The record a meeting with the FDA leaves behind

Anyone can ask for a meeting

The rule on meetings is more open than most people assume, and it starts with a sentence that applies to everybody.

"Every person outside the Federal Government may request a private meeting with a representative of FDA in agency offices to discuss a matter." The agency will make reasonable efforts to accommodate such requests.

The requester may bring a reasonable number of employees, consultants or others with whom there is a commercial arrangement of the kind the disclosure rules define.

Nobody can be forced into the room. Neither the agency nor anyone else may require the attendance of a person who is not a federal executive branch employee without the requester's agreement.

The agency picks its own attendees, with a limit on how far the requester's preferences run: "The person requesting the meeting may request, but not require or preclude, the attendance of a specific FDA employee."

And being excluded from someone else's meeting is not the end of it. A person who is not invited, or who cannot attend, "may request a separate meeting with FDA to discuss the same matter or an additional matter."

What a meeting is worth

Before reading anything into a meeting, it is worth knowing what the regulation says it is not.

"Action on meetings and correspondence does not constitute final administrative action subject to judicial review" under the court review section.

So a meeting outcome is not a decision that can be appealed. It is a conversation with a paper trail, and the paper trail is the part that lasts.

The Commissioner may also decide that an open public meeting on a matter, or a class of matters, is in the public interest. Those are informal: the time, place and subjects are announced, and anyone may attend and take part without giving prior notice unless the announcement says otherwise.

Agency staff can be invited to outside meetings too, and are not obliged to go. They may ask that a meeting be opened where that serves the public interest, and may decline a private one on the same reasoning.

One kind of invitation must be refused. "An agency representative may not knowingly participate in a meeting that is closed on the basis of gender, race, or religion."

The documentation rule, and the discretion inside it

A transcript, recording or summarizing memorandum is prepared by an agency representative "when the agency determines that such documentation will be useful."

That is a judgment call, which means not every meeting leaves a summary written by the agency.

What is not discretionary is filing. The agency promptly files memoranda of meetings prepared by its representatives, and all correspondence relating to a pending matter, in the appropriate administrative file.

That duty explicitly includes "any written summary of a meeting from a participant". So a company's own account of a meeting, sent in writing, becomes part of the file.

For anyone trying to reconstruct what happened, that is the practical route. The participant's summary may exist even where an agency memorandum does not.

What has to be in the file

A separate section governs documentation of significant decisions, and it applies whether a matter arrived formally by petition or informally by correspondence.

The file must contain appropriate documentation of the basis for the decision, including evaluations, reviews, memoranda, letters, consultant opinions, meeting minutes and other pertinent written documents.

It must also contain the recommendations and decisions of individual employees, including supervisors. And there is a requirement about what those must show.

"The recommendations and decisions are to reveal significant controversies or differences of opinion and their resolution."

Disagreement inside the agency is meant to be visible in the file rather than smoothed out of it. An employee working on a matter may also record individual views in a written memorandum placed in the file.

Six rules for a document in the file

Any written document placed in an administrative file has to satisfy six conditions, and they read like a records policy anyone could borrow.

It has to relate to the factual, scientific, legal or related issues under consideration. It has to be dated and signed by the author.

It has to be directed to the file, to appropriate supervisors and other appropriate employees, and show everyone who received a copy.

It has to "Avoid defamatory language, intemperate remarks, undocumented charges, or irrelevant matters", with personnel complaints given as the example.

If it records another employee's views, analyses, recommendations or decisions, it has to be given to that employee.

And once completed, meaning typed in final form, dated and signed, it must "not be altered or removed. Later additions to or revisions of the document must be made in a new document."

The sentence that makes the file the only reality

One short paragraph decides how much weight anything outside the file can carry.

"Memoranda or other documents that are prepared by agency employees and are not in the administrative file have no status or effect."

That is a strong statement, and it pairs with the internal review rule. Review of a decision "must be based on the information in the administrative file."

If an interested person brings new information not in the file, the matter goes back to the appropriate lower level in the agency for reevaluation on that new information.

Which explains a pattern people find frustrating. Bringing new evidence to a senior official does not produce a senior decision on it; it sends the question back down.

Asking for a decision to be reviewed internally

A decision by any agency employee other than the Commissioner is subject to review by that employee's supervisor in four situations.

At the employee's own request. On the supervisor's initiative. As required by delegations of authority. And, the one that matters to outsiders, "At the request of an interested person outside the agency."

Review normally follows established supervisory channels, by consultation, by reviewing the file, or both.

Personal review by a center director or the Commissioner's office happens for four listed purposes. The first is "To resolve an issue that cannot be resolved at lower levels within the agency", including disputes between agency components or between the agency and an outside person.

The others are policy matters needing management attention, unusual situations requiring immediate review in the public interest, and where delegations require it.

There is also a scientific route. A sponsor, applicant or manufacturer of a drug or device may request review of a scientific controversy by an advisory panel or committee. A denial has to be briefly explained in writing to the requester. A denial can itself be taken to the agency's mediator and ombudsman.

The weekly public calendar

A separate section requires a public calendar, published each week, showing significant events of the previous week involving named senior officials.

Three categories are listed. Significant meetings with members of the judiciary, members of Congress or congressional committee staff, where the meeting relates to a pending case, hearing or other regulatory action or decision.

Significant meetings, conferences, seminars and speeches. And, listed on its own: "Social events sponsored by the regulated industry."

Exclusions are stated too. Meetings that would prejudice law enforcement, meetings that would invade privacy, meetings with the press, and meetings with onsite contractors.

Each entry gives the date, the people and the subject, and where many attended, individual names are not required. "When more than one FDA representative is in attendance, the most senior agency official will report the meeting on the public calendar."

Six roles are covered: the Commissioner, senior associate commissioners, deputy commissioners, the associate commissioner for regulatory affairs, center directors and the chief counsel.

When private contact becomes prohibited

Everything above describes the ordinary state of affairs. It changes once a formal evidentiary hearing or a public board of inquiry is announced.

Before that notice, an interested person may meet or correspond with agency representatives under the ordinary meeting rules. After publication, separation of functions applies.

The center handling the matter becomes a party. Its representatives may not participate or advise in any decision except as witness or counsel in public proceedings, and other communication with the Commissioner's office about the matter stops until the decision.

Designations that cross that line have to be in writing and filed. The same structure applies to agency lawyers, with a memorandum filed and made part of the administrative record.

For outsiders, the rule is absolute. "No person outside the agency may have an ex parte communication with the presiding officer or any person representing the office of the Commissioner concerning the matter in the hearing." The prohibition runs in both directions.

It also binds early. Anyone who knows of a hearing notice before it is published is bound from the moment they know.

What happens if someone breaks it

The regulation does not treat a prohibited contact as something to be dealt with quietly.

A written communication contrary to the rule is immediately served on all other participants and filed, by whoever received it. An oral one "must be immediately recorded in a written memorandum" and served and filed the same way.

The person involved in a prohibited oral communication must, if possible, be made available for cross-examination during the hearing about what was said. Rebuttal testimony is permitted, and both are transcribed and filed.

And there is a consequence with teeth. The consequence is set out in the rule itself. Making such a communication "may, consistent with the interests of justice and the policy of the underlying statute, result in a decision adverse to the person". The sentence ends "knowingly making or causing the making of such a communication."

One channel stays open. A participant may send a written communication about a settlement proposal to the Commissioner's office, in the form of a pleading, served on all participants and filed like any other.

Settlement talk, and what it cannot be used for

A short section allows anyone to propose settlement at any time in a proceeding, and requires participants to have an opportunity to consider it.

The protection attached is the useful part. "Unaccepted proposals of settlement and related matters", with proposed stipulations that were not agreed given as the example, are not admissible in evidence in an agency administrative proceeding.

The agency also commits to opposing the admission of settlement information in a court proceeding or another administrative proceeding.

That is a familiar principle, written into the agency's own practice rules rather than left to general law.

How to read this against a company's account of events

Three tests come out of these sections and can be applied to almost any claim about agency contact.

First, a meeting is not a decision, and the regulation says so. Nothing said in one is reviewable, and no outcome is final action.

Second, if it is not in the administrative file it has no status or effect. That applies to internal agency memoranda by its own terms, and it tells a reader where the durable record sits.

Third, senior contact is partly public. Significant meetings involving the named senior officials, including industry-sponsored social events, are supposed to appear on a weekly public calendar.

One limit on this article. Only these six sections of part 10 were read in full. The formal hearing procedures they cross-reference, the advisory committee rules, and the internal staff manual procedures were not examined.

Nothing here describes any particular meeting or company. It describes the rules that would govern one.

Sources

Each document below is named as it names itself, with the date printed on that document rather than the day it was read.

1. Title 21 Code of Federal Regulations section 10.65, Meetings and correspondence, read in full for the right to request a private meeting, attendance control, open public meetings, outside invitations and the filing duty — Electronic Code of Federal Regulations, Office of the Federal Register, January 2001
2. Title 21 Code of Federal Regulations section 10.70, Documentation of significant decisions in administrative file, read in full for the contents of the file, the six document rules and the no-status provision — Electronic Code of Federal Regulations, Office of the Federal Register, April 1979
3. Title 21 Code of Federal Regulations section 10.75, Internal agency review of decisions, read in full for the four review triggers, the four purposes of senior review, the file-only rule and the scientific controversy route — Electronic Code of Federal Regulations, Office of the Federal Register, July 2019
4. Title 21 Code of Federal Regulations section 10.100, Public calendar, read in full for the three included categories, the four exclusions, the entry contents and the six covered roles — Electronic Code of Federal Regulations, Office of the Federal Register, January 2001
5. Title 21 Code of Federal Regulations section 10.55, Separation of functions; ex parte communications, read in full for the trigger, the internal separation, the outside prohibition, the handling of a breach and the settlement channel — Electronic Code of Federal Regulations, Office of the Federal Register, January 1999
6. Title 21 Code of Federal Regulations section 10.110, Settlement proposals, read in full — Electronic Code of Federal Regulations, Office of the Federal Register, April 1979