA’s advisory committees & how to participate, contribute, or join, see:

  • Learn About FDA Advisory Committees
  • Guidelines for Speakers at the Open Public Hearing of an FDA Advisory Committee Meeting
  • Calendar of Public Meetings