Research · 11 min read
What an FDA Advisory Committee Does, and Who Gets to Speak
Advisory committee meetings get reported as verdicts. The regulation that governs them says something narrower: the committee advises, the Commissioner decides, and every meeting has to include an open hearing where any interested person can ask to be heard.
Key takeaways
- A committee advises; the regulation gives the Commissioner sole discretion over the action taken and the policy expressed on any matter it considered.
- Every meeting includes an open portion that constitutes a public hearing, and that portion runs at least one hour unless participation ends sooner.
- Meetings are noticed in the Federal Register before the first of each month and at least fifteen days ahead, with a defined list of contents including the agenda and the time reserved for public participation.
- To be assured of speaking, an interested person tells the Designated Federal Officer beforehand; FDA may require people with common interests to present jointly.
- Written submissions go to the Designated Federal Officer rather than to members, and a committee may set a publicly noticed cutoff date.
- No meeting may be entirely closed, and a portion is closed only under a written determination by the Commissioner.
- Voting members serve as individuals, not as representatives; nonvoting consumer and industry members vote only on procedural matters.
- Any voting member may file a separate report with additional or minority views, which is why a single vote tally is an incomplete summary.
- Any interested person may petition to have a matter about a prescription drug sent to a committee, and the Commissioner may grant or deny it.
Answer first: it advises, and the Commissioner decides
The regulation states the purpose in two sentences, and the second one is the important one.
An advisory committee is used to conduct public hearings on matters of importance that come before FDA, to review the issues involved, and to provide advice and recommendations to the Commissioner.
Then: the Commissioner has sole discretion concerning action to be taken and policy to be expressed on any matter considered by an advisory committee.
So a committee vote is an input. Headlines that treat it as a decision are describing something the regulation says it is not.
Every meeting contains an open public hearing
The rules divide a meeting into named portions, and the first one is a hearing.
Every committee meeting includes an open portion, which constitutes a public hearing during which interested persons may present relevant information or views orally or in writing.
It also has a floor. For each meeting, the open portion for public participation will be at least one hour, unless public participation does not last that long. The chairperson may extend it.
The other portions are the open committee discussion, a closed presentation of data that is prohibited from public disclosure, and closed deliberations. Public participation during the open committee discussion happens only with the chairperson's consent.
One rule sits above all of that. No committee meeting may be entirely closed, and a portion may be closed only under a written determination by the Commissioner.
How to find out a meeting is happening
The notice requirement is specific, and it is the practical answer to when to look.
Before the first of each month, and at least fifteen days in advance of a meeting, the Commissioner publishes a Federal Register notice of all advisory committee meetings to be held during that month. A meeting called after that monthly notice is announced individually, also at least fifteen days ahead.
The notice has to carry a defined set of contents. The committee name. The date, time and place. The general function of the committee. A list of all agenda items, showing whether each will be discussed in an open or closed portion.
If any portion is closed, the notice states the time of the open and closed portions, the nature of the subjects to be discussed in the closed portion, and the reasons for closing it.
It also has to state the time set aside for oral statements and other public participation, and the name, address and telephone number of the Designated Federal Officer. And it has to say that written submissions may be made through that officer at any time, unless a cutoff date has been established.
There is an emergency exception. Where an immediate meeting is required, public notice is given at the earliest time and in the most accessible form feasible. A notice published fewer than fifteen days before a meeting must include an explanation for the lateness.
How a member of the public gets to speak
The route is written down, and it runs through one person.
An interested person who wants to be assured of the right to make an oral presentation must inform the Designated Federal Officer, orally or in writing, before the meeting.
The request states the general nature of the presentation and the approximate time desired. Whenever possible, written material to be discussed should be furnished in advance, and FDA distributes it to members rather than the presenter doing so.
Before the meeting the officer decides how much time each person gets and when they go, and tells each person in writing if time permits, otherwise by telephone. FDA may require persons with common interests to make joint presentations.
At the meeting the format is deliberately informal. The hearing is informal and the rules of evidence do not apply. No motions or objections about admissibility may be made or considered, though other participants may comment on or rebut what was presented.
Questioning runs one way by default. The chairperson and other members may question a presenter; no other person may. A participant may question a committee member only with that member's permission, and only about matters before the committee.
Writing to a committee
Oral time is scarce, and the written route has fewer gates.
An interested person may submit written information or views on any matter being reviewed. Voluminous data must be accompanied by a summary.
Submissions go to the Designated Federal Officer, and not directly to a committee member. FDA distributes them to each member, either by mail or at the next meeting, and the committee considers them in its review of the matter.
A committee may establish and publicly notice a cutoff date after which submissions on a matter will no longer be received or considered. That is why the Federal Register notice has to say whether one exists.
There is a separate track for a company with an application pending. At a committee's request or the Commissioner's own initiative, FDA may ask an applicant or sponsor to present or discuss safety, effectiveness or other data at a scheduled meeting. Where a written summary is requested, it is normally due at least three weeks before the meeting.
Who is in the room, and who can vote
Committee membership has a structure that explains a lot about how these meetings read.
Voting members of a technical advisory committee must have expertise in the subject matter, with diverse professional education, training and experience so the committee reflects a balanced composition. They are subject to conflict of interest laws and regulations, generally as special government employees.
And voting members serve as individuals. The regulation says they do not serve as representatives of any group or organization that nominated them or with which they may be affiliated.
Separately, a technical committee may include nonvoting members who represent and act as liaison with interested organizations. Except where the Commissioner concludes otherwise, these are normally limited to one person selected by consumer groups and one selected by industry groups.
The consumer representative is chosen by ballot. FDA compiles a list of qualifying consumer organizations, selects three to five nominees for a ballot, sends each organization the nominees' curricula vitae, and the nominee with the most votes is selected. A tie is broken by lot.
The industry representative is chosen by industry. FDA writes to every industry organization that expressed interest, tells them it is their responsibility to consult with each other, and gives them sixty days to select a single representative. If they do not, the Commissioner selects one.
Nonvoting members may vote only on procedural matters, such as additional rules the committee adopts, approval of minutes, decisions on transcripts and future meeting dates.
How a vote actually works
The mechanics are plainer than the coverage usually suggests.
Unless the committee charter provides otherwise, a quorum is a majority of the current voting members. A matter before the committee is decided by a majority vote of the voting members present at the time.
The designated federal official may require that a final report be voted on by all current voting members rather than only those present.
And a dissent has a formal home. Any current voting member may file a separate report with additional or minority views.
That last provision is worth remembering when a vote is reported as a single number. The regulation contemplates a written minority position sitting alongside it.
What comes out afterward
Four documents are produced, and they are not the same thing.
Detailed minutes are prepared for meetings, approved by the committee and certified by the chairperson. They must include a complete and accurate description of matters discussed and conclusions reached, kept separately for the open and closed portions. They must also record the extent of public participation and list the members of the public who presented.
A transcript or recording is arranged for each portion of a meeting. The open-portion transcript goes into the record of the proceedings. The closed-portion transcript is kept confidential by FDA, is not part of the administrative record, and will not be discarded or erased.
Anyone attending an open portion may record or transcribe it themselves, consistent with orderly conduct, though that transcription is not part of the administrative record.
The advice itself is ordinarily written. Advice and recommendations on a specific drug or a class of drugs are ordinarily in the form of a written report, which may be the approved minutes or a separate document. The report responds to the specific issues or questions the Commissioner addressed to the committee, and states the basis of the advice.
That framing matters when reading one. A committee report is an answer to questions somebody else wrote.
Requests for public advisory committee records, including minutes, go through FDA's freedom of information process rather than to the committee.
Which committees are relevant here, and what they cover
The regulation carries a list of standing advisory committees with the date each was established and a statement of its function.
Two on the drug side are directly relevant to anyone following GLP-1 medications and compounded versions of them.
The Endocrinologic and Metabolic Drugs Advisory Committee carries an establishment date of August 27, 1970. Its stated function is to review and evaluate data on the safety and effectiveness of marketed and investigational human drugs for use in endocrine and metabolic disorders.
The Pharmacy Compounding Advisory Committee, re-established April 25, 2012, provides advice on scientific, technical and medical issues concerning drug compounding under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act.
A third is worth knowing by name. The Drug Safety and Risk Management Advisory Committee, established May 31, 1978, reviews and evaluates data on risk management plans and related issues.
A separate section explains what the prescription drug committees exist to do. They advise generally on safety and effectiveness, including labeling and advertising, for drugs in their pharmacologic class, and specifically on whether available information supports a particular determination in a pending matter.
Anyone can ask for a matter to go to a committee
This is the least known provision in the part, and it is short.
Any interested person may request that a specific matter relating to a particular human prescription drug be submitted to an appropriate advisory committee for a hearing, review and recommendations.
The request goes in through the agency's general petition procedure. It must demonstrate the importance of the matter and the reasons why it should be submitted for a hearing at that time. The Commissioner may grant or deny it.
The agency can also do this on its own initiative, and the regulation says which drugs get priority. Investigational drugs that are potential therapeutic advances get high priority, as do drugs that pose significant safety hazards. So do drugs presenting narrow benefit-risk considerations, drugs with a novel delivery system or formulation, and drugs that are the subject of major scientific or public controversy.
For drugs already on the market the priority list is similar. An important new use has been discovered, or newly discovered safety hazards, or major scientific or public controversy. The last trigger is the prospect of important regulatory action, such as withdrawal of approval, boxed warnings or distributional controls.
What this page does not tell you
One boundary, stated where you can see it.
Everything above describes procedure. It is drawn from the part of the regulations that governs how committees are convened, who may speak, how votes and records work, and what a committee report is.
No meeting, docket, briefing package or vote is described here, and nothing here reports what any committee has concluded about any medication. Those live in the Federal Register notices, minutes and transcripts the procedure produces, and they have to be read one at a time.
Sources
- 21 CFR Part 14 — Public Hearing Before a Public Advisory CommitteeSection 14.5(a) for the purpose of an advisory committee — conducting public hearings on matters of importance before FDA, reviewing the issues, and providing advice and recommendations to the Commissioner — and 14.5(b) for the Commissioner's sole discretion concerning action to be taken and policy to be expressed. Section 14.20(a) for the monthly Federal Register notice published before the first of each month and at least 15 days in advance, the individual notice for meetings called later, and the emergency exception; 14.20(b) for the required notice contents, including committee name, date, time and place, general function, the agenda list marked open or closed, the times and subjects and reasons for any closed portion, the time set aside for oral statements and other public participation, the Designated Federal Officer's name, address and telephone number, the statement that written submissions may be made at any time unless a cutoff date is established, and the requirement to explain a notice published fewer than 15 days ahead. Section 14.22(d) for the quorum being a majority of current voting members, decision by majority vote of voting members present, the designated federal official's power to require a final report be voted on by all current voting members, and the right of any current voting member to file a separate report with additional or minority views; 14.22(e) for attendance at open portions where space is available; 14.22(h) for closing a portion only on the Commissioner's determination. Section 14.25 for the four portions of a meeting — the open public hearing, the open committee discussion in which public participation requires the chairperson's consent, the closed presentation of data, and closed deliberations. Section 14.27(a) for the rule that no committee meeting may be entirely closed and that closure requires a written determination by the Commissioner; 14.27(b)(1) for restricting closure to the shortest possible time; 14.27(b)(2) for the reference to 5 U.S.C. 552b(c) as the closure test; 14.27(b)(4) for subjects that ordinarily may not be closed, including labeling requirements for a class of marketed drugs and devices and information previously made public. Section 14.29(a) for the open participation portion of at least one hour and the chairperson's discretion to extend; 14.29(b) for informing the Designated Federal Officer before the meeting, stating the general nature and approximate time, furnishing written material in advance, FDA rather than the presenter distributing it, the officer setting each person's time, and FDA's power to require joint presentations by persons with common interests; 14.29(f) for questioning by the chairperson and members only; 14.29(g) for questioning a member only with permission; 14.29(h) for the informal format, the inapplicability of the rules of evidence, and the bar on motions and objections about admissibility. Section 14.35(c) for requests to an applicant or sponsor to present or discuss data at a scheduled meeting and the written summary normally due at least three weeks before; 14.35(d) for written submissions by an interested person, the summary requirement for voluminous data, submission to the Designated Federal Officer rather than to a member, distribution to members and consideration by the committee, and a publicly noticed cutoff date. Section 14.60(a) and (b) for detailed minutes, their approval by the committee and certification by the chairperson, and their required contents including a complete and accurate description of matters discussed and conclusions reached kept separately by portion, the extent of public participation, and a list of members of the public who presented. Section 14.61(a) through (e) for arranging a transcript or recording of each portion, inclusion of the open-portion transcript in the record, confidential retention of a closed-portion transcript that will not be discarded or erased, and the right of a person attending an open portion to record or transcribe it. Section 14.65(c) for records requests going through FDA's freedom of information process. Section 14.80(b)(1) for the expertise, diversity and conflict of interest requirements for voting members of technical committees and (b)(2) for nonvoting members serving as representatives of and liaison with interested organizations. Section 14.82(d) for voting members serving as individuals and not as representatives of any group or organization. Section 14.84(b) for the normal limit of one consumer-selected and one industry-selected nonvoting member; 14.84(c) for the 30-day nomination period, the compiled list of consumer organizations and the right of any qualifying organization to be added, selection of three to five nominees for a ballot, circulation of curricula vitae, selection of the nominee with the most votes and the tie broken by lot; 14.84(d) for the industry selection process, the letter to interested organizations, the 60-day period for them to select a single representative, and the Commissioner's selection if they do not. Section 14.86(a)(1) for nonvoting members voting only on procedural matters such as additional rules, approval of minutes, decisions on transcripts and future meeting dates. Section 14.100(c) for the standing committees named here with the dates and functions the regulation prints: the Endocrinologic and Metabolic Drugs Advisory Committee, established August 27, 1970, reviewing and evaluating data on the safety and effectiveness of marketed and investigational human drugs for use in endocrine and metabolic disorders; the Pharmacy Compounding Advisory Committee, re-established April 25, 2012, providing advice on scientific, technical and medical issues concerning drug compounding under sections 503A and 503B; and the Drug Safety and Risk Management Advisory Committee, established May 31, 1978, reviewing and evaluating data on risk management plans and related issues. Section 14.160 for what the standing technical advisory committees for human prescription drugs advise on, generally and specifically. Section 14.171(b) for the drugs given high priority for hearing and review, both investigational and marketed. Section 14.172 for any interested person's request that a specific matter about a particular human prescription drug be submitted to a committee, the requirement to demonstrate importance and timing, and the Commissioner's power to grant or deny. Section 14.174 for advice and recommendations ordinarily taking the form of a written report, which may be the approved minutes or a separate report, responding to the specific issues or questions the Commissioner addressed to the committee and stating the basis of the advice.
Frequently asked questions
Does an FDA advisory committee decide whether a drug is approved?
No. The regulation states that a committee is used to conduct public hearings, review the issues and provide advice and recommendations to the Commissioner. It then states that the Commissioner has sole discretion concerning action to be taken and policy to be expressed on any matter the committee considered. A vote is an input to a decision that someone else makes.
Can a member of the public speak at one of these meetings?
Yes, and the opportunity is built into the structure. Every committee meeting includes an open portion that constitutes a public hearing, during which interested persons may present relevant information or views orally or in writing. That portion runs at least one hour unless public participation does not last that long. To be assured of speaking, an interested person must inform the Designated Federal Officer before the meeting, stating the general nature of the presentation and the approximate time desired.
How much notice is given before a meeting?
A Federal Register notice appears before the first of each month covering all advisory committee meetings that month, and at least fifteen days in advance of any meeting. Meetings called after the monthly notice are announced individually, also at least fifteen days ahead. A notice published fewer than fifteen days before a meeting must include an explanation for the lateness, and an emergency exception allows notice at the earliest time and in the most accessible form feasible.
Can a whole meeting be held in private?
No. The regulation states that no committee meeting may be entirely closed, and that a portion may be closed only in accordance with a written determination by the Commissioner. A determination to close restricts the closing to the shortest possible time. The regulation also lists subjects that ordinarily may not be closed. Two of them are consideration of labeling requirements for a class of marketed drugs, and review of information on specific investigational or marketed products that has previously been made public.
Who sits on a committee, and do they represent anyone?
Voting members of a technical committee must have subject matter expertise and diverse professional backgrounds, and are subject to conflict of interest laws, generally as special government employees. The regulation says voting members serve as individuals, not as representatives of any group that nominated them. A committee may also include nonvoting members, normally one selected by consumer organizations and one selected by industry organizations, who may vote only on procedural matters such as minutes and meeting dates.
How is the consumer representative chosen?
By a ballot of consumer organizations. FDA publishes a Federal Register notice requesting nominations and allows thirty days. It compiles a list of organizations whose objectives are to promote consumer education and the resolution of consumer problems, and any organization meeting the criteria may ask to be added. FDA then selects three to five qualified nominees for a ballot, circulates their curricula vitae to those organizations, and the nominee receiving the most votes is selected. A tie is broken by lot.
Is there a written record of what happened?
Several. Detailed minutes are prepared, approved by the committee and certified by the chairperson, and must describe the matters discussed and conclusions reached and list members of the public who presented. A transcript or recording is arranged for each portion; the open-portion transcript is part of the record, while a closed-portion transcript is kept confidential and will not be discarded or erased. Advice on a drug is ordinarily given as a written report responding to the specific questions the Commissioner posed. Requests for committee records go through FDA's freedom of information process.
Can an outsider ask FDA to put something in front of a committee?
Yes. The regulation says any interested person may request that a specific matter relating to a particular human prescription drug be submitted to an appropriate advisory committee for hearing, review and recommendations. The request goes in through the agency's general petition procedure and must demonstrate the importance of the matter and why it should be heard at that time. The Commissioner may grant or deny it.