Industry · Pharma

AI messaging governance for medical, MLR, and commercial teams

On-label claims, MLR-aligned messaging, and adverse-event flagging on every AI-generated medical and commercial communication.

$3B+

in DOJ off-label promotion settlements over the past decade

DOJ

PhRMA Code

governs every interaction with HCPs, including AI-drafted materials

PhRMA

15 days

to report a serious adverse event - AI-surfaced AE signals must route immediately

FDA 21 CFR 314.80

The governance gap

AI doesn't know what's on label. It needs to be told.

LLMs cheerfully extend indications, dosing, and populations - language that maps directly to False Claims Act and DOJ off-label exposure. MLR review wasn't built for the volume AI now generates.

Message.inc enforces on-label claims, routes everything HCP- or patient-facing through MLR, and runs an adverse-event classifier on any AI processing of patient or HCP text.

1

Off-label drift in commercial copy

AI happily extends indications, populations, and dosing in ways that map directly to False Claims Act exposure.

2

MLR bottleneck breakage

Teams routing around Medical-Legal-Regulatory review with AI shortcuts create unreviewed assets with the company's name on them.

3

Missed adverse events

AI processing HCP or patient messages without an AE detection step turns reportable signals into invisible ones.

4

Fair-balance and ISI handling

Important Safety Information must travel with every claim. AI drafts routinely omit, summarize, or de-emphasize it.

Pre-built policy pack

On-label, MLR-aligned policies for every AI output

Pre-built rules covering label adherence, fair balance, PV signal routing, and full MLR auditability - applied across medical, commercial, and field teams.

  • LABEL-01
    On-label claim enforcement
    AI-generated commercial copy is checked against the approved label. Off-label language is blocked, not warned.
  • MLR-01
    MLR routing required
    All HCP- and patient-facing AI drafts route through MLR with full prompt, output, and reviewer trail.
  • AE-01
    Adverse event detection
    Any AI processing of HCP or patient text runs an AE classifier and routes positives to PV within 24 hours.
  • ISI-01
    Fair balance enforcement
    ISI and indication statements must appear with every promotional claim. Drafts without them are blocked.

Where Message.inc sits

Where Message.inc fits in pharma workflows

Field medical and MSL response letters
Sales aids, IVAs, and rep training
HCP and patient web content
Congress materials and posters
Internal product training and SOPs

Get governance live before the next OPDP letter

OPDP enforcement is back to pre-pandemic cadence and the surface area now includes every AI tool your reps and MSLs use. Close the gap before it becomes a warning letter.

We're onboarding a small cohort of pharma early adopters. Get early access and we'll reach out within a few days.

Early access

No credit card. Enterprise-ready terms.

Sources & further reading