The file types FDA has already written a disclosure rule for

A table that settles questions in advance

Subpart F of 21 CFR part 20 is headed Availability of Specific Categories of Records. Its opening section explains what the whole subpart is for.

The provisions there, and the ones it cross-references, "state the way in which specific categories of Food and Drug Administration records are handled upon a request for public disclosure."

The exemptions still apply on top. A record ordinarily available "is not available for such disclosure to the extent that it falls within an exemption," subject to the limits on those exemptions.

What makes this subpart useful to somebody outside the agency has little to do with filing a request. It is a published list of the document types the drug system actually generates.

What the cross-reference list contains

Paragraph (c) of section 20.100 is a numbered list of regulations elsewhere in title 21 that each settle the status of one document category. The numbering runs up to item (48), and items (20) through (22) are marked Reserved.

Several entries name documents that come up constantly in this market. Drug establishment registrations and drug listings are settled at section 207.81. Investigational new drug notices are settled at section 312.130. New drug application files are settled at section 314.430.

Others map the surrounding territory. Food additive petitions, color additive petitions, cosmetic establishment registrations, cosmetic product ingredient statements and cosmetic product experience reports each have their own entry.

So do device documents, including premarket notification submissions, premarket approval applications, investigational device exemptions and reports of certain adverse experiences with a medical device.

And so do two entries about failure. Disqualification determinations for an institutional review board and for a nonclinical laboratory are each listed with their own governing section.

Inspection paperwork: the split that explains the silence

Section 20.101 covers administrative enforcement records, and it draws a line that explains why some documents are easy to find and others are not.

Records "disclosed to any member of the public, including the person who is the subject of such action, are available for public disclosure." The timing is "at the time such disclosure is first made." The section names examples: correspondence following a factory inspection, recall or detention requests, notice of refusal of admission of an imported product, regulatory letters and inspection forms furnished to companies.

The other half is different. Records relating to administrative enforcement action "that are not disclosed to any member of the public constitute investigatory records" subject to the law enforcement rules.

The example it gives is the one that matters most. "an establishment inspection report is an investigatory record" subject to those rules, except where the Commissioner exercises discretion to release it.

That is the mechanism behind a familiar asymmetry. The letter sent to a company can be public while the inspector's underlying report is not.

Correspondence is public when it is sent

Section 20.103 is short and broad.

Correspondence to and from members of the public, members of Congress, "organization or company officials, or other persons," is available for public disclosure. Members of the Executive Branch and special government employees are excepted.

The timing is immediate by default. Such correspondence "is available for public disclosure at the time that it is sent or received," unless another rule in part 20 sets a different time.

The split inside voluntarily submitted data

Section 20.111 is the most detailed section in the subpart, and it applies only to data submitted voluntarily rather than as part of a required filing.

It has a trap in its first paragraph. Data that may be required but is submitted voluntarily instead is not covered, and "will be handled as if they had been required to be submitted."

The disclosable list is the interesting half. Available unless extraordinary circumstances are shown are "All safety, effectiveness, and functionality data and information for a marketed ingredient or product," with one named exception for over-the-counter drug review data.

Also disclosable: "A protocol for a test or study," unless it falls within the trade secret exemption. Also an assay method or other analytical method, unless it serves no regulatory or compliance purpose and falls within that exemption.

And a list of ingredients. For a drug, that means "a list of all active ingredients and any inactive ingredients previously disclosed to the public," which is a narrower thing than a full formula.

What stays out, and why marketed is the hinge

Paragraph (d) of the same section lists what is not available, and reading it beside paragraph (c) shows what the whole section turns on.

Not available are "All safety, effectiveness, and functionality data and information for a developmental ingredient or product that has not previously been disclosed to the public."

Also not available: "Manufacturing methods or processes, including quality control procedures." Also "Production, sales, distribution, and similar data and information," except in aggregate form that reveals nothing protected. Also "Quantitative or semiquantitative formulas."

The hinge is the word marketed. Safety and effectiveness data for something on the market is disclosable. The same kind of data for something still in development is not, unless it has already been made public or the product was abandoned and no longer represents a trade secret.

The section also defines its own key term broadly. Safety, effectiveness and functionality data "include all studies and tests of an ingredient or a product on animals and humans." They also include tests "for identity, stability, purity, potency, bioavailability, performance, and usefulness."

Harm reports and who gets anonymized

Paragraph (c)(3) of section 20.111 handles adverse reaction reports, product experience reports and consumer complaints, and the redaction depends on who filed.

A report from a consumer or user is released "after deletion of names and other information that would identify the person submitting the information."

A report from the manufacturer is released after deleting the patient's identity and any third party such as a physician or hospital. One more deletion is worth noticing: "Names and any other information that would identify the manufacturer or the brand designation of the product, but not the type of product or its ingredients."

So a manufacturer-filed report can reach the public with the brand removed and the substance kept. Section 20.112 routes voluntary reports from physicians and hospitals through the same machinery, and section 20.113 handles voluntary product defect reports on similar lines.

There is a firm limit on individual cases. A request for a record relating to a specific individual or incident "will be denied unless accompanied by the written consent" of two people: the one who submitted the report and the one it concerns. The subject can obtain it on request.

What a reader can use this for

The subpart is written for people making requests, but its most useful function here is as a map.

It tells you which artifacts exist. Establishment registrations, listings, investigational notices, application files, inspection correspondence, disqualification determinations and defect reports are all named document types with defined statuses.

It tells you why some of them are hard to see. An establishment inspection report is treated as an investigatory record, so its absence from public view is the expected state rather than an anomaly.

And it tells you what a public harm report will and will not show. A manufacturer-filed report reaches the public without the brand name attached, which is a real limit on what any tally of public reports can prove about one seller.

This page describes the rules as written. It makes no claim about any company's file, names no seller, and is not legal advice.

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 20.100, Applicability; cross-reference to other regulations — Electronic Code of Federal Regulations, Office of the Federal Register, September 2022
2. Title 21 Code of Federal Regulations section 20.101, Administrative enforcement records — Electronic Code of Federal Regulations, Office of the Federal Register, March 1977
3. Title 21 Code of Federal Regulations section 20.111, Data and information submitted voluntarily to the Food and Drug Administration — Electronic Code of Federal Regulations, Office of the Federal Register, May 2003
4. Title 21 Code of Federal Regulations section 20.116, Drug and device registration and listing information — Electronic Code of Federal Regulations, Office of the Federal Register, August 2016
5. Title 21 Code of Federal Regulations section 20.117, New drug information — Electronic Code of Federal Regulations, Office of the Federal Register, January 1999