Medical Affairs vs. Commercial: FDA Rules & Compliance

Learn when Medical Science Liaisons (MSLs) and Sales Representatives may collaborate, FDA expectations, scientific exchange rules, compliance risks, and today’s best practices

Introduction
Medical Affairs has evolved into one of the most strategically important functions within
pharmaceutical, biotechnology, and medical device companies. As organizations increasingly
rely on Medical Science Liaisons (MSLs) to engage healthcare professionals, answer complex
scientific questions, collect clinical insights, and support evidence generation, one compliance
question continues to arise:

Can MSLs and Commercial Sales Representatives work together?
The answer is nuanced.
While collaboration between Medical Affairs and Commercial is both expected and
necessary, the independence of Medical Affairs must be preserved. Failure to establish
and maintain appropriate boundaries may expose a company to significant regulatory scrutiny,
government investigations, False Claims Act litigation, FDA enforcement, Corporate Integrity
Agreement (CIA) obligations, and reputational harm.
Contrary to popular belief, there is no federal law that expressly prohibits communication
between Medical Affairs and Commercial teams. However, regulators have consistently
emphasized that scientific exchange must remain separate from promotional activities. The
challenge for companies is identifying where legitimate collaboration ends and impermissible
commercial influence begins.
This guide explains those boundaries, examines common risk areas, provides practical
compliance recommendations, and answers the questions most frequently asked by
pharmaceutical executives, Medical Affairs leaders, compliance officers, and in-house counsel.
Why Medical Affairs Independence Matters
Medical Affairs exists to support the appropriate use of medical products through unbiased
scientific engagement. Unlike Commercial organizations, Medical Affairs is not responsible for
achieving sales quotas or driving promotional campaigns.
Its responsibilities typically include:

• Scientific exchange with healthcare professionals
• Responding to unsolicited medical information requests
• Medical education
• Publication planning
• Investigator-sponsored research
• Advisory boards
• Medical insights collection
• Evidence generation
• Clinical support
• Internal scientific expertise
  
  Commercial organizations, by contrast, focus on promoting FDA-approved products for approved indications through compliant promotional activities. Although these objectives complement one another, they must not become indistinguishable.

When Medical Affairs appears to function as an extension of Sales, regulators may conclude that

scientific interactions are promotional communications.

The Regulatory Landscape

No single regulation governs Medical Affairs. Instead, expectations arise from several

overlapping authorities.

These include:

• Federal Food, Drug, and Cosmetic Act
• FDA regulations governing prescription drug promotion
• Department of Justice (DOJ)
• Office of Inspector General (OIG)
• Corporate Integrity Agreements (CIAs)
• FDA guidance on scientific exchange
• PhRMA Code on Interactions with Healthcare Professionals
• State marketing and transparency laws

Government investigations rarely focus on organizational charts alone.

Instead, regulators examine whether company conduct demonstrates that Medical Affairs

maintained scientific independence.

The Difference Between Medical Affairs and Commercial

The distinction seems straightforward. In practice, however, these activities frequently intersect.
Where Companies Get into Trouble

1. Commercial Directing Scientific Messaging
   Perhaps the most common enforcement concern occurs when Commercial personnel influence
   scientific communications.
   Examples include:
   ❌ Asking MSLs to emphasize certain efficacy endpoints
   ❌ Coaching MSLs before physician meetings
   ❌ Editing scientific slide decks to strengthen promotional messaging
   ❌ Requiring Medical Affairs to prioritize high-prescribing physicians
   ❌ Discouraging discussion of unfavorable data
   These actions may undermine Medical Affairs independence.
2. Sales Representatives Attending MSL Visits
   Can Sales attend MSL meetings?
   Sometimes.
   Joint visits may be appropriate when:
   ✓ Introducing the MSL
   ✓ Coordinating customer relationships
   ✓ Transitioning scientific discussions
   ✓ Responding to logistical questions
   However, risk increases substantially if Sales personnel:
   • Participate in off-label discussions
   • Ask scientific questions intended to prompt off-label dialogue
   • Influence physician questions
   • Redirect conversations toward promotional objectives
   • Remain present during unsolicited medical information requests
     Companies should adopt written policies governing joint calls.
3. Off-Label Scientific Exchange
   One of the most misunderstood concepts in Medical Affairs is off-label communication.

MSLs may respond to unsolicited requests regarding off-label uses when conducted through
appropriate scientific exchange.
Commercial representatives generally may not proactively promote unapproved uses.
Problems occur when:

• Sales asks the physician to ask the MSL a question
• Sales remains during detailed scientific discussions
• Commercial personnel document off-label conversations for sales purposes
• Marketing influences scientific responses

Diagram 1
Appropriate Information Flow
Marketing
     │
     ▼
Commercial Team
     │
     │ Approved Promotional Messaging
     ▼
Healthcare Professional
Medical Affairs
     │
     │ Independent Scientific Exchange
     ▼
Healthcare Professional
Healthcare Professional
     │
     ▼
Medical Insights
     │
     ▼
Medical Affairs
Key Principle: Scientific exchange should remain independent of promotional objectives.

Publications
Publication planning should be driven by legitimate scientific objectives—not commercial
priorities.

Appropriate Medical Affairs responsibilities include:

• Identifying publication opportunities
• Working with investigators
• Coordinating publication committees
• Ensuring publication ethics
• Managing disclosures

Commercial may appropriately provide business awareness but should not dictate scientific
conclusions.

High-risk examples include:

• Delaying publications until product launch
• Editing manuscripts to support promotional claims
• Selecting journals solely based upon marketing strategy

Advisory Boards
Government investigators routinely scrutinize advisory boards.
Medical Affairs should typically lead:

• Faculty selection
• Agenda development
• Scientific objectives
• Discussion topics
• Follow-up documentation

Commercial involvement should be carefully limited.
Red flags include:

• Sales selecting attendees
• Incentivizing participation based on prescribing volume
• Using advisory boards primarily as marketing events

Promotional Review Committees (PRC)
Medical Affairs often serves on Promotional Review Committees.
Participation itself is appropriate.
However, Medical reviewers should maintain scientific independence by evaluating:

• Scientific accuracy
• Fair balance
• Clinical context
• Appropriate references

Medical reviewers should not become advocates for stronger promotional claims.

Medical Information Requests
Medical Information departments frequently partner with MSLs.
Appropriate workflow:
Physician Question
        │
        ▼
Medical Affairs
        │
        ▼
Scientific Response
        │
        ▼
Physician
Inappropriate workflow:
Sales Representative
        │
        ▼
Suggests Question
        │
        ▼
MSL Response
        │
        ▼
Sales Uses Response
Government Enforcement Trends
Although every case differs, government investigations commonly involve allegations that:

• Medical Affairs acted as promotional sales support
• MSLs promoted off-label uses
• Advisory boards lacked legitimate scientific purpose
• Publications became marketing tools
• Speaker programs functioned as inducements
• Medical insights were used to target promotional messaging

Investigators often review:

• Emails
• Call notes
• CRM documentation
• Internal presentations
• Training materials
• Organizational reporting structures

Eight Compliance Best Practices

1. Establish Written Governance
   Clearly define:
   
   • Medical Affairs responsibilities
   • Commercial responsibilities
   • Escalation procedures
   • Interaction policies
     
2. Train Both Organizations
   Training should address:
   • Scientific exchange
   • Promotional boundaries
   • Off-label requests
   • Joint field visits
   • Documentation expectations
3. Maintain Independent Leadership
   Where practical:
   • Separate reporting lines
   • Independent performance objectives
   • Distinct budgets
4. Document Legitimate Scientific Purpose
   Every advisory board, publication, investigator meeting, and educational activity should have
   documented scientific objectives.
5. Develop Joint Call Procedures
   Address:
   • When joint calls are appropriate
   • Who leads discussions
   • When Sales exits conversations
   • Documentation expectations
6. Audit Medical Affairs Activities
   Monitor:
   • Call notes
   • CRM entries
   • Publications
   • Advisory boards
   • Medical information requests
7. Preserve Scientific Integrity
   Scientific conclusions should never be modified to strengthen commercial messaging.
8. Involve Legal and Compliance Early
   Many enforcement actions could have been avoided through proactive legal review.
   Compliance Checklist
   Before approving a Medical Affairs activity, ask:
   • Is there a legitimate scientific purpose?
   • Is Commercial directing the activity?
   • Could this appear promotional?
   • Is documentation complete?
   • Are appropriate personnel involved?
   • Is Medical Affairs acting independently?
   • Have Legal and Compliance reviewed high-risk issues?
     Frequently Asked Questions
     Can Sales attend advisory boards?
     Sometimes, but participation should be carefully controlled and generally limited. Medical
     Affairs should lead scientific content.
     Can Sales ask MSLs to visit physicians?
     Companies may coordinate customer engagement, but Commercial should not direct scientific
     discussions or influence the substance of MSL interactions.
     Can MSLs discuss off-label information?
     MSLs may respond to unsolicited scientific requests when conducted consistent with applicable
     company policies and regulatory expectations.

Can Commercial review publications?
Commercial may provide awareness of business considerations, but Medical Affairs should
maintain authority over scientific integrity.
Should Medical Affairs report into Commercial?
Many companies maintain separate reporting structures to reinforce independence, although
organizational models vary.
Can MSLs have sales goals?
Performance metrics should focus on scientific engagement, medical insights, evidence
generation, education, and other Medical Affairs objectives—not sales volume or prescription
growth.
Should MSLs use the same CRM system as Sales?
Many companies use shared technology platforms with carefully designed access controls,
separate workflows, and governance to preserve Medical Affairs independence.
What documents should every company maintain?
At a minimum:

• Medical Affairs Charter
• Scientific Exchange Policy
• Joint Field Visit SOP
• Medical Information SOP
• Publication SOP
• Advisory Board SOP
• MSL Activity Guidance
• Promotional Review SOP
• Off-Label Response Procedure
• Monitoring and Auditing Plan

Final Thoughts
Effective collaboration between Medical Affairs and Commercial is not only possible—it is
essential to the successful development and commercialization of innovative therapies. The key

is ensuring that collaboration occurs within a governance framework that preserves the
independent scientific role of Medical Affairs.
Companies that invest in thoughtful policies, regular training, documented decision-making, and
proactive legal oversight are better positioned to foster compliant scientific engagement, build
trust with healthcare professionals, and reduce enforcement risk.
As regulatory expectations continue to evolve, organizations should periodically reassess their
Medical Affairs governance structures to ensure they remain aligned with current industry
standards and enforcement trends.
How Kendall PC Can Help
Kendall PC advises pharmaceutical, biotechnology, medical device, and healthcare companies on
the legal and regulatory issues surrounding Medical Affairs, Commercial operations, FDA
promotional compliance, scientific exchange, publications, advisory boards, speaker programs,
healthcare professional interactions, and corporate compliance programs.
Our attorneys work with organizations ranging from emerging life sciences companies entering
the U.S. market to established global manufacturers seeking practical, risk-based compliance
solutions. Whether developing Medical Affairs governance documents, reviewing MSL
operating procedures, conducting compliance training, or advising on complex scientific
exchange issues, our goal is to help clients navigate regulatory expectations while supporting
innovation and responsible commercialization.
Disclaimer: This article is for informational purposes only and does not constitute legal advice.
Organizations should consult qualified legal counsel regarding their specific facts and
circumstances.