Section 3 of Chapter 4 creates a narrow, conditional exception to the general prohibition on providing information about unapproved or off-label uses of drugs. The entire provision turns on a single trigger: a request must originate from a healthcare professional, patient, or patient organization. The company's role is to respond — never to initiate.
01The Eight Conditions — All Must Be Met Simultaneously
All eight conditions must be satisfied at the same time. Partial compliance with seven of the eight does not engage the exception.
| Condition | What it requires |
|---|---|
| (1) Separation from regular activities | The inquiry response must be clearly distinguished from routine promotional sales information activities. The two must not be mixed in the same meeting or materials. |
| (2) Content and recipient limited to the request | The information provided must be limited to what was specifically asked. The recipient must be limited to the person who asked. Expanding beyond the question asked is not permitted. |
| (3) No fabrication of a request | A company must not provide information as if responding to a request when no genuine request was made. |
| (4) Accurate information based on scientific, objective evidence | The information must not be false or exaggerated. It must be grounded in scientific and objective evidence and provided accurately. Summarizing, omitting, or emphasizing selected elements is prohibited. |
| (5) Company-related research and papers must be properly managed | Any company-affiliated research or publications used must have been conducted in accordance with GCP regulations, the Clinical Trials Act, or equivalent standards. |
| (6) Negative information must be provided | Adverse effects, increased risks, and results that failed to demonstrate statistical significance must be included in the information provided. |
| (7) Explicitly state that the use is not approved | The company must clearly communicate that the indication, dosage, or administration being discussed has not received regulatory approval. |
| (8) Create and retain records | A record of how the inquiry arose, who received the information, and what was provided must be created and retained. |
So what (what it means): The eight conditions represent the minimum standard of integrity for this type of interaction — not a high bar, but the floor. Any missing condition exposes the activity to the interpretation that it was promotional activity in disguise.
So why (why it is written this way): Information about unapproved or off-label uses involves incomplete evidence by definition. Multiple conditions are required to prevent this exception from becoming a de facto pathway for off-label promotion, which could lead patients to receive treatments without adequate evidence of safety and efficacy.
02Condition (3): What "Fabricating a Request" Means in Practice
Condition (3) is easy to misread as obvious. In practice it addresses a common pattern: a representative arrives with off-label data and says "if you have any questions, I'm happy to answer them" — or a brochure is designed to prompt an inquiry. In both cases, the company has manufactured the conditions for a "request" and then "responded" to it. The form looks responsive; the substance is initiation.
So what (what it means): Only a question that arises spontaneously from the healthcare professional's own clinical need qualifies as a genuine request. A question that a company engineered — however subtle the engineering — is promotional activity, and the exception does not apply.
So why (why it is written this way): Manufacturing the appearance of an unsolicited inquiry is the classic technique for delivering promotional off-label information while claiming it was merely responsive. Substance, not form, determines whether the exception applies.
03Condition (4): Why Summarizing and Emphasizing Are Prohibited
Summarizing and emphasizing scientific information appear neutral but are powerful tools for steering a reader toward a particular conclusion. When something is left out of a study summary, or when one finding is presented more prominently than others, the resulting picture differs from the original data. Condition (4) closes this gap by requiring the information to be provided as-is, without editorial intervention.
So what (what it means): Providing information on unapproved uses should be as close as possible to transmitting the source material directly. The moment editorial judgment enters — selecting what to emphasize, what to abbreviate — the company's promotional intent begins to shape the information.
So why (why it is written this way): Information that has not passed regulatory review needs to be received in its entirety — including its limitations and failures. Presenting only the favorable elements is functionally equivalent to making a false claim about the incomplete evidence.
04Condition (8): The Function of the Record Requirement
The obligation to create and retain a record of every such inquiry response serves two functions. First, it enables after-the-fact verification that a genuine request existed and that the response stayed within the permitted scope. Second — and perhaps more practically important — it acts as a real-time brake on the activity itself. Knowing the interaction will be documented changes how it is conducted.
So what (what it means): Record-keeping is not paperwork after the fact — it is a behavioral control that shapes the interaction as it happens. "This will go on the record" is a significant filter on what gets said.
So why (why it is written this way): Without records, there is no way to verify that the exception was used appropriately rather than abused as a promotional channel. Records preserve the "exceptional" character of this exception and provide the foundation for regulatory review or internal audit when questions arise.