Approved answers for sales reps in seconds — quoted from the label, cited to the page, off-label sent to medical
Every rep question answered in seconds from approved words only, cited to the page.
See one case, screen by screen ↓A physician asks a question mid-call. The rep has the prescribing information, a portal of approved pieces with approval numbers and expiry dates, and a field policy that says what must never be discussed. Finding the right page, checking the piece is the current version and still in date, and quoting it without paraphrase takes minutes the call does not have.
The questions that fall outside the label are the risky ones. An unsolicited question about an unapproved use has to go to Medical Information in the physician’s own words; a patient’s experience on the drug has to reach Drug Safety within one business day. Under time pressure, reps paraphrase, answer from memory, or forget the report — and nobody sees which questions had no approved answer at all.
Estimated split for one rep in a month, in hours, by hand and with the desk.
Six specialist agents sort each question, quote the approved answer, guard the line and route the rest to medical or safety; the rep confirms each referral.
Sam Patel, a sales representative in Seattle, is in a call with Dr. Elena Ruiz, a dermatologist. Here is what the desk does with her questions, screen by screen, in the working solution — and how Dana Okafor, who owns the desk, decides on a question nothing approved answers yet.
Dana owns the desk for the immunology field team. Today 168 reps and account managers have asked 412 questions about Veltrimab and Corventa: 86% answered inside the line, 45 sent outside it — 38 to Medical Information, 7 to Drug Safety — and 13 with no approved answer, 3 of them waiting for her decision.
“Veltrimab label v7 is live — §5.4 wording changed · 3 saved answers re-quoted · 0 answers use v6 since Sep 30”
Sam types Dr. Ruiz’s question into the desk on the phone. The question classifier marks it on-label, storage and handling. The answer finder searches 186 approved items and finds 2 matches; label v7 is current. The answer composer quotes §16.2, page 11, word for word: up to 30 °C (86 °F) for a single period of up to 14 days, never back in the refrigerator.
Answered in 4 s · the approved line: 5 passed, 1 not needed.
For the patient, the desk offers the pen storage leave-behind, NWB-VEL-US-0441 v2: “Out of the fridge? Up to 14 days.” Sam shows it in the call, with the Important Safety Information on the page. It can also go to Dr. Ruiz as an approved email.
The classifier marks it an unapproved use. The finder returns the approved uses — plaque psoriasis and psoriatic arthritis, §1 — and the composer writes no answer. The boundary guard stops it at the line. Instead, the desk drafts a Medical Information request with Dr. Ruiz’s question in her own words and a choice of reply by email, letter or phone call.
“Hidradenitis suppurativa is not an approved use, so I can’t answer it — and it shouldn’t be discussed in the call.”
The request cannot be sent until Sam ticks “Dr. Ruiz asked this on her own — I did not prompt it”. Then it goes to Dr. Lena Ortiz’s queue in Medical Information as MIR-26-04417, with a reply due in 2 business days, and is logged to the 10:20 call record in the CRM.
“Dr. Lena Ortiz’s team will reply to Dr. Ruiz directly, usually within 2 business days. Please don’t follow up on the content.”
Dr. Ruiz mentions a patient who got shingles after the second dose. The desk does not advise on the patient’s care. It marks a possible adverse event, cites field policy FP-07 §4.2 — Drug Safety within one business day — and pre-fills the report: reporter, patient without a name, event, product, timing and outcome.
Nothing is sent until Sam confirms “These are the details as Dr. Ruiz told them”.
“Is there a free sharps container program for Veltrimab patients?” — asked by Jordan Lee for Dr. Anika Shah, and 14 times this month. The Medication Guide, page 3, covers how to dispose of used pens; nothing approved says whether a program exists. Dana chooses: request a new approved answer, point to an existing item, or send these to Medical Information.
Dana requests a new approved answer. The composer drafts it from the Medication Guide’s wording, every sentence keeping its source, and marks the one new claim — “does not run a program” — as needing brand confirmation. Approvers: Priya Raman for brand, and medical, legal and regulatory review, target Oct 21.
The decision goes on the question’s record: “New approved answer requested”, Dana Okafor, Oct 7 10:28. Until the answer is approved, reps who ask hear “an approved answer is on the way”, and the desk moves Dana on to the next question waiting.
Over the last 7 days: 2,184 questions from 351 reps, 85.5% answered inside the line, a median of 7 s from question to approved answer, 238 sent outside the line. A team-by-reason view shows why questions leave it — new hires ask about other conditions most.
“New hires ask about other conditions most — the desk’s answer ‘not an approved use’ doubles as training.”
The same desk, seen by the five people who run it — what their week looked like, and what it looks like now.
Six specialist agents sort each question, quote the approved answer, guard the line and route the rest to medical or safety; the rep confirms each referral.
Reads each rep question and decides what it is: on-label, unapproved use, possible adverse event, product complaint, comparison, access, or something with no approved answer.
Searches only the approved, in-date library — labels, Medication Guides and review-committee-approved items — and returns the passages with item, version, section and page.
Drafts the Medical Information request in the physician’s own words and, after the rep confirms it was unprompted, sends it and logs it to the CRM call.
Spots a possible adverse event or product complaint in the rep’s words, pre-fills the Drug Safety or Quality report and tracks the one-business-day clock.
Builds the rep’s answer from the approved words — quoted, with section and page — attaches safety information to efficacy answers, and offers the approved piece to show or email.
Checks every answer before the rep sees it: approved and current sources, no paraphrase, within approved uses, no comparisons, no advice on a patient’s care — and routes the rest.
Confirms each referral and safety report. The agents propose; a named person decides.
Dana can ask in plain words about what reps ask, what has no approved answer, requests to medical and the library — or tell it what to change.
Which questions have no approved answer?
Three are waiting for you: free sharps container program, asked 14 times; travelling by plane with the pen, 9; plan coverage in Oregon, 6. The Medication Guide already covers disposal — the open part is whether a program exists.
What did reps ask most this week?
2,184 questions in the last 7 days. Dosing & use 524, 97 % inside the line; safety 459, 93 %; efficacy 328, 88 %. The most-asked single question: how long the pen can stay out of the fridge — 23 times.
Add a rule: flag any question naming another company’s product for compliance review
Done — added to the approved line in Settings, switched on. The desk still gives the approved redirect; Omar Haddad gets a weekly list of the flagged questions. 6 of this week’s questions would have been flagged. Recorded in the audit trail.
Is anything still quoting the old label?
No. Veltrimab label v7 went live on Sep 30 and §5.4 changed wording. All 214 saved answers were re-checked that day: 3 were re-quoted from v7 and none uses v6. Retired items are invisible to the desk.
14 screens from the working solution, on its sample data. Pick one to see it large.
Where the line sits, where questions go when they leave it, and who decides — each one a setting, with the rules policy requires locked.
| Setting | Default | Choose from |
|---|---|---|
| Quote approved wording only | On · locked by compliance | Changed only by commercial compliance |
| Attach Important Safety Information to efficacy answers | On · locked by compliance | Changed only by commercial compliance |
| Stop comparisons unless an approved item makes them | On | On / Off |
| Unapproved use, asked unprompted | Medical Information — US · 2 business days | Medical Information — US · 2 business days / Medical science liaison for the territory |
| Possible adverse event | Drug Safety intake · 1 business day | Drug Safety intake · 1 business day / Drug Safety intake · same day |
| No approved answer — who decides | Dana Okafor · Field excellence | Dana Okafor · Field excellence / Priya Raman · Brand |
| Who approves new answers | Priya Raman + review committee | Priya Raman + review committee / Review committee only |
| Tell reps when an approved item they use is about to expire | Off | On — a heads-up from 60 days before the date / Off |
Every figure is labelled: a target the solution is built to, an estimate, a typical published result, or a proven one.
“demo” = seen in the working solution, on its sample products, labels and questions · “target” = the design goal, measured in the live solution · “estimated” = our estimate · Context: FDA guidance on unsolicited off-label requests · 21 CFR 202.1 (fair balance) · 21 CFR 314.80 (safety reporting). Veltrimab and Corventa are sample products. People, companies and products named on this page are fictional — characters and sample data in the working solution.
A desk sales reps and account managers ask product questions in the field app or CRM, mid-call. It answers only from the prescribing information, Medication Guides and review-committee-approved materials, quoted with section and page, and sends questions outside the label to Medical Information or Drug Safety.
It never answers them. It quotes the approved uses, then drafts a Medical Information request with the physician’s question in their own words. The rep must confirm the physician asked unprompted before it is sent, and Medical Information replies to the physician directly.
No. Answers quote the approved wording with item, version, section and page. The answer finder searches only approved, in-date items — no web or general knowledge — and if nothing answers the question, it says so.
When a rep describes a patient’s experience on the product, the safety catcher marks a possible adverse event, gives no advice on the patient’s care, and pre-fills the Drug Safety report without the patient’s name. The rep confirms the details and sends it; the one-business-day clock is tracked.
Saved answers are re-checked when the label changes. In the working solution, when Veltrimab label v7 went live, all 214 saved answers were re-checked the same day: 3 were re-quoted from v7 and none still uses v6. Expired and retired items are never quoted.
They wait for the desk owner with how often they were asked. The owner can request a new approved answer — drafted from approved wording for the review committee — point to an existing approved item, or send future asks to Medical Information. The decision is recorded with their name.
Yes. A rep confirms every referral and safety report before it leaves the line, the desk owner decides on every gap, new answers are approved by brand and the review committee, and rules required by field policy can be changed only by compliance.
The Agentic Solution Engine builds and deploys it from your requirements and documents — your prescribing information, approved materials, field policy and routing rules — and it goes live once every quality gate has passed. We will walk you through it on your own label first.
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