What the FDA will and will not release about a company

The default is disclosure

Part 20 of title 21 is headed Public Information, and it governs what the FDA does when somebody asks for a record.

The policy section states the aim first. FDA "will make the fullest possible disclosure of records to the public." That is qualified by privacy rights, by property rights in trade secrets and confidential commercial information, and by the agency's need "to promote frank internal policy deliberations and to pursue its regulatory activities without disruption."

Then it sets the operating rule. "Except where specifically exempt pursuant to the provisions of this part, all FDA records shall be made available for public disclosure."

Withholding is narrowed to two situations. The agency will withhold "only if" it "reasonably foresees that disclosure would harm an interest protected by an exemption described in this part," or "Disclosure is prohibited by law."

You do not have to explain why you want it

This is the part most people do not know, and it is written into the same section.

Nonexempt records "shall be made available for public disclosure upon request regardless of whether any justification or need for such records have been shown."

There is one narrow situation where a purpose statement can be asked for, and it is about privacy rather than about vetting the requester. It applies where the record sits in a Privacy Act record system, the requester is not the person the record is about, and the disclosure is discretionary rather than required.

The section also defines what counts, broadly. A record includes "any information that would be an Agency record subject to the requirements of this part when maintained by the Agency in any format, including an electronic format."

A document is not all-or-nothing

Section 20.22 handles the common case where one file contains both kinds of material.

The rule is that the nondisclosable part is deleted and the rest is released. That fails only where the two "are so inextricably intertwined that it is not feasible to separate them," or where releasing the disclosable part "would compromise or impinge upon the nondisclosable portion."

It also requires the redaction to be visible. Where information is deleted, "the amount of information deleted shall be indicated on the portion of the record that is made available," unless indicating it would itself cause the harm an exemption protects against.

And the marking has to be specific. "When technically feasible, the amount of information deleted shall be indicated at the place in the record where the deletion is made." And "The exemption(s) under which the information has been deleted shall be noted at the site of the deletion."

That is why a released FDA document arrives with labeled blocks rather than a silent gap. The label tells a reader which category was invoked.

The eight exemptions, by name

Subpart D of part 20 holds the exemptions. Section 20.60 states that they apply, and the seven that follow name the categories.

Section 20.61 covers trade secrets and commercial or financial information which is privileged or confidential. Section 20.62 covers inter- or intra-agency memoranda or letters. Section 20.63 covers personnel, medical, and similar files, disclosure of which constitutes a clearly unwarranted invasion of personal privacy.

Section 20.64 covers records or information compiled for law enforcement purposes. Section 20.65 covers national defense and foreign policy. Section 20.66 covers internal personnel rules and practices. Section 20.67 covers records exempted by other statutes.

Two of those carry a definition worth knowing. A trade secret "may consist of any commercially valuable plan, formula, process, or device that is used for the making, preparing, compounding, or processing of trade commodities." It must also "be said to be the end product of either innovation or substantial effort." And there "must be a direct relationship between the trade secret and the productive process."

Confidential commercial information is defined separately as "valuable data or information which is used in one's business." It must also be "of a type customarily held in strict confidence or regarded as privileged and not disclosed to any member of the public by the person to whom it belongs."

The deliberative exemption has an expiry date

Section 20.62 is the one that covers internal agency discussion, and it is the reason a file can come back with the analysis removed and the facts left in.

It allows withholding of memoranda "that would not be available by law to a party other than an agency in litigation." Then it carves the facts back out, "except that factual information that is reasonably segregable in accordance with the rule established in § 20.22 is available for public disclosure."

It also has a hard time limit, which is unusual. "The deliberative process privilege shall not apply to records created 25 years or more before the date on which the records were requested."

Enforcement files open when the matter closes

Section 20.64 is the exemption most likely to be in play when somebody asks about a company under investigation, and it is written around a clock rather than a permanent seal.

Its grounds are familiar. They cover disclosure that "Could reasonably be expected to interfere with enforcement proceedings," would deprive a person of a fair trial, could reveal a confidential source, or could endanger a life.

The timing rule is the important part. No such record is available "prior to the consideration of regulatory enforcement action based upon that record's being closed."

And after that: "After the consideration of regulatory enforcement action is closed, such records shall be made available for public disclosure except to the extent that other exemptions from disclosure in this subpart are applicable."

The section defines closed for both administrative and court action, including where "a final decision has been made not to take such action" or where the matter and all related appeals have concluded. There is one permanent exception: "No statements of witnesses obtained through promises of confidentiality are available for public disclosure."

Two ways an exemption stops working

Subpart E is titled Limitations on Exemptions, and it holds the reason an exempt-looking record can still be released.

The first is prior disclosure. Under section 20.81, an otherwise exempt record "is available for public disclosure to the extent that it contains data or information that have previously been disclosed in a lawful manner."

That has careful edges. Disclosure to an employee, a consultant, or under a commercial arrangement with secrecy safeguards does not count, and neither does disclosure to clinical investigators or institutional review board members made with appropriate safeguards.

The second is discretion. Section 20.82 lets the Commissioner disclose part or all of an otherwise exempt record. The condition is that doing so "is in the public interest, will promote the objectives of the Freedom of Information Act and the Agency."

That discretion has four hard stops. It does not reach records exempt under section 20.61 for trade secrets and confidential commercial information. Nor records exempt under section 20.63 for personal privacy, records prohibited from disclosure by statute, or Privacy Act records where release would be a clearly unwarranted invasion of privacy.

And a discretionary release does not become a rule. It obliges the agency to give the same record to anyone else who asks, but "shall not set a precedent for discretionary disclosure of any similar or related record."

What this changes for a reader of this market

Three things follow, and each is checkable rather than atmospheric.

An absence of public documents about a company is not evidence of a clean file. Under section 20.64 an open enforcement matter is exempt until it closes, so the quiet period and the nothing-to-see period look identical from outside.

A trade secret claim over a formula is contemplated by the rules, not a dodge. The definition in section 20.61 is written around exactly that: a formula or process used in making, preparing, compounding or processing, tied directly to the productive process.

A released document with labeled redactions is a more informative document than it looks. Section 20.22 requires the exemption to be noted at the site of the deletion, so the marks say which category was claimed.

This page describes how the rules read. It does not describe any company's file, does not name any 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 20.20, Policy on disclosure of Food and Drug Administration records — Electronic Code of Federal Regulations, Office of the Federal Register, September 2022
2. Title 21 Code of Federal Regulations section 20.22, Partial disclosure of records — Electronic Code of Federal Regulations, Office of the Federal Register, September 2022
3. Title 21 Code of Federal Regulations section 20.61, Trade secrets and commercial or financial information which is privileged or confidential — Electronic Code of Federal Regulations, Office of the Federal Register, September 2022
4. Title 21 Code of Federal Regulations section 20.62, Inter- or intra-agency memoranda or letters — Electronic Code of Federal Regulations, Office of the Federal Register, September 2022
5. Title 21 Code of Federal Regulations section 20.64, Records or information compiled for law enforcement purposes — Electronic Code of Federal Regulations, Office of the Federal Register, January 1994
6. Title 21 Code of Federal Regulations section 20.81, Data and information previously disclosed to the public — Electronic Code of Federal Regulations, Office of the Federal Register, May 2003
7. Title 21 Code of Federal Regulations section 20.82, Discretionary disclosure by the Commissioner — Electronic Code of Federal Regulations, Office of the Federal Register, September 2022