DTC fair balance review that measures every cut before it airs — benefit time, risk time and what the picture does under every risk statement
Every TV, streaming and social cut checked for risk presentation before review
See one case, screen by screen ↓It is the check that a prescription-drug ad to consumers presents its risks with a prominence reasonably comparable to its benefits, and that a TV or radio ad's major statement is clear, conspicuous and neutral. DTC Fair Balance Review measures that on the cut itself — benefit time, risk time, and what the picture, text, voice and music do under every risk statement — for the regulatory reviewer to decide.
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A DTC TV or streaming ad must present its risks with a prominence reasonably comparable to its benefits, and since May 2024 its major statement must be clear, conspicuous and neutral: risks spoken and shown at the same time, text large and long enough to read, the voice at least as easy to follow as the rest of the ad, and nothing on screen or in the soundtrack that gets in the way. Today the reviewer scrubs each cut by hand, writes timecoded comments, and argues “is this distracting?” from memory of past letters.
In September 2025 FDA posted dozens of untitled letters against DTC ads, most for exactly what the eye misses: lifestyle montages and fast cuts under the risks, risk text that comes and goes, risks read faster than benefits. A reviewer watching a :60 cannot count 14 shot changes in 21 seconds, read a 22-pixel super at 2.1 : 1 contrast, or hear that the voice speeds up 45% under the risks. Each revision round costs days against a fixed air date, and a letter after air means pulled media and a corrective campaign.
Estimated split of the reviewer's own time on one round of review of a national TV cut, by hand and with the solution — agency turnaround not included.
Six agents frame, time and match every cut, then draft the revisions and the filing; the regulatory lead decides each finding.
Northwind Bio's Veltrimab, a plaque psoriasis biologic, has a $4.2M six-week national flight starting Oct 26. Harborline Health sends cut v4 of “Back to the everyday” at 07:52. Here is what happens next, screen by screen, in the working solution.
AD-611 opens as an ad timeline: a strip of 21 shots with tracks for shot changes, voice-over in words per second, supers with their seconds on screen, and music in dB. Benefit runs 0:00–0:31 (31 s), the risk statement 0:31–0:52 (21 s), learn more 0:52–1:00. It airs in 19 days; the spot bin above holds every TV, streaming and social cut in review.
“The agents time every second of the spot: how long benefit and risk each hold the screen, what the picture does under every risk super, and whether the text, voice and music let the risks through.”
The playhead sweeps the spot and flags drop at their timestamps. At 0:42 the second risk super — “Serious allergic reactions · Liver problems · Get help right away” — lands over fast cuts: barbecue, paddle splash, bike jump over roots, diving for the ball, outdoor concert. That is 8 shot changes in 9.5 s, 8.4 per 10 s against a limit of 3. The Sep 9, 2025 letter on a psoriasis biologic TV ad sits beside it.
Letter quoted: “The major statement is presented while the ad shows rapid scene changes between active, outdoor scenes, together with background music.”
Competing visuals: 14 shots in 21 s under the risks, one every 1.5 s, against one every 5.2 s in the benefit part. Risk text on screen for only 88% of the major statement — none from 0:40 to 0:42. The first risk super is 22 px at 2.1 : 1. Risks read at 3.2 words a second against 2.2 for the benefit, over music 5 dB louder. And the “Back to the everyday” montage implies more than clearer skin.
“The label supports skin clearance (PASI 90 at week 16), not activity or quality-of-life outcomes.”
Each finding carries the letters on its theme — 6 for this cut — from a library of 64 FDA untitled and warning letters, indexed by what they objected to: competing visuals, dual modality, text legibility, audio pace and music, overall impression. Company and product names are removed, and the passage that matters is marked.
Priya decides each finding — ask for revision, accept with note, or not an issue — and here asks for all five. The Revision writer drafts one timecoded request to Lena Ortiz at Harborline Health, cc Sam Patel and Omar Haddad, with the number the next cut must meet: no more than 6 calm shots in 0:31–0:52, the risk super for the whole major statement, 44 px or more on a dark band, the major statement at 2.8 words a second or slower, the music ducked at least 6 dB.
“Please upload the next cut by Oct 9. We re-measure it the moment it lands.”
Harborline uploads cut v5. The Media framer reads 10 shots, 4 supers and 142 timed words; the Claim & risk aligner finds 4 of 4 most-serious risks spoken; the Fair-balance timer measures 1.6 shot changes per 10 s, risk text for 100% of the major statement and 2.5 against 2.2 words a second; the Precedent matcher finds no letter that matches.
All five issues are fixed in cut v5 and 8 checks pass: calm shots under the major statement, risk text shown with the voice-over, text at 4.4% of frame height and 9.8 : 1, voice pace 1.13× with the music 8 dB down, 4 of 4 label risks spoken, an overall impression on label and 4 of 4 adequate-provision sources.
“Every finding from cut v4 is resolved. 5 issues fixed — compare the two cuts on the Balance tab.”
Priya signs for air with the meaning “Approved for air — regulatory review”. Because AD-611 is national TV, Omar Haddad, promotional legal counsel, is asked for the legal second signature next. Dr. Maya Chen had already confirmed the claims on the script against the label.
“Recorded with meaning, name and time. Omar Haddad is asked for the legal signature next.”
Once both signatures are in, AD-611 is cleared to air and the Form 2253 packager builds the submission from the cleared cut: applicant, product, application, material ID AD-611-v5, first dissemination Oct 26, 2026, with the final cut, the script with timings, the current Prescribing Information and the sign-off record. Dana Okafor in compliance operations files it.
The packager prepares; compliance operations files.
The same :60, seen by the five people who carry it to air — how their review looked, and how it looks now.
Six agents frame, time and match every cut, then draft the revisions and the filing; the regulatory lead decides each finding.
Breaks each cut into shots, reads every super — text, size, contrast and time on screen — transcribes the voice-over with a time for every word and measures the music level. Web pages and posts are split 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. Judges whether the visuals and tagline imply more than the label supports.
Times every second of the spot: benefit time against risk time, shot changes under each risk super, risk text coverage, size and contrast, voice pace and music — and raises a finding with its timestamp when a threshold is crossed.
Finds the FDA letters in the precedent library that objected to the same thing in the same media, 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, each item with the number the next cut must meet, in plain words.
Builds the Form FDA 2253 submission for a cleared creative: the final cut, the script, the current Prescribing Information, the dissemination date and the sign-off record.
Decides each finding; legal signs. The agents propose; a named person decides.
Ask in plain words, or say what to change. Every answer shows the passage or the timestamp 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, one every 1.5 s; the second risk super lands at 0:42 over the fastest cuts, and no risk text is on screen from 0:40 to 0:42; the risk super is 22 px at 2.1 : 1, white on sand; risks are read 45% faster, over music 5 dB louder; and the montage implies more than clearer skin.
How small is too small for risk text?
The rule asks that size, style, contrast and placement let the text be read easily. We measure it: risk text must be at least 4.0% of the frame height — 44 px on 1080 — and 4.5 : 1 contrast. AD-611 v4 shows 22 px at 2.1 : 1, white on sand; the brand template's dark band gives 9.8 : 1.
Is the risk read too fast?
In AD-611 cut v4, yes: the major statement runs at 3.2 words a second against 2.2 for the benefit — 45% faster — and the music rises 5 dB under it. The audio must be at least as understandable as the rest of the ad; a radio letter in 2025 objected to the same thing.
When do we file Form 2253?
At the time of first use — when the ad first airs. When you sign a creative, the Form 2253 packager builds the package — cleared cut, script, current Prescribing Information and the sign-off record — and Dana Okafor files it.
13 screens from the working solution, on its sample data. Pick one to see it large.
The fair-balance timer flags a cut when the major statement crosses these, and each threshold shows which cuts it would flag today.
| Setting | Default | Choose from |
|---|---|---|
| Shot changes under the major statement | 3 per 10 s, at most | Step up or down; the impact line shows which cuts it flags today |
| Risk text on screen | 100% of the major statement | Step up or down |
| Risk text size | 4.0% of frame height (cap height), at least | Step up or down |
| Risk text contrast | 4.5 : 1 against its background, at least | Step up or down, or describe a rule — e.g. 7 : 1 |
| Voice pace of the risks | 1.30× the benefit part, at most | Step up or down |
| Music under the risks | 0 dB against the benefit part, at most | Step up or down |
| Reading grade of the major statement | 8.0, at most | Step up or down |
| Legal second signature | Required for national TV before clearance | On · off (turning it off needs 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 · “typical” = published figures (FDA untitled letters, September 2025, as counted by FDA Law Blog and Mintz). Rules cited: 21 CFR 202.1(e)(1) and (e)(5)(ii); FDA major statement final rule (2023). People, companies, products, agencies and the letter passages in the precedent library shown on this page are characters and sample data in the working solution.
It is the check that a prescription-drug ad to consumers presents its risks with a prominence reasonably comparable to its benefits, and that a TV or radio ad's major statement is clear, conspicuous and neutral. DTC Fair Balance Review measures that on the cut itself — benefit time, risk time, and what the picture, text, voice and music do under every risk statement — for the regulatory reviewer to decide.
The Fair-balance timer counts shot changes per 10 seconds under each risk super and compares them with the benefit part and your threshold — 3 by default. In the working solution's :60, the second risk super ran over 8.4 shot changes per 10 s against 1.9 in the benefit part, and was flagged at 0:42.
Yes. It measures how much of the major statement has risk text on screen, the text's size and contrast, the key terms spoken and shown, the voice pace of the risks against the benefit, the music level under the risks and the reading grade.
The Precedent matcher searches a library of public FDA untitled and warning letters, indexed by theme and media, and quotes the passage that objected to the same thing beside each finding. Company and product names are removed, and new letters are added every Monday.
Yes. It reviews TV, streaming, radio, social video and web pages. Pages and posts are measured screen by screen — for example, risk information that starts only on screen 4 of 4, or a creator post that says “safety info in bio” instead of stating the boxed-warning risks.
Yes. Agents measure and propose; only the regulatory advertising lead decides each finding. The Revision writer drafts and a person sends, national TV needs a legal second signature, and compliance operations files the Form 2253 package.
Yes. Shot changes, risk text coverage, size and contrast, voice pace, music level and reading grade are all settings, and each shows which cuts it would flag today. Thresholds change only through an approved version, on the audit trail.
The Agentic Solution Engine builds and deploys it from your requirements and documents — your review standards, Prescribing Information and a sample of past cuts — 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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