Understanding FDA Advisory Committees, Aims, and Members

December 12, 2022 - The United States Food and Drug Administration (FDA) approval process is complex and involves multiple people's input, opinions, and expertise, including the FDA advisory committees. Every time a new drug is approved, a recall is announced, or the FDA puts forth a new regulatory guideline, the FDA advisory committee plays a significant role. FDA advisory committees are composed of multiple members of varying backgrounds that evaluate certain products — or classes of products — using evidence-based approaches to provide recommendations to the FDA. According to the FDA website, the organization has 49 technical and scientific advisory committees and panels.

Purpose of Advisory Committees

The FDA notes that the purpose of the committees is to gain additional advice and insight from those outside the FDA, advance open and transparent governance, and encourage all stakeholders to share their opinions or participate in the conversation.

According to the FDA website, “the primary role of FDA advisory committees is to provide independent expert advice as we evaluate products and to help us make sound decisions based on the available science.”

Regarding regulation, the committee’s role includes evaluating product safety, efficacy, and appropriate use. This can manifest in multiple different ways. The most understood version of this comes from drug approvals. After conducting a clinical trial, companies can present their data to the appropriate FDA advisory committee, which uses it to make regulatory recommendations on the product.

The FDA may choose to convene an advisory meeting at any point during the approval process of a product. This can include early stages of review and may even happen after the product has been approved and marketed.

Anything the FDA regulates is eligible for evaluation by the advisory committee, including human and veterinary drugs, biological products, medical devices, tobacco, and food.

The committee may be asked for recommendations on a specific product; however, most of the time, the committee advises on general topics like a class of products or the uses of certain types of products.

Meetings — including date, time, location, topics, additional information, and commentary instructions — are announced 15 days or more in advance through the Federal Register, a website that publishes announcements and news from government organizations.

Recommendations by the advisory committee are non-binding, and the FDA reserves the right to oppose or alter recommendations as it sees fit. Despite that, most of the time, the FDA regulations and decisions agree with the advisory committee.

Members

Members are recruited based on their area of expertise and experience, depending on what each committee is responsible for.

The FDA recruits scientific professionals, including researchers, engineers, medical personnel, chemists, biologists, and more. Additionally, committees typically have a consumer, industry, and patient representative when applicable.

The advisory committee is made up of nine standing members, including the committee chairperson. The goal is to fill the committee with educated, qualified individuals who represent all backgrounds, including but not limited to geographic and gender backgrounds. Members are nominated or self-nominated and then evaluated. Advisory committee members serve for 1–4-year terms.

According to the FDA, “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.”

Committee members may invite additional expertise depending on the topic being discussed.

Committee Leadership

The committee chairperson oversees all aspects of the meeting: monitoring conduct, ensuring balanced presentation and time, ensuring public participation, and setting the tone for interactions.

When appointing a committee chairperson, the FDA looks for someone who can adhere to the agenda, manage time, cover all relevant issues, clarify and validate advice, and conduct an Open Public Hearing.

The chairperson works closely with the Designated Federal Officer (DFO). The FDA defines the DFO as “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.”

Qualifications for the FDA Advisory Committee

When nominating members of the committee, specific qualifications must be met. First and foremost, scientific members must be qualified in their field and be able to interpret complex data, analyze it, and apply it to public health.

The FDA provides an example, saying, “persons nominated for the Clinical Chemistry and Clinical Toxicology Devices Panel in the Center for Devices and Radiological Health should be doctors of medicine or philosophy with experience in clinical chemistry, clinical toxicology, clinical pathology, clinical laboratory medicine, endocrinology, or oncology.”

A complete curriculum vitae, acknowledgment and consent form, and at least one letter of recommendation must be included to nominate an individual. Those nominating someone else must also submit a written confirmation that the nominee is aware. Consumer representatives must also send in a cover letter detailing consumer and community organizations in which they actively participate.

To maintain an unbiased or transparent advisory board, candidates are also required to disclose financial holdings, employment, research grants, and contracts so that the FDA can evaluate conflicts of interest.

Consumer Representatives

Consumer representatives are meant to provide a consumer perspective to the advisory committee, liaise between the committee and consumers, and discuss how scientific issues impact consumers.

Industry Representatives

According to the FDA, industry members are non-voting but are present to represent how specific issues can affect the industry as a whole. They are not meant to represent particular companies or firms.

Patient Representatives

Patient representatives are recruited through the FDA Patient Representative Program. Members of this program may include patients or their caregivers and are appointed as temporary Special Government Employees. They can provide direct input and share disease, condition, and treatment experiences.

The FDA states, “Candidates are carefully recruited and trained to prepare them for various agency-sponsored meetings and activities. It’s through this engagement that we learn of patient needs, priorities, and preferences and gather meaningful data that informs medical product development and decision making.”

There are multiple requirements to be considered a patient representative. In addition to being a patient or primary caregiver, the FDA Patient Representative Program looks for objective, communicative, knowledgeable, and impartial individuals.