Advertising &
Promotional
Review
Leaders in Promotional Compliance
Leaders in Promotional Compliance
OPDP and APLB read your promotion the way a reviewer reads a submission: claim by claim, against the label, against the data, and against everything your competitors have already been cited for. One overstated benefit or a risk statement buried below the fold can pull a campaign, draw an untitled letter, and stall a launch a decade in the making. We put senior medical, regulatory, and legal reviewers inside your process, so material moves fast because it is right, not because no one looked closely.
Claims that sell without inviting a letter. We read them the way OPDP will, before the market does.
A promotional claim is never read on its own. OPDP weighs it against four things simultaneously, and a claim that fails any one of them is a claim that can be cited.
Is “proven” backed by adequate and well-controlled evidence, or by a single secondary endpoint stretched past what it can carry?
Is the risk information presented with comparable prominence, or does the benefit shout while the safety whispers?
Is “superior” a head-to-head result the data supports, or an implied comparison no trial was ever designed to make?
Does the claim stay inside the approved indication and label, or drift a step beyond what FDA actually cleared?
Each headline, footnote, and visual weighed against substantiation, fair balance, context, and the approved label at once.
A functioning MLR review is not a single sign-off. It is three disciplines interrogating the same material from three angles, each catching what the others are not built to see.
Material clears quickly when three reviewers agree, not when nobody looked closely.
The scientific reviewer
Traces every claim back to the study behind it and flags the technically-true-but-misleading: a secondary endpoint shown as primary, a subgroup generalized to the whole label population.
The compliance reviewer
Reviews against the label, the approved indication, and OPDP's live enforcement patterns, so fair balance is a case that holds rather than a formatting checkbox.
The risk reviewer
Weighs the liability, the competitive challenge, and the precedent a claim sets, because a promotional record follows a product for its entire life on the market.
OPDP enforcement is not random. It clusters around a handful of recurring patterns, and knowing them is how a reviewer stops a claim before it becomes a citation.
A benefit claimed more broadly or more certainly than the data supports, the single most common OPDP finding.
Safety information present but de-emphasized: small type, a fast scroll, or a placement where a reader will not weigh it.
An implied or explicit comparative claim with no head-to-head trial standing behind it.
Leaving out a limitation, contraindication, or condition of use that changes how the claim should be read.
Promoting a use, population, or dose the approved label does not cover, the finding with the sharpest consequences.
Promoting a product or indication before FDA has approved it, a line that launch and pipeline pressure constantly test.
OPDP letters cluster around a handful of recurring patterns. Knowing them is how a reviewer stops a claim before it ships.
Promotional enforcement runs on a ladder of rising consequence. The distance between the first rung and the last is measured in credibility, revenue, and years, and the response to the first letter often decides how far up you climb.
An untitled letter gives you days, and the first response sets the tone for everything after it.
A request to correct: pull the piece, sometimes run corrective communication. Handled well and fast, it closes quietly.
A formal, public finding of violation, citable by competitors and often demanding corrective advertising to the same audience that saw the claim.
Court-enforced oversight of your promotional practices: pre-clearance, monitoring, and penalties that reshape how the company markets for years.
And none of it relaxes online. A ninety-character paid-search ad carries the same fair-balance obligation as a journal spread, and a sponsored influencer post is promotion in your name, on a channel FDA is increasingly watching.
We do not sit outside your MLR as one more bottleneck. We build the function, run the reviews, file what FDA requires, and stand up the moment a letter arrives.
Journal, sales aid, website, paid search, and social, all held to the same bar.
A PRC/MLR charter, roles, and service levels, plus senior reviewers who clear the queue at launch volume without cutting corners.
Form 2253 filed at initial dissemination, with the tracking and record that proves exactly what went out, and when.
The review function stood up before the label is, so the riskiest, highest-volume moment of a product's life is the one you are most ready for.
When an untitled or warning letter lands, we draft the response that closes it and protects the record for everything that follows.
Promotional review is judgment: knowing which claims OPDP actually pursues, how much substantiation a word like “proven” requires, and where fair balance really lands. Your reviewers are senior medical, regulatory, and legal practitioners who have built MLR functions, cleared launch campaigns, and answered the letters when they came.
We review against what OPDP is citing now, not a static house template, so fair balance is a case that would actually hold.
Senior reviewers clear the queue at launch volume, because slow review is as expensive as a pulled campaign.
Journal, sales aid, website, paid search, social, and congress, each with its own way to break the same rules.
Launch and accelerated approval are the highest-risk promotional moments; we build the review that holds under that pressure.
A claim traces back to the label and forward into the market. These are the services promotional review most often touches.
Every promotional claim answers to the label, the source document your marketing is measured against, built to hold.
Explore Labeling →The data and documents your claims are drawn from, written so the substantiation is there when OPDP asks for it.
Explore Writing →The strategy and agency relationships behind a launch, so promotion is one part of a coherent FDA plan.
Explore Consulting →Tell us where your program stands: pre-launch, mid-campaign, or mid-remediation, and what your material volume looks like. We'll match you with a senior review lead and respond within one business day. All inquiries are strictly confidential.
