At a Glance
Separate from sales conversations, every pharma exhibit booth faces scientific questions from physicians and other clinicians such as APPs (Advanced Practice Providers) and PharmDs that its commercial staff can’t answer. These queries are typically handled by the company’s Medical Affairs team.
Medical Affairs should operate physically and operationally separate from sales, staffed by trained medical professionals, and governed by FDA rules, the PhRMA Code, and OIG guidance.
In this article:
1. Why Medical Affairs Belongs in the Booth
Medical Affairs provides the scientific, non-promotional counterpart to the commercial exhibit. At a medical convention, healthcare professionals (HCPs) often bring questions that exceed approved promotional claims: study design, subgroup data, safety nuances, pipeline science, real-world evidence, or unapproved uses. A clearly identified Medical Affairs area, staffed by trained medical professionals and operationally separated from sales, gives the company a compliant route for addressing legitimate scientific needs. It also supports pharmacovigilance, product-quality reporting, insight gathering, and follow-up after the meeting.
The area should have distinct signage, personnel identification, content, systems, and governance. Commercial staff may direct an HCP to Medical Affairs but should not coach the question, remain to influence the exchange, or use the medical response as a selling tool. Medical personnel should not be compensated on prescriptions, sales, or market share. The purpose is scientific exchange and patient-care support, not demand generation.
2. Legal and Regulatory Guardrails for HCP Interaction
In the United States, booth conduct sits within FDA rules governing prescription-drug promotion and manufacturer communications, the federal Anti-Kickback Statute and related OIG guidance,[1] the PhRMA Code,[2] state laws, privacy requirements, company policies, and convention rules. Promotional claims must be consistent with FDA-approved labeling, truthful, non-misleading, adequately substantiated, and presented with appropriate risk information. Meals, gifts, entertainment, consulting arrangements, and anything of value must never be offered to induce prescribing or referrals.
FDA’s 2011 draft guidance on unsolicited off-label requests[3] remains nonbinding, but it states a durable compliance framework: the request must be genuinely unsolicited; the response should be truthful, accurate, balanced, non-misleading, non-promotional, and narrowly responsive; and specialized medical or scientific personnel should control the response. Sales and marketing personnel should not shape off-label content. Company procedures should also require prompt reporting of adverse events, special situations, and product complaints, regardless of whether the HCP intended to make a report.
3. Booth Engagement and the Medical Information Request Form
The MSL or Medical Information professional should welcome the HCP, identify their role and practice context, listen without leading, and clarify the exact scientific question. The discussion should begin with approved information when it answers the request. If the question concerns an unapproved use, the professional should confirm that it arose independently, explain that the discussion may include information outside approved labeling, and follow the company’s approved response process. Responses should acknowledge limitations, conflicting evidence, and material safety information rather than advocate for a treatment choice.
A Medical Information Request Form (MIRF) is the controlled record of the inquiry and response. Depending on company procedure, it may be electronic or paper and should capture the requester’s identity and contact preference, professional status, date and venue, exact question in the requester’s words, product and topic, whether the request was unsolicited, the materials or verbal response provided, required follow-up, consent/privacy notices, and any adverse-event or product-complaint details routed to the proper function. The HCP’s signature may be required by policy, but the form should not be manipulated into manufacturing an ‘unsolicited’ request.
The MIRF should generate a traceable case number, preserve approved response documents and literature citations, record timely fulfillment, and be retained under records-management rules. Only necessary personal data should be collected. Medical Affairs should trend requests for educational gaps and safety signals, while avoiding use of individual requests as sales leads. Complex questions should be referred to Medical Information for a written, quality-controlled response.
4. The Contemporary Medical Science Liaison
An MSL is a field-based scientific professional within Medical Affairs.[4] Core responsibilities include peer-to-peer exchange with HCPs and scientific experts; communication of clinical, preclinical, real-world, and health-economic evidence; response to medical inquiries; support for investigator-initiated research and clinical-trial feasibility; identification of evidence gaps; collection and synthesis of field insights; education of internal teams; and recognition and reporting of safety or quality information. The MSL is not a sales representative and should be evaluated on scientific quality, stakeholder needs addressed, insight value, research support, and compliant execution – not prescriptions or revenue.[5]
Employers commonly prefer a terminal scientific or clinical degree such as PharmD, PhD, MD/DO, DNP, or other relevant doctorate. Some roles accept master’s-prepared clinicians or scientists – for example, advanced-practice nurses, physician associates, pharmacists, or specialists with exceptional therapeutic-area experience. Acceptability depends on disease complexity, company policy, and the candidate’s ability to appraise evidence and communicate at expert level. Typical experience includes two or more years in clinical care, research, medical affairs, industry, or the therapeutic area; senior roles often require prior MSL experience. Business requirements include territory planning, stakeholder mapping, project management, matrix collaboration, digital fluency, travel readiness, and strong written and verbal communication.
The complexity of the science driving many therapeutic areas requires an ability to understand and present that science to those who can impact the lifecycle of the drug — the Key Opinion Leaders (KOLs). MSLs work to educate and collaborate with KOLs and the broader healthcare provider and payer community of decision makers to ultimately impact patient care and key therapeutic decisions. To do so, MSLs must have expert knowledge of the entire clinical landscape, from treatment guidelines to clinical data and beyond. Therefore, it comes as no surprise that according to The Bowdoin Group,[6] 75% of MSLs have either a PharmD or a PhD, 11% have a Master’s degree and 6% an MD / MBBS.
No US government license or universal credential is legally required merely to hold the MSL title. Clinical licenses must be current when a role requires active practice, but voluntary credentials such as BCMAS or MSL-BC are supplements rather than substitutes for scientific training, therapeutic expertise, company onboarding, and demonstrated competency. Employers should verify degrees and licenses and provide continuing training in product science, evidence appraisal, compliance, pharmacovigilance, privacy, and communication skills.
The phrase ‘learned intermediary’ should be used carefully. In product-liability law, the prescribing clinician — not the MSL — is generally the learned intermediary between manufacturer and patient. The MSL supports that intermediary by supplying accurate, balanced scientific information and clarifying evidence; the MSL does not diagnose, prescribe, replace independent clinical judgment, or become the legal learned intermediary merely by conducting scientific exchange.
5. MSL Workforce Size and Training Pathways
There is no authoritative national registry of MSLs, so a precise US headcount cannot be stated responsibly. However, based on known employment openings and reported statistics from several contract MSL organizations, we estimate there are over 1,200 MSLs in the field in the US with 58.4% of medical science liaisons being women and 41.6% of medical science liaisons being men. Explore more demographic statistics for the MSL workforce.
Formal preparation occurs through employer onboarding, postgraduate fellowships, contract-service organizations, and professional associations. Documented examples include Takeda’s two-year Global Medical Affairs fellowship[7] and the SkinCeuticals-Medical University of South Carolina fellowship,[8] which includes scientific communication, stakeholder engagement, study support, and responses to unsolicited inquiries. IQVIA describes structured MSL recruitment and training,[9] while the MSL Society and ACMA offer onboarding or certification programs. Many large biopharmaceutical companies also maintain proprietary academies, but program names and external availability change; therefore, only publicly documented programs should be represented as open training pathways.
6. Digital MoA Displays in the Medical Affairs Area
Digital mechanism-of-action (MoA) displays can translate complex biology into an interactive scientific narrative. Useful designs allow the MSL to move from disease pathophysiology to target engagement, downstream pathways, expected pharmacologic effects, biomarkers, and unresolved questions. Layered controls can reveal cell types, molecular interactions, time course, or links to approved publications. Captions should distinguish established evidence from hypotheses, identify model systems, display citations, and preserve approved risk and limitation language where applicable.
The MSL should first ask what the HCP wants to understand, then use the display as a visual aid rather than a scripted promotion. The exchange might compare normal and disease-state pathways, pause at a mechanistic uncertainty, or connect a clinical endpoint to the underlying biology. Content must be medically, legally, and regulatorily reviewed; version-controlled; accessible; secure; and configured to prevent unapproved claims, hidden data collection, or unrestricted take-away content. Any off-label discussion should remain request-driven and follow the same MIRF and response procedures as a verbal inquiry.
7. Pipeline Displays for Drugs in Development
Medical Science Liaisons (MSLs) and Medical Information professionals serve an essential role in facilitating scientific exchange with healthcare professionals (HCPs) visiting the Medical Affairs section of a pharmaceutical company exhibit booth. Corporate pipeline displays, whether presented as static graphics or interactive digital touchscreens, provide an overview of the organization’s research portfolio, including investigational compounds in Phase 1, Phase 2, and Phase 3 clinical development, as well as approved products undergoing post-marketing surveillance. Consistent with FDA guidance,[3] the Pharmaceutical Research and Manufacturers of America (PhRMA) Code on Interactions with Healthcare Professionals,[2] and Medical Information Leaders in Europe (MILE) principles, these displays should be educational, factual, balanced, and distinctly non-promotional.
Pipeline displays should clearly identify each compound’s stage of development and prominently disclose that investigational products have not been demonstrated to be safe or effective for any unapproved use and have not received regulatory approval for those uses. MSLs and Medical Information professionals should objectively discuss the scientific rationale, mechanism of action, study design, clinical endpoints, and publicly available clinical data, while avoiding statements that imply efficacy, safety, or the likelihood of future regulatory approval. Any discussion of potential indications should be presented solely within the context of ongoing scientific investigation.
Interactive digital displays can enhance scientific dialogue by allowing HCPs to explore additional information regarding disease biology, biomarkers, clinical trial designs, and emerging evidence. MSLs should guide these discussions using balanced, evidence-based language tailored to the scientific interests of the HCP while responding accurately and transparently to unsolicited scientific questions. Medical Information professionals should provide appropriate references, approved scientific response documents when available, and follow-up for complex inquiries.
To preserve the distinction between scientific exchange and product promotion, the Medical Affairs area of the exhibit booth should be physically and operationally separate from promotional exhibits, with appropriately trained personnel conducting all interactions. Pipeline displays should include clear disclaimers identifying investigational compounds and distinguishing them from approved products. By adhering to FDA expectations, the PhRMA Code, and MILE principles, Medical Affairs professionals can promote credible, scientifically rigorous, and compliant engagement with HCPs while supporting informed discussions regarding the future of therapeutic innovation.
8. Running and Evaluating the Medical Affairs Booth
A well-run Medical Affairs booth protects scientific integrity by combining physical separation, trained personnel, approved content, disciplined documentation, prompt safety escalation, and meaningful follow-up. Pre-convention training should include role-play, escalation pathways, adverse-event scenarios, privacy, MIRF completion, and rules for digital content. Post-convention review should assess response quality, fulfillment time, recurring evidence gaps, and compliance observations – never sales conversion.
Frequently Asked Questions
Commercial staff present approved promotional claims. Medical Affairs provides the scientific, non-promotional counterpart — answering HCP questions that exceed approved claims, such as study design, subgroup data, safety nuances, pipeline science, and unapproved uses. The two should be physically and operationally separate, with distinct signage, personnel identification, content, systems, and governance, and commercial staff should never coach the question or use the medical response as a selling tool.
FDA rules on prescription-drug promotion and manufacturer communications, the federal Anti-Kickback Statute and related OIG guidance, the PhRMA Code on Interactions with Healthcare Professionals, state laws, privacy requirements, company policies, and convention rules. Promotional claims must be consistent with FDA-approved labeling, and nothing of value may be offered to induce prescribing or referrals.
Only through Medical Affairs, and only when the request is genuinely unsolicited. Under FDA’s 2011 draft guidance, the response should be truthful, accurate, balanced, non-misleading, non-promotional, and narrowly responsive, and specialized medical or scientific personnel should control it. Sales and marketing personnel should not shape off-label content.
A MIRF is the controlled record of an HCP’s scientific inquiry and the company’s response. It captures the requester’s identity and contact preference, professional status, date and venue, the exact question in the requester’s words, product and topic, whether the request was unsolicited, what was provided, required follow-up, consent and privacy notices, and any adverse-event or product-complaint details. It generates a traceable case number and is retained under records-management rules. It should never be used to manufacture an “unsolicited” request or as a sales lead.
An MSL is a field-based scientific professional within Medical Affairs. At a conference, MSLs conduct peer-to-peer scientific exchange with HCPs, respond to medical inquiries, communicate clinical and real-world evidence, identify evidence gaps, collect field insights, and recognize and report safety or quality information. They are not sales representatives and should not be evaluated on prescriptions or revenue.
No. In product-liability law, the prescribing clinician — not the MSL — is generally the learned intermediary between manufacturer and patient. The MSL supports that intermediary by supplying accurate, balanced scientific information; the MSL does not diagnose, prescribe, replace independent clinical judgment, or become the legal learned intermediary by conducting scientific exchange.
Employers commonly prefer a terminal scientific or clinical degree — PharmD, PhD, MD/DO, DNP, or another relevant doctorate — though some roles accept master’s-prepared clinicians or scientists with exceptional therapeutic-area experience. Typical experience is two or more years in clinical care, research, medical affairs, industry, or the therapeutic area. No US government license is required to hold the MSL title; voluntary credentials such as BCMAS or MSL-BC supplement rather than replace scientific training and company onboarding.
There is no authoritative national registry, so a precise headcount cannot be stated responsibly. Based on employment openings and reported statistics from contract MSL organizations, the article estimates more than 1,200 MSLs in the US, with 58.4% women and 41.6% men.
Yes, within the Medical Affairs area, when the display functions as a visual aid rather than a scripted promotional tool. The MSL should first ask what the HCP wants to understand, then use the display to support that specific conversation — moving from disease pathophysiology to target engagement, downstream pathways, and unresolved questions as relevant. Captions must distinguish established evidence from hypotheses, identify model systems, and display citations. Content should be medically, legally, and regulatorily reviewed, version-controlled, and configured to prevent unapproved claims or unrestricted take-away content. Any off-label discussion prompted by the display should follow the same MIRF and response procedures as a verbal inquiry.
Yes, in the Medical Affairs area, if the display is educational, factual, balanced, and non-promotional. It should identify each compound’s stage of development and disclose that investigational products have not been demonstrated safe or effective for unapproved uses. MSLs should discuss scientific rationale, mechanism, study design, and publicly available data while avoiding statements that imply efficacy, safety, or the likelihood of regulatory approval.
On response quality, fulfillment time, recurring evidence gaps, and compliance observations — never on sales conversion. Medical Affairs should trend requests for educational gaps and safety signals while avoiding use of individual requests as sales leads.
References
- HHS Office of Inspector General. Compliance Program Guidance for Pharmaceutical Manufacturers. Federal Register. 2003;68:23731-23743.
- PhRMA. Code on Interactions With Health Care Professionals.
- US Food and Drug Administration. Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices (Draft Guidance, 2011).
- Medical Science Liaison Society. What Is a Medical Science Liaison?
- Measuring the Impact of Medical Science Liaisons: A Global Cross-Sectional Survey of Evaluation Practices and Perceptions.
- The Bowdoin Group. Infographic: Hiring Medical Science Liaisons.
- Takeda. Global Medical Affairs Fellowship.
- Medical University of South Carolina College of Pharmacy. SkinCeuticals Medical Affairs Fellowship.
- IQVIA. Medical Science Liaisons: A Key to Driving Patient Access to New Therapies.
About the Author
Michael W. Young is the principal healthcare strategist for Sparks. He leads biomedwoRx: Life Sciences Consulting, a strategic advisory firm working at the intersection of clinical strategy and commercialization for biotechnology, pharmaceutical, diagnostic, medical-device, and clinical-software organizations worldwide. He has received several industry and association awards and brings more than two decades of biopharmaceutical leadership experience, including senior commercial roles at Eisai, Ligand Pharmaceuticals, GSK, Bayer, PPD, PAREXEL, and Klick Health. Michael also serves as a board director for HCEA, the Healthcare Convention and Exhibitors Association.
