DTC ad review that measures the major statement before a reviewer watches the cut
Every TV, streaming and social cut measured for how it presents risk, before a reviewer watches it.
See one case, screen by screen ↓A :60 lands from the agency with an air date and a media flight already bought. Before it can air, someone has to watch it frame by frame and ask the questions FDA asked in the September 2025 letters: are the visuals busy while the major statement is read, is the risk super on screen for all of it, can anyone read it, is the voice-over faster than the benefit part, does the music rise, does the montage promise more than the label.
Most of that is measuring by eye, with a stopwatch and a screenshot. The comments go back to the agency as notes without numbers, the next cut fixes half of them, and the round starts again. The streaming cut and the :15 social cutdown are made from the same master and repeat the same problems, while the air date stays where it is.
Estimated split for a :60 national TV cut that goes back to the agency once, by hand and with the solution.
Six specialist agents frame, align, measure and match every cut, then write the revisions and the filing; the regulatory lead decides each finding.
Harborline Health uploads cut v4 of “Back to the everyday”, the Veltrimab :60 national TV spot for plaque psoriasis, airing Oct 26 on a $4.2M flight. Here is what happens next, screen by screen, in the working solution.
Priya opens the on-air board: 8 creatives airing in the next 30 days, 1 cleared and 3 at risk, 5 findings to decide and 4 new cuts not audited yet. The air schedule shows each brand’s TV, streaming, social, radio and web creatives against their air dates. At the top right sits the biggest flight not yet cleared: AD-611, 19 days to air, cut v4 arrived today at 07:52.
Enforcement watch: “recent FDA letters in the precedent library that look like our creatives.”
Before anyone presses play, the media framer has broken cut v4 into 21 shots, read 4 supers for size and contrast, and timed all 155 words of the voice-over. The timeline lays picture, voice-over, on-screen text and music side by side, with the major statement marked at 0:31–0:52.
The claim & risk aligner finds all 4 of the label’s most-serious risks spoken, but “liver problems” never shown, and a montage that implies more than the label. The risk presentation meter counts 6.7 shot changes per 10 seconds under the risks, risk text for 43% of the major statement, and risks read at 3.2 words a second against 2.2 for the benefit.
“The agents measure and propose. You decide every finding before anything goes to the agency.”
Two high and three medium, with 3 checks passed. The first: competing visuals during the major statement — 14 shots in 21 seconds, one every 1.5 s against one every 5.2 s in the benefit part, kayaking, mountain biking, beach volleyball, a wedding dance floor. Each finding carries its timestamp, the rule it rests on — here 21 CFR 202.1(e)(1)(v) — the precedent letters and a suggested revision.
The balance view compares the two parts of the spot: 31 s of benefit against 21 s of risk, 66 words against 67, 2.2 against 3.2 words per second, 1.9 against 6.7 shots per 10 seconds, a 74 px benefit super against a 22 px risk super. The major statement takes 35% of the spot.
“Time alone is not balance: what matters is whether a viewer can take it in — pace, text and what else is on screen.”
Six letters from the library match. The closest, 91% similar, is a Sep 9, 2025 letter about a 60-second TV ad for a plaque psoriasis biologic: “rapid scene changes between active, outdoor scenes, together with background music.” Company and product names are removed from every letter.
Priya decides each finding — ask for revision, accept with note, or not an issue — and asks for all five. The revision writer drafts one request to Lena Ortiz at Harborline Health, cc Sam Patel and Omar Haddad, with a target number on every item: no more than 6 calm shots under the risks, the risk super for the whole 0:31–0:52 with every key term, 44 px or more on a dark band, the major statement re-recorded at 2.8 words a second, the music ducked at least 6 dB.
A person sends — the agent drafts. No new claims in suggested revisions.
Harborline uploads cut v5 and the audit runs again. Every finding from cut v4 is resolved: 1.6 shot changes per 10 seconds, risk text for 100% of the major statement at 4.4% of the frame and 9.8 : 1, pace 1.13× with the music 8 dB down, all 4 label risks spoken, adequate provision 4 of 4. Eight checks pass, and the two cuts can be compared side by side.
“Every finding from cut v4 is resolved. 5 issues fixed.”
Priya signs AD-611 cut v5: the meaning — “Approved for air — regulatory review” or “Approved for air with conditions” — her name and role, 8 checks passed, and her password. Because this is national TV, Omar Haddad is asked for the legal signature next.
“Recorded with meaning, name and time.”
Dr. Maya Chen confirmed the claims on the script on Sep 23; Priya and Omar sign on Oct 7. AD-611 is cleared to air, and the Form 2253 packager builds the submission — final cut, script with timings, current Prescribing Information and the sign-off record — for Dana Okafor to file at first use, by Oct 26.
The same :60, seen by the people who carry it to air — what their review cycle looked like, and what it looks like now.
Six specialist agents frame, align, measure and match every cut, then write the revisions and the filing; the regulatory lead decides each finding.
Breaks each cut into shots, reads every super — text, size, contrast, time on screen — transcribes the voice-over with word timings and measures the music level. Splits web pages and posts into screens.
Lines the voice-over and supers up against the Prescribing Information: is each benefit claim on label, and is every most-serious risk in the major statement, spoken and shown.
Measures the major statement against the clear, conspicuous and neutral standards: shot changes, risk text coverage, text size and contrast, voice pace and music level — and raises a timestamped finding when a threshold is crossed.
Finds the FDA letters in the precedent library that objected to the same thing — same media, same theme — and quotes the passage, at most three per finding, most similar first.
Turns the findings the reviewer asked to revise into one timestamped request to the agency producer, with the number the next cut must meet, in plain words.
Builds the Form FDA 2253 submission for a cleared creative: the final cut, script, current Prescribing Information, dissemination date and sign-off record.
Decides each finding; legal signs. The agents propose; a named person decides.
The review team can ask about any creative, finding or letter — or tell it what to change. Every answer points to the cut, the rule or the letter behind it.
Why could the Veltrimab :60 draw a letter?
Five things in cut v4, all around the major statement (0:31–0:52): busy visuals — 14 shots in 21 s, kayaking, mountain biking, beach volleyball, which the September 2025 letters objected to; the risk text disappears at 0:40 and “liver problems” is never shown; the risk super is 22 px at 2.1 : 1; the risks are read faster, over music 5 dB louder; and the montage implies more than clearer skin.
What does “dual modality” require?
For TV, the major statement must be in the voice-over and on screen at the same time, with at least the key terms of the audio shown verbatim and long enough to read. In AD-611 cut v4 the risk super leaves at 0:40 while the voice-over runs to 0:52, and “liver problems” is spoken but never shown. The 2025 letters cite the same gap.
Which creatives air in the next 3 weeks with open findings?
Five are not cleared yet: the Corventa creator post (Oct 15, with the agency), the Talmirex.com home page (Oct 20), and the Veltrimab :60, streaming cut and social cutdown (Oct 26). The biggest exposure is AD-611, the $4.2M national flight on Oct 26.
Flag risk text with contrast below 7 : 1
Done. Risk text must now reach 7 : 1 contrast against its background, up from 4.5 : 1. AD-624 is newly flagged — its risk band is a light grey at 6.2 : 1. The change is saved as a new version of the thresholds for Omar Haddad’s approval and recorded in the audit trail.
13 screens from the working solution, on its sample data. Pick one to see it large.
The numbers the meter measures against, and who signs, are settings — each threshold shows which cuts it would flag today before you change it.
| Setting | Default | Choose from |
|---|---|---|
| Shot changes under the major statement | 3 per 10 s, at most | 1 to 8 per 10 s |
| Risk text on screen | 100% of the major statement | 50 to 100%, in steps of 5 |
| Risk text size | 4.0% of the frame, at least | 2 to 8%, in steps of 0.5 |
| Risk text contrast | 4.5 : 1, at least | 3 : 1 to 12 : 1 |
| Voice pace of the risks | 1.30× the benefit part, at most | 1.00× to 2.00× |
| Music under the risks | 0 dB against the benefit part, at most | −12 to +6 dB |
| Reading grade of the major statement | 8.0, at most | 5 to 12 |
| Legal second signature | Required for national TV | On · off, with Omar Haddad’s approval |
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 creatives · “target” = the design goal, measured in the live solution · “estimated” = our estimate · Sources: 21 CFR 202.1(e) · FDA major statement final rule (2023) · FDA untitled letters, September 2025. People, brands and agencies named on this page are characters in the working solution.
A check of how a direct-to-consumer ad presents its risks: whether the major statement is clear, conspicuous and neutral, and whether benefit and risk are in fair balance. The DTC Risk-Presentation Auditor measures it on every TV, streaming, radio, social and web creative before a reviewer watches it, and writes a cited finding for each issue.
The media framer breaks the cut into shots, supers and timed words. The risk presentation meter then compares the major statement with the benefit part: shot changes per 10 seconds, the share of it with risk text on screen, text size and contrast, voice pace, music level and reading grade — each against a threshold you set.
Yes. The precedent library holds 64 public FDA untitled and warning letters about promotion, with company and product names removed, indexed by theme — competing visuals, dual modality, text legibility, audio pace and music, overall impression, omitted risk, adequate provision and risk placement. New letters are added every Monday, and each finding quotes the closest ones.
Yes. Web pages and posts are measured screen by screen: where risk information starts, how it is set against the body copy, and whether the most-serious risks are in the post itself rather than behind a link. In the working solution it flags a home page whose risk starts on screen 4 of 4, and a creator post that carries none of the boxed-warning risks, only “Safety info in bio link.”
It prepares it. When a creative is cleared, the Form 2253 packager builds the package — the cleared cut, final script, current Prescribing Information and the sign-off record — and compliance operations files it at first use.
Yes. The agents measure and propose; the regulatory advertising lead decides every finding before anything goes to the agency, and a person sends every revision request. Clearance is signed with its meaning, name and time, national TV needs a legal second signature, and accepting a finding with a note needs a second person’s approval.
Yes. Shot changes, risk text coverage, size and contrast, voice pace, music level and reading grade are settings. Each one shows which cuts it would flag today, and a change is saved as a new version for approval.
The Agentic Solution Engine builds and deploys it from your requirements — your review standards, Prescribing Information and a sample of past creatives — and it goes live once every quality gate has passed. We will walk you through it on your own cuts first.
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