The 5Ws of Managing Advertising and Promotion Risk
April 26, 2021—Does this need MRL review? It’s among the most frequent questions I field from clients. My response is nearly always the same. It’s an unsatisfying, it depends on the 5Ws—who, what, when, where, why, and how.
The Federal Food, Drug, and Cosmetic Act (FDCA) gives the US Food and Drug Administration (FDA), among other things, the power to regulate promotional content for drugs and some medical devices. It contains 23 requirements for written materials.
If these conditions aren’t met, a company risks FDA finding this it has “misbranded” the product. The two most common transgressions occur when the agency determines a piece is either “false or misleading” and/or lacks “adequate directions for use” of the product in violation of §§ 352(a) and (f). A host of FDA enforcement action examples appear on its website.
It seems like manufacturers could avoid infractions by creating a simple promotional materials checklist to ensure compliance. If only it were that easy. There's no bright line that companies can universally apply. The trick is every communication needs to be considered in the context of its usage, making compliance far more an art than a science.
Short of a Medical-Regulatory-Legal (MRL) team reviewing every single communication prior to use, companies opt for a risk-based approach. First, they train company-wide on the general requirements for product promotion. Then, they review only those materials with the greatest likelihood of being promotional—for example, anything used externally by Sales, Marketing, or Medical Affairs.
While each company’s process differs, they generally aim to navigate the same questions:
- WHO: To whom is the piece directed? Prescribers? Patients? Neither?
- WHAT: What is it about? Announcing a new study? A recent formulary change?
- WHEN: Is this before or after FDA marketing authorization? For this particular usage?
- WHERE: Will the piece be used with a US audience? In a publication? At a trade show?
- WHY: Is the communication proactive or reactive? If reactive, is it a narrow response?
- HOW: Is the tone promotional in nature? Are the content and design similar to other promotional materials (e.g. logos, uses product brand name, coloring, layout)?
Industry best practice dictates manufacturers have a policy or procedure that sets out their approach to managing advertising and promotion. While not eliminating risk entirely, a standard method can drive compliance. It can go a long way toward achieving alignment across all functions that create external content for use with customers.
Need help drafting a policy? Want to tune up your existing procedure? Contact Razor Legal Solutions here. We’d be glad to assist.
This alert provides information as a service to clients and other friends of the firm for educational purposes only. It should not be construed or relied upon as legal advice, and it does not create an attorney-client relationship. © 2021 Razor Legal Solutions. All rights reserved.