When a scientific, technical, or policy question arises, such as whether an unapproved product is safe and effective, FDA often relies on Advisory Committees to provide independent advice. Committee members include scientific experts—such as physician-researchers and statisticians—and members of the public, including a FDA Patient Representative.
Why Does FDA Use Advisory Committees?
The Federal Advisory Committee Act, or FACA, spells out the activities and operations of federal advisory committees. This ACT defines the committee as an entity that is used by an agency of the federal government to gain advice or recommendations. The ACT also states that any committee is not entirely made up of full-time government employees.
What this means is that FDA, uses advisory committees to:
- obtain advice from experts who work outside of the government.
- work towards an open and transparent government.
- encourages patients, healthcare providers and other interested people to share their views during the open public hearing or by submitting comments to the open docket.
Part of the FDA mission is to evaluate new therapies and determine which are safe and effective for their intended use. This complex job often involves many areas of expertise, and sometimes FDA turns to outside experts for counsel.
The primary role of the FDA advisory committee is to:
- provide independent expert advice to the Agency in its evaluation of these regulated products.
- help the agency move toward making sound decisions based upon reasonable application of sound scientific principles.
Advisory Committees weigh the available evidence and provide scientific and medical advice on the safety, effectiveness, and appropriate use of products that FDA regulates. Many times committees are asked to provide advice on general topics that many not be related to a one specific product, such as a class of products which would represent products group together because of how they function on the body or what diseases they may treat.FDA advisory committees are just that, advisory, in nature. Therefore the advice that it receives from the committee does not represent the position of the FDA, rather, the FDA weighs the advice that it receives when taking actions on medical products. FDA makes the final decisions on all matters that come before the committee. FDA has 49 technical and scientific advisory committees and panels.
When Does FDA Use Advisory Committees?
Advisory committee meetings can occur during any stage of a medical products review process and after a product has been approved and marketed. Typically, an advisory committee meeting is held to assist the review division with interpretation when questions or difficulties related to trial data arise.
The decision to involve an advisory committee is usually at the discretion of the director of the review division.
How and When are the Meetings Announced?
Advisory Committee Meetings are officially announced through the Federal Register and are announced at least 15 days in advance of the meeting. The announcement will include:
- Date(s) the meeting will be held.
- Time of the meeting
- Location of the meeting.
- Topics of discussion that will be discussed at the meeting.
- Web-links for further information.
- Instructions for written and in-person comments from the public.
Who Are the Advisory Committee Members?
Advisory Committee members include:
- Scientific experts, including physician-researchers, statisticians, engineers, medical faculty, chemists, biologists, and other science-oriented professionals
- Consumer representative
- Industry representative
- FDA Patient Representative
An advisory committee ordinarily consist of 9 fixed or “standing” members including the chairperson. Members are selected because they are knowledgeable in expertise specific to the committee’s function. Most committees will also have a consumer representative and an industry representative.
Qualified candidates are appointed as members for terms from 1-4 years. The committee should represent all geographic locations and be balanced as far as gender and minority status. Anyone can nominate an individual for committee membership, with the nominee’s awareness. An individual may also self-nominate.
Committees are also supplemented with persons called temporary voting members. These include patient representatives and other scientists or medical personnel whose expertise may not be represented by the fixed voting membership.
Many times, committees need to invite experts who are unrelated to the knowledge and expertise spelled out in the committee charter if a medical product or topic for discussion calls for a specific need for a particular expert.
A good example would be a drug used to treat a neurological issues and that drug and studies potentially show that the drug causes a negative impact on the liver. In this case, the PCNS committee would be supplemented with a liver specialist.
To apply for membership, visit the FDA Advisory Committee Membership Application portal
What is the Role of the Chair?
The role of the chairperson is multi-faceted and critical to the effective performance of a committee. The chairperson:
- presides over a meeting and conducts all aspects of the meeting.
- ensures that the meeting is conducted in a manner that allows for balanced presentations of the issues by both the FDA and the sponsor.
- ensures that the public participation is conducted as prescribed.
- sets the tone for the committee interaction with the sponsor as well as deliberations by the committee.
One of the most important roles of the chairperson is to:
- balance adherence to the agenda.
- protect committee discussion and deliberation time.
- assure sufficient coverage of relevant issues.
- make sure that the committee provides clear and scientifically valid advice to the FDA in a timely manner.
- make sure that the Open Public Hearing is conducted accordingly.
- make sure that the committee hears from persons who wish to speak as arranged.
The chairperson cannot perform these functions without the Designated Federal Officer, also referred to as the DFO who is primarily the “keeper of the committee”. The DFO is the primary point of contact for the agency, the public, and committee and is responsible that all functions of the committee are carried out accordingly.
The DFO also works closely with the OHCA in selecting a patient representative as well as helping OHCA to prepare a patient rep for an upcoming advisory committee meeting.
How Do Advisory Committee Meetings Work?
FDA's advisory committee program is governed by a number of Federal laws and regulations that set forth standards for holding advisory committees and reviewing potential conflicts of interest, among other things. FDA also has developed guidance documents that describe FDA's recommendations and policy related to our advisory committees.
We make these laws, regulations, and guidance documents available through our web site to provide ready access to the statutory and regulatory framework that FDA advisory committees operate within and to describe the steps that FDA has taken to enhance decision making, increase transparency, and strengthen public confidence in our advisory committee program.
- Food and Drug Administration Safety and Innovation Act (FDASIA)
- Federal Advisory Committee Act (DOC - 90KB)
- Government in the Sunshine Act (TXT - 22KB)
- 5 CFR 2640 – Interpretation, Exemptions and Waiver Guidance Concerning 18 U.S.C. 208 (Acts Affecting a Personal Financial Interest)
- 5 CFR 2635.502 Impartiality in Performing Official Duties
- Public Hearing Before a Public Advisory Committee (Code of Federal Regulation, 21 CFR Part 14)
- Public Availability of Advisory Committee Members' Financial Interest Information and Waivers - Final Guidance - February 28, 2014
- Procedures for Evaluating Appearance Issues and Granting Authorizations for Participation in FDA Advisory Committees - Draft Guidance - June 29, 2016
- Voting Procedures at Advisory Committee Meetings - Final Guidance - August 1, 2008
- Preparation and Public Availability of Information Given to Advisory Committee Members - Final Guidance - August 1, 2008
- The Open Public Hearing at FDA Advisory Committee Meetings - Final Guidance - May 15, 2013
What Are the Different FDA Advisory Committees?
The FDA has 47 Advisory Committees, one of which, the Medical Devices Advisory Committee, has 18 panels. The committees are established to provide functions which support the FDA's mission of protecting and promoting the public health, while meeting the requirements set forth in the Federal Advisory Committee Act. Committees are either mandated by statute or established at the discretion of the Department of Health and Human Services.
What Are FDA Patient Representatives?
FDA Patient Representatives play an important role in providing advice as part of the medical product approval process. OHCA identifies, screens, and places patients on specific committee meetings that best fit their background, situation, and experience. Learn more about becoming a FDA Patient Representative.