Do Not Otherwise Promote an Investigational Drug

AI-verifiedblockerBinding lawRaised as a question — a person decides

Rule

Beyond specific safety/effectiveness claims, a sponsor or investigator (or anyone acting on their behalf) may not otherwise promote an investigational new drug, i.e., commercialize it before approval.

Check

Review the piece for promotional hallmarks applied to an unapproved drug/use — persuasive tone, calls to prescribe or use, branding/marketing emphasis, favorable positioning versus competitors — that go beyond neutral scientific exchange. Flag if the piece functions to market the unapproved drug.

Escalate when

It is unclear whether a communication (e.g., a disease-awareness piece, investor communication, or conference presentation) crosses the line from scientific exchange into promotion of the investigational drug; escalate to MLR/legal for a context-specific determination.

Where this comes from

21 CFR 312.7(a). The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.

… § 312.7 Promotion of investigational drugs. (a) Promotion of an investigational new drug. A sponsor or investigator, or any person acting on behalf of a sponsor or investigator, shall not represent in a promotional context that an investigational new drug is safe or effective for the purposes for which it is under investigation or otherwise promote the drug. This provision is not intended to restrict the full exchange of scientific information concerning the drug, including dissemination of scientific findings in scientific or lay media. Rather, its intent is to restrict promotional claims of safety or effectiveness of the drug for a use for which it is under investigation and to preclude commercialization of the drug before it is approved for commercial distribution. …

Open the original at these words on ecfr.gov ↗Read our full copy →

Document: 21 CFR 312.7
Version: 2026-09-16 — the link above is pinned to this date, so it shows the text as it stood then
Retrieved: 2026-09-21 from www.ecfr.gov
Fingerprint: fda613253bfbb24458871266…

Applies when

Launch stagepre-approval

How this rule was checked

Citation proven by script and passed an independent verifier running on a different model. Not yet confirmed by a human.

Drafted
claude-sonnet-5 · 2026-09-21
Independent verification — pass
claude-opus-5 · 2026-09-21
Reviewer's reasons
- Supported: the quoted phrase sits in the operative prohibition of § 312.7(a) — 'shall not represent in a promotional context ... or otherwise promote the drug' — not in an example, definition, or preamble. The 'otherwise promote' clause is an independent prohibition beyond safety/effectiveness representations, which is exactly what the rule states.
- Not overstated: 'shall not' is mandatory, so framing as 'may not' is correct; the rule keeps the regulation's actor scope (sponsor, investigator, or any person acting on their behalf); and the gloss 'i.e., commercialize it before approval' tracks the source's own statement of intent ('to preclude commercialization of the drug before it is approved for commercial distribution') rather than inflating it.
- The source's carve-out ('not intended to restrict the full exchange of scientific information ... including dissemination of scientific findings in scientific or lay media') is preserved in the check ('go beyond neutral scientific exchange') and reinforced by the escalation clause, so the rule does not sweep in protected scientific communication.
- Atomic: one obligation — do not otherwise promote an investigational drug. The listed promotional hallmarks are indicia for applying that single test, not separate independently checkable requirements. The explicit 'beyond specific safety/effectiveness claims' framing correctly leaves the first half of § 312.7(a) to a separate rule.
- Determinism 'judgment' is right: whether material 'promotes' or is a 'promotional context' turns on tone, positioning and overall impression, not on presence/absence of any literal string.
- Authority 'binding' is right — this is a codified federal regulation (21 CFR), and the locator 312.7(a) matches the subsection containing the quote.
- applies_when limited to pre-approval launch stage is justified: the prohibition attaches to an 'investigational new drug', i.e., before approval for commercial distribution. Severity 'blocker' is defensible given this is a statutory-level prohibition whose violation can jeopardize the IND.

Nearby rules

US-PRE-001 US-SCI-001