How a guidance document is made, and how to push back

What counts as guidance, and what is deliberately excluded

A guidance document is one prepared for agency staff, applicants and sponsors, and the public, that describes "the agency's interpretation of or policy on a regulatory issue."

The subjects are broad: design, production, labeling, promotion, manufacturing and testing of regulated products, the processing, content and evaluation of submissions, and inspection and enforcement policies.

The exclusion list is where this gets interesting for a reader. Guidance documents do not include "Documents relating to internal FDA procedures, agency reports, general information documents provided to consumers or health professionals". The list runs on: "speeches, journal articles and editorials, media interviews, press materials, warning letters, memoranda of understanding". Communications directed to individual persons or firms are excluded too.

That list is worth reading twice, because it names things people routinely treat as agency policy.

A speech is not guidance. A press statement is not guidance. A letter to one company is not guidance, and neither is a consumer information page.

The rule that stops policy arriving by press release

The exclusion list would be a loophole if the agency could simply announce policy through the excluded channels. One paragraph closes it.

The paragraph reads in part: "The agency may not use documents or other means of communication that are excluded from the definition of guidance document". The thing they may not be used for is "to informally communicate new or different regulatory expectations to a broad public audience for the first time."

And the trigger is stated in the same place. These practices must be followed whenever regulatory expectations that are not readily apparent from the statute or regulations are first communicated to a broad public audience.

So the test is not the format. It is whether a new expectation, not obvious from the law itself, is reaching a broad audience for the first time.

For someone tracking a shifting policy area, that gives a question to ask about any announcement: is this new, and did it arrive through a guidance document.

Two levels, and why the difference matters

Guidance is sorted into two levels, and the level decides whether the public gets to comment before it takes effect.

The first level covers documents that "Set forth initial interpretations of statutory or regulatory requirements". It also covers documents that "Set forth changes in interpretation or policy that are of more than a minor nature". And documents that include complex scientific issues, or that "Cover highly controversial issues."

The second level is defined by subtraction. It covers documents setting out existing practices or minor changes, and it includes every guidance document not classified in the first level.

The regulation also defines its own second person: the term refers to all affected parties outside the agency. Reading the section, the word you means anybody outside.

Level assignment is therefore the single most consequential judgment made about a guidance document, and it is made by the agency.

The full procedure, and the exception that skips it

For a first-level document the ordinary path has four stages.

Before drafting, the agency can seek or accept early input from outside individuals or groups, for example through public meetings and workshops.

After drafting, it publishes a Federal Register notice announcing the draft, posts it online and in hard copy, and invites comment. It may also hold meetings or send the draft to an advisory committee.

After the comment period it reviews comments, prepares a final version incorporating suggested changes where appropriate, publishes a notice, posts the document, and implements it. It may instead issue another draft and repeat the cycle.

The exception is short and important. The agency will not seek comment before implementing a first-level document "if the agency determines that prior public participation is not feasible or appropriate."

In that case the sequence inverts: notice, posting, "Immediately implement the guidance document", and invite comment afterwards. Comments received are reviewed and the document revised where appropriate.

Second-level guidance takes effect on posting

The second-level procedure is shorter still, and it explains why some policy appears without any announcement in the Federal Register.

The agency posts the document online and in hard copy, immediately implements it unless it says otherwise when the document is made available, and invites comment.

If comments arrive, they are reviewed and the document revised where appropriate, and a revised version goes online.

There is no requirement of a Federal Register notice for this level, and no comment period before it operates.

Against all of that sits a standing right. "You can comment on any guidance document at any time", and the agency will revise guidance in response to comments where appropriate.

Four ways an outsider can move the process

The participation paragraph is more generous than most people realize, and each route is separately stated.

The first is commenting on a document in development, through the procedures above.

The second is proposing a topic. "You can suggest areas for guidance document development." The suggestion should address why guidance is necessary.

The third is writing one. A person may submit a draft of a proposed guidance document for the agency to consider. It is marked as a guidance document submission and filed with the dockets staff or submitted electronically, and only one copy is needed.

The fourth runs the other way. "You can, at any time, suggest that FDA revise or withdraw an already existing guidance document", addressing why and, where applicable, how it should be revised.

There is also an annual signal to watch. Once a year the agency publishes, in the Federal Register and online, "a list of possible topics for future guidance document development or revision during the next year", and anyone may comment on that list.

If the agency agrees to draft or revise a document following one of these suggestions, the suggester can take part in developing it.

Seven things every guidance document must carry

The standard elements are a checklist a reader can run against any document claiming to be guidance.

It has to include the word guidance. It has to identify the issuing center or office. It has to identify the activity and the people it applies to.

It has to "Prominently display a statement of the document's nonbinding effect". It has to include the date of issuance.

It has to "Note if it is a revision to a previously issued guidance and identify the document that it replaces". And a draft has to say it is a draft.

Two of those are the ones that catch problems. A document with no nonbinding statement and no issuance date is not being handled as guidance, whatever it is called.

One narrow exemption exists. Draft guidance that is the product of international negotiations need not carry these elements, but any final document issued that way must.

The four words guidance may not use

A separate sentence forbids mandatory language in a guidance document.

It names four terms and rules them out, with a single exception: they are permitted "unless FDA is using these words to describe a statutory or regulatory requirement."

The words are the ordinary vocabulary of obligation. The point is that guidance may report an obligation that exists in law, but may not create the appearance of one.

That gives a reader a concrete test. Where a guidance document uses obligation language, the sentence should be traceable to a statute or regulation, not to the guidance itself.

The companion rule sits on the agency side. Guidance does not legally bind the agency, but it represents current thinking, so "FDA employees may depart from guidance documents only with appropriate justification and supervisory concurrence."

And on the outside, the corresponding freedom is written out: "You may choose to use an approach other than the one set forth in a guidance document." That alternative has to comply with the statutes and regulations, and the agency is willing to discuss it.

How to find out what exists

Two publication duties make the body of guidance findable rather than folkloric.

The agency maintains a current list of all guidance documents online, and "New documents will be added to this list within 30 days of issuance."

Once a year it publishes a comprehensive list in the Federal Register, identifying what has been added or withdrawn since the previous comprehensive list.

The lists carry the name of each document, its issuance and revision dates, and how to obtain copies.

That annual added-and-withdrawn comparison is the most useful artifact here. It is a year-over-year diff of the agency's stated positions, published on purpose.

The agency also reviews existing guidance periodically to decide whether it needs changing or withdrawing, and reviews relevant guidance when significant changes are made to a statute or regulation.

What to do when guidance is treated as a rule

The last paragraph of the section is a complaint procedure, and it names two distinct grievances.

One is that someone did not follow the procedures in the section. The other is "or that someone at FDA treated a guidance document as a binding requirement".

The route is a chain. Contact that person's supervisor in the issuing center or office. If unresolved, contact the next highest supervisor.

The center or office ombudsman can be contacted for assistance at any point in that.

And if the issue cannot be resolved at that level, or progress through the chain stalls, "you may ask the Office of the Chief Mediator and Ombudsman to become involved."

Two internal safeguards back that up. All current and new employees involved in developing, issuing or applying guidance are trained on these practices, and centers and offices monitor development and issuance to ensure the practices are followed.

Why this matters when reading claims about a product

Guidance is where a great deal of the policy affecting this market actually lives, and it is often described loosely.

This section supplies a few plain tests. Does the document carry a prominent nonbinding statement and an issuance date. Does it appear on the published list. Is its obligation language tied to a statute or regulation.

One more test applies to announcements rather than documents. A speech, a press statement or a letter to one firm is excluded from the definition, and cannot be the first place a new expectation reaches a broad audience.

And approval authority is stated: each center and office must have written procedures ensuring that issuance of all guidance documents is approved by appropriate senior officials.

One limit on this article. Only this section was read in full. The guidance documents themselves, the internal center procedures it requires, and the statute underneath it were not examined.

This describes how guidance is supposed to be produced and used. Whether any particular document met these requirements is a question about that document, and nothing here answers it.

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 10.115, Good guidance practices, read in full for the definition and exclusions, the anti-informal-announcement rule, the two levels, both development procedures, the four participation routes, the annual topic list, the seven standard elements, the mandatory-language prohibition, the publication duties and the complaint route — Electronic Code of Federal Regulations, Office of the Federal Register, March 2018