When Does Scientific Exchange Become Promotion? The NewCompliance Line for Medical Science Liaisons

Medical Science Liaisons have never been more important—or more difficult to
manage from a compliance perspective.
Pharmaceutical and biotechnology companies increasingly rely on Medical Science
Liaisons (“MSLs”) to engage healthcare professionals in sophisticated scientific
discussions, communicate emerging evidence, identify unmet medical needs, support
research, and provide insights back to the organization.
But as the role of Medical Affairs expands, so does one of the most important
compliance questions facing life sciences companies:
When does legitimate scientific exchange cross the line into promotion?
That question has become particularly important following FDA’s January 2025 final
guidance addressing certain communications of scientific information concerning
unapproved uses of approved or cleared medical products, commonly referred to as
the SIUU guidance. See https://www.fda.gov/media/184871/download. FDA also issued
revised draft guidance in June 2026 regarding communications of health care economic
information (“HCEI”) to payors, formulary committees, and similar entities. See
https://www.fda.gov/media/133620/download. Together, these developments
underscore something companies sometimes overlook: simply placing a communication
within Medical Affairs—or having an MSL deliver it—does not automatically make the
communication non-promotional.
The MSL Title Is Not a Compliance Safe Harbor
A common misconception is that an MSL may discuss information that a sales
representative cannot because the MSL sits within Medical Affairs. That is too
simplistic.
MSLs certainly have a different role from commercial sales personnel. They generally
possess advanced scientific expertise, engage in peer-to-peer scientific discussions,
respond to medical inquiries, discuss clinical evidence, support research activities, and
communicate with healthcare professionals about complex scientific issues.
But compliance ultimately depends on what is being communicated, why it is being
communicated, to whom, how the interaction originated, and how the company
structured the communication. Calling someone an MSL does not transform
promotional messaging into scientific exchange. The compliance analysis must follow
the activity—not the employee’s title.

The Biggest Question: Reactive or Proactive?
Historically, pharmaceutical companies have focused heavily on whether an MSL’s
discussion of an unapproved use occurred in response to a genuine unsolicited request
from a healthcare professional. That remains important.
But FDA’s more recent framework also addresses certain firm-initiated
communications of scientific information concerning unapproved uses. FDA’s January
2025 guidance describes an enforcement policy for qualifying communications to
healthcare professionals involving specified scientific sources, including published
journal articles, clinical practice guidelines, reference texts, digital clinical practice
resources, and certain firm-generated presentations accompanying those sources.
FDA states that where communications satisfy the recommendations described in the
guidance, the Agency does not intend to rely on the communication, standing alone, as
evidence of a new intended use. (U.S. Food and Drug Administration)
That does not, however, mean that an MSL suddenly has unlimited authority to
proactively discuss off-label uses. The details matter enormously. Companies need to
consider issues such as the quality and independence of the scientific source,
presentation of contrary or limiting evidence, appropriate disclosures, separation from
promotional communications, the intended audience, and whether company-generated
materials accurately reflect the underlying scientific literature.
There is consequently a substantial difference between:
“An MSL may discuss scientific information.”
and
“An MSL may proactively initiate any scientifically supportable off-label
discussion.”
Those propositions are not interchangeable.
Scientific Exchange Cannot Become a Commercial Workaround
Another risk arises when an organization uses Medical Affairs to accomplish indirectly
what Commercial cannot accomplish directly. Consider a sales representative who
learns that a physician may be interested in an unapproved use and immediately
arranges for an MSL to visit the physician. That interaction is not necessarily improper.
Commercial personnel may appropriately facilitate access to Medical Affairs in many
circumstances. But companies should examine the surrounding facts:
Was there actually a medical question? Was the MSL requested because scientific
expertise was needed? Or is the organization’s commercial strategy systematically
using MSLs to advance discussions that sales representatives are not permitted to
conduct? Patterns matter.
Compliance concerns increase when MSL deployment is tied closely to sales
objectives, when commercial personnel script or direct Medical Affairs discussions,

when MSL targeting mirrors promotional targeting without a scientific rationale, or when
MSL activity is measured primarily by commercial outcomes.
Medical Affairs should appropriately collaborate with Commercial—but it should not
become an extension of the sales force.
The Same Problem Is Emerging with HEOR and Market Access
The boundary becomes even more complicated when Medical Affairs interacts with
health plans, formulary decision-makers, integrated delivery networks, or other entities
evaluating population-level health care decisions.
FDA issued revised draft guidance in June 2026 addressing communications of health
care economic information and other information to payors, formulary committees, and
similar entities.
The guidance addresses, among other things, HCEI regarding approved products as
well as certain information concerning unapproved products and unapproved uses. See
https://www.fda.gov/media/133620/download. This raises an increasingly important
operational question:
Who should communicate what—MSLs, HEOR personnel, National Account
Managers, Market Access, or Commercial?
There is no universal answer. Companies should instead establish audience-specific
and content-specific rules governing which functions may communicate particular
categories of information. An MSL’s scientific expertise does not necessarily make the
MSL the appropriate person to deliver every economic, formulary, reimbursement, or
population-health communication. Likewise, information that may appropriately be
communicated to a sophisticated payor audience may not be appropriate for broader
dissemination to individual prescribers or sales personnel.
Seven Questions Companies Should Be Asking About Their MSL Programs
For compliance teams evaluating field Medical Affairs activities, these questions are
increasingly important:

1. How does the company define scientific exchange? If the answer is simply
   “anything communicated by Medical Affairs,” the policy needs work.
2. When may an MSL proactively initiate a scientific discussion? Policies
   should distinguish proactive scientific communications from responses to
   unsolicited requests.
3. What materials may MSLs use? There should be clear governance for
   publications, slide decks, congress materials, clinical practice guidelines, pipeline
   information, real-world evidence, and company-generated scientific
   presentations.
4. How are Commercial-to-MSL referrals handled? The process should permit
   legitimate scientific engagement without creating a mechanism to manufacture
   “unsolicited” requests.
5. How are MSLs evaluated? Compensation and performance metrics should
   reinforce scientific objectives rather than function as indirect sales incentives.
6. Who owns HEOR and payor communications? Medical, Market Access,
   HEOR and Commercial responsibilities should be explicitly defined.
7. Can the company reconstruct what happened? Documentation, training,
   approved materials and escalation procedures become particularly important
   when the scientific discussion involves an unapproved use.
   MSL Training Needs to Move Beyond “Don’t Promote”
   Many MSL compliance programs still rely on broad instructions such as:
   “Do not promote” is no longer enough.
   An effective Medical Affairs compliance program should teach MSLs how to recognize
   the factual circumstances that change the regulatory analysis.
   For example, training should address how to distinguish an unsolicited medical inquiry
   from a commercially prompted discussion; when proactive scientific communication may
   be appropriate; what disclosures should accompany scientific information; how to
   discuss limitations in available evidence; when to redirect an interaction; and when
   Legal, Regulatory or Compliance review is required.
   Scenario-based training is particularly important. The difficult compliance questions
   rarely arrive in neat hypothetical form. They occur when an oncologist asks one
   additional question during dinner, when a sales representative texts an MSL from the
   parking lot, when a new publication appears before an internal deck has been
   approved, or when an MSL is asked to participate in a discussion involving
   reimbursement, economic evidence and clinical outcomes simultaneously.
   Those are the moments in which a well-designed compliance program matters.
   The Bigger Compliance Lesson
   The regulatory environment is creating more opportunities for sophisticated scientific
   communication—not fewer. But increased flexibility does not eliminate the need for
   boundaries.
   As Medical Affairs becomes increasingly strategic within pharmaceutical and
   biotechnology companies, organizations should resist two extremes: unnecessarily
   restricting legitimate scientific exchange on one hand and treating Medical Affairs as a
   regulatory workaround for Commercial on the other.

The better approach is to build clear, defensible rules regarding who may communicate,
what they may communicate, to whom, under what circumstances, using what
materials, and with what documentation.
For today’s MSL organization, that may be one of the most important compliance
exercises a life sciences company can undertake.
This article is for informational purposes only and does not constitute legal advice.
Kendall PC advises pharmaceutical, biotechnology and medical device companies on
Medical Affairs, MSL compliance, scientific exchange, promotional practices, FDA
requirements, and the development of practical Medical–Commercial interaction policies
and training programs.