Defining Medical Affairs and Commercial Roles

Industry colleagues are particularly focused on understanding the distinction between Medical and Commercial communications. This is partly driven by time-pressured HCPs seeking more scientific value from their engagements with pharma and Medical Technology (MedTech) companies. At times, they prefer peer-to-peer interactions, such as scientific exchange with Medical Science Liasions (MSLs) or Medical Affairs professionals, instead of traditional meetings with sales reps.

Despite Commercial teams still receiving the bulk of communications budgets, HCPs’ preference for Scientific Exchange with Medical Affairs colleagues has resulted in emerging trends across the industry. These include an increase in the number of MSLs partly because many healthcare organizations are limiting sales reps’ access to clinicians. Additionally, Commercial teams are working to incorporate meaningful value-added offerings, such as educational materials, to engage busy HCPs under elevated time pressures, especially since the COVID-19 pandemic.

One such trend has been that disease awareness education has become increasingly the remit of Medical Affairs, whereas traditionally, it fell to marketing. Subsequently, there is a need to clarify what is permissible for Medical Affairs professionals to discuss instead of Commercial colleagues.

This includes discerning the boundaries within Medical Affairs communications, such as differentiating between product-specific education and disease-related information and whether these topics can be addressed concurrently. FDA guidance informs us that disease awareness communications are communications disseminated to consumers or HCPs that discuss a particular disease or health condition but do not mention any specific drug or device. They also do not make any representation or suggestion concerning a particular drug or device. (6)

Much of the existing uncertainty stems from varying perceptions of risk. If there were clearer distinctions and guidelines regarding what constitutes branded versus unbranded content, promotional versus non-promotional material, and the appropriate combination of these elements, it would assist the industry in determining what can and cannot be communicated and what the guardrails are regarding review and approval of such content. Enhanced clarity in these areas would help not only in compliance but also in strategizing effective communication methods within the industry.

Compliant Cross-Functional Collaboration in an Omnichannel World

Cross-functional planning has become essential to ensure adherence to regulatory and compliance requirements and carefully observe the growing potential for overlap between Commercial and Medical Affairs, thereby remaining compliant. The more activities are integrated, the more challenging it becomes to convince regulatory bodies like the FDA or the Department of Justice of their distinctiveness.

This is especially important when it comes to activities that Medical Affairs should deal with alone, according to Jessica Ringel, a partner at King & Spalding law firm specializing in FDA regulations. She advises clients to be aware that regulators assess organizational activity as a whole rather than the activities of isolated functions, teams, or activities.

If Commercial and Medical Affairs teams are using the same communication channel, producing a large volume of content, it could lead to regulatory concerns due to the creation of an “echo chamber” effect.

“If you’re communicating off-label uses, such as different dosing regimens—if we’re talking about pharma—or an emerging procedure—if we’re talking about devices—even if the Medical Affairs department is leading the communications, a regulatory agency such as the FDA may still look at the activity skeptically,” says Ringel, explaining that a regulator will consider the totality of activities from across an organization to determine whether to deem the intent behind communications on an off-label topic as promotional or non-promotional.

This necessitates new responsibilities, such as coordinating with Commercial counterparts. It is essential to ensure that when one team is active on a channel, the other is not. It may be necessary to decide to use only a specific channel that the other team does not use, leading to strategic discussions.  The level of coordination between Commercial and Medical remains an area of risk, and each company may choose to set different limitations.

Overview of Off-Label Communication Safe Harbors

The FDA recognizes the importance of being able to communicate non-promotional information about unapproved uses of existing therapies that have not yet been through the regulatory pathway. New draft guidance from the FDA on disseminating scientific information, revised and published in October 2023, has expanded to cover industry-produced presentations of scientific data from published reprints and independent clinical practice resources. This scope goes beyond its initial focus on distributing scientific or medical journal articles, reference texts, and clinical practice guidelines. Additionally, it features an updated format, including questions and answers. However, uncertainty and challenges remain.

FDA guidance details various “Safe Harbors” under which the dissemination of scientific information will be considered non-promotional:

1. Off-label and pre-approval communications with payers

FDA guidance finalized in 2018 permits communications with payers and purchasing decision-makers regarding off-label uses of marketed products and for investigational drugs and devices not yet approved for Commercial sale but expected to be within approximately six months, in recognition of payers’ and purchasers’ need to plan for coverage and purchasing far in advance of regulatory authorization. Significant delays can ensue if discussions with committees are postponed until FDA approval or clearance is granted. This results in the inability to provide these drugs or devices to patients immediately upon approval or clearance due to the lengthy procedural lead times these committees face. Thus, this guidance permits earlier communications with decision-makers about investigational drugs or devices and off-label uses of drugs and devices already on the market. (7)

2. Handling unsolicited requests for information about off-label usage

The FDA’s guidance emphasizes the importance of properly managing unsolicited inquiries from doctors regarding off-label product use. It focuses on ensuring these inquiries are genuinely unsolicited to prevent companies from subtly promoting products. Organizations can respond if a request is unsolicited, but the guidance specifies that Medical, not Commercial, teams should prepare responses. These responses must be factual and non-promotional, and directly address the specific question asked. The FDA distinguishes between private (e.g., during sales visits or via direct communication) and public (e.g., social media, symposia) inquiries, advising that public questions be redirected to private channels for response. This approach aims to ensure that reactive dissemination of off-label information does not create a new intended use for the drug or device and to maintain the integrity of information dissemination. (8)

3. Disseminating scientific information on unapproved uses of cleared/approved products

Examples include peer-reviewed scientific journal reprints and clinical references. As mentioned, in October 2023, the FDA revised the draft guidance on distributing scientific information on unapproved uses, expanding communications beyond scientific reprints to include how an organization presents and disseminates off-label information from reprints. Company representatives can actively distribute references and company-generated presentations of information from within the scientific references, provided they adhere to specific criteria for selecting suitable reprints and publications. The presented information must be based on solid, peer-reviewed science and comply with numerous other rules. Furthermore, there are guidelines on presenting this information, such as including the FDA-approved label and information regarding conclusions from other studies that are contrary to, or cast doubt on, the presented information. (9)

4. Off-label and pre-approval IME content

Regardless of whether an IME session focuses on off-label or investigational uses of an organization’s drug or device or discusses a disease state that includes off-label or investigational treatments, the creators of IME may approach the manufacturer for funding through an educational grant.  According to guidance, an organization can financially support such a session and be listed as a Commercial supporter. However, the Commercial supporter must maintain complete independence from the IME’s content and organization beyond providing funds. This means a manufacturer must not be involved in selecting speakers or any aspect of planning and implementation—these responsibilities fall to the IME provider. Additionally, the company must not review or influence the educational materials, such as slides.  Adhering to these guidelines ensures that the organization’s involvement is limited to financial support and does not cross into inappropriate off-label promotion, per FDA regulations. (10)

Company Strategic Priorities: Evidence Dissemination, Scientific Exchange, and Education

Medical Affairs teams are adept at integrating distinct facets of scientific discourse, including clinical and Commercial topics, into a unified discussion. They often lead these discussions, which can take various forms, establishing Medical Affairs as key facilitators in driving Scientific Exchange and dialogues. While Medical Affairs takes the lead, Commercial teams and other departments may also participate in scientific discussions with HCPs, especially on topics that are within the approved product use (on-label) or during advisory boards, where there is a chance to explore broader topics like new ideas, study results and impact, and products.

Each Medical Affairs function within a company partakes in differing aspects of HCP omnichannel engagement, tailored to align with the organization’s strategic priorities. The goal of External Education activities—whether led by the company or supported independently—is to enhance the knowledge and skills of HCPs, instill attitudes and beliefs that foster behavioral change, and elevate clinical practice, ultimately benefiting patient outcomes beyond the confines of the company’s assets.

In today’s rapidly evolving information landscape, where new data constantly emerge, it is essential to develop processes and tools to monitor such data continuously. This approach demands a more agile and responsive strategy to keep pace with the continuously changing data landscape. It enables frequent updating and refining of scientific narratives to reflect the most recent information.

Evidence dissemination could be considered the first step in communicating scientific information, intending to build awareness and knowledge. The channels involved include publications, medical communications with HCPs, and medical information disseminated widely through journals, congresses, social media posts, and websites.

Scientific Exchange encompasses an active, unbiased dialogue and exchange of medical information, with an overarching goal beyond merely clarifying and answering queries. It aims to foster a deep understanding and build confidence among interested parties in specific scientific information. This is achieved through education and training, encompassing discussions on disease states, pathophysiology, procedural and surgical techniques, complications, best practices, and guidelines.

Active channels that provide an opportunity for recipients to ask questions and engage in dialogue, such as during training with an educator in real time, symposia, webinars, and MSL-led events, but could also include emails triggered by medical requests for information, interactive educational apps, or information on pipeline investigational compounds.

Notably, regulators consider the number of programs when assessing whether communications can be classed as Scientific Exchange and will also evaluate whether communication is too frequent or no longer “novel.”

External Education could be considered the training and content needed to enable HCPs to gain and use new skills within clinical practice and share or advocate for them within their respective care teams, as shown in Figure 5.