Your MSL can say it. Your rep can't. Here's where the line actually sits

Ask a medical science liaison and a sales rep the same question about an unapproved use, and you should get two very different responses. The MSL may be able to discuss the published evidence in depth. The rep should offer to pass the question to Medical and move on. Same company, same drug, same physician. The difference is not the information. It is whether the communication is promotional, and that line shapes nearly every content and field decision a pharma company makes.

This guide explains where the line sits, how FDA treats the main kinds of communication that sit near it, what medical and commercial teams can each do, and how to keep content on the right side of it as the same evidence gets reused across functions.

What makes content promotional?

In the US, promotional labeling and advertising are communications by or on behalf of a company that promote a product. Whether something counts is judged on substance and context, not on what it is called. A slide deck labeled scientific becomes promotional when it is used to sell, and a conversation becomes promotional when a commercial employee steers it toward a product's benefits.

Promotional content must be consistent with the approved labeling, supported by substantial evidence, balanced for risk, and submitted to FDA at first use. It cannot promote unapproved uses. Most of what brand teams produce, from detail aids to approved emails to DTC campaigns, sits clearly on this side.

Medical communication is the exchange of scientific information that is not intended to promote. It includes responding to unsolicited questions, presenting data at scientific congresses, publishing research, and the scientific exchange MSLs have with experts. It is reviewed differently, usually by medical review rather than the promotional MLR process, and it is kept separate from commercial goals in who delivers it, how it is funded and how the people involved are measured.

What can an MSL say that a rep cannot?

MSLs work in medical affairs, not sales. They are typically scientists or clinicians, they are not paid on sales results, and their conversations with experts are meant to be balanced scientific exchange. In that role, they can respond in depth to unsolicited questions, including about unapproved uses, with information that is accurate, balanced and tailored to the question.

Reps represent the commercial organization, so whatever they say about a product is promotion. They discuss the approved use, using approved materials, and when a physician asks about something outside the label, they do not answer it. They offer to submit a medical information request, and the company's medical team responds.

The separation works only if it is real. An MSL who is briefed by sales on which accounts to visit and what to say, or a rep who invites an MSL to a call to talk about an unapproved use, collapses it, and makes the MSL's communication promotional in substance. Most companies set out the rules for joint activities in detail for this reason.

How should companies respond to unsolicited requests about off-label use?

When a healthcare professional asks, unprompted, about an unapproved use, the company can respond. FDA's long-standing approach to unsolicited requests is that a response should go only to the person who asked, should be tailored to the specific question, should be truthful, balanced and scientifically sound, and should come from medical or scientific staff rather than sales or marketing.

The key word is unsolicited. A request prompted by the company, for example by a rep raising the topic, a promotional piece that hints at a use, or a campaign that invites questions about it, is solicited, and a response to it can be treated as promotion of an unapproved use.

Public questions are handled differently from private ones. If someone asks about an unapproved use in a public forum such as social media, the usual approach is to respond publicly only with a statement that the question is about an unapproved use and contact details for the medical team, and to answer the substance privately.

What do FDA guidances allow companies to share proactively?

Two FDA guidances define the space between the label and an unapproved use. The first, on communications consistent with the FDA-required labeling, finalized in 2018, covers information that is not in the label but is consistent with it, such as data on the approved use in an approved population that the label does not include. Companies can share this in promotion, provided it is consistent with the label on the conditions of use, does not increase the product's risks, is truthful and not misleading, and is presented with appropriate context.

The second, on scientific information on unapproved uses, finalized in January 2025, covers proactive sharing of scientific information about unapproved uses with healthcare providers, such as published clinical studies. FDA describes when it does not intend to treat such communications as evidence of a new intended use: the information should be scientifically sound and clinically relevant, presented truthfully and without misleading, with disclosures that the use is unapproved and about the study’s limitations, and kept clearly separate from promotional communications.

A third guidance, on communications with payors, formulary committees and similar entities, covers health care economic information and information about investigational products and uses shared with payors before approval. It applies to payor audiences, not prescribers.

These guidances describe FDA’s current thinking and contain specific conditions. Legal and regulatory teams should interpret them for each use, and many companies keep stricter policies than the guidances require.

How the line blurs in content operations

Most problems happen when evidence travels between functions. A congress poster prepared by Medical is excerpted into a sales training deck. A publication summary becomes a slide in a detail aid. A medical information response letter is quoted in an approved email. Each move takes content written to one standard and puts it into a channel judged by another.

The same happens with claims. A secondary analysis that is appropriate in scientific exchange may not be a claim the company can make in promotion. If the claims available to brand teams are not clearly separated from the evidence available to Medical, the line moves every time someone reuses a slide.

The fix is structural. Keep approved promotional claims in their own library, with their status, their references and the channels they are approved for. Keep medical content in its own system, reviewed by its own process. And make sure any tool that generates promotional content can only reach the promotional library.

Where SwishX fits

Magic Studio writes promotional assets only from the claims and dossiers your team has approved for promotion, with every claim cited to its source and checked against the label for its market. Content that is approved for medical use only is not available to it, so evidence cannot drift from scientific exchange into promotion through a reused slide.

Magic Academy trains reps on the same boundary. Every practice conversation is scored on whether the rep stayed on label, presented risk in balance and referred off-label questions to Medical, so the first time a rep is asked about an unapproved use is not in front of a physician.

Frequently asked questions