Medical communications teams must exercise caution when using websites dedicated to medical affairs, as legal risks go beyond overt sales promotion. Drug and device manufacturers face compliance challenges, particularly when these platforms are accessed by broader audiences, including non-scientists.
Key risks include:
- Off-Label Promotion: The Facteau case highlights how communications implying off-label use can lead to violations under the Food, Drug, and Cosmetic Act, even for FDA-cleared devices.
- Improper Audience Targeting: Specialized medical affairs websites are intended for healthcare professionals. If content inadvertently targets patients or the general public, it may be deemed promotional, violating FDA rules.
To mitigate risks, companies should:
- Clearly define intended use and avoid statements endorsing unapproved applications.
- Consider separate patient engagement pages to keep medical affairs content professional and compliant.
- Regularly review communication strategies in light of evolving guidance, such as the CFL and SIUU Guidance, and recent legal decisions like Loper Bright.
The $3 billion GSK settlement underscores the stakes—misbranding, off-label promotion, and audience misalignment can result in severe penalties and reputational harm. Manufacturers should seek expert legal counsel, like the Kulkarni Law Firm, to ensure compliance and safeguard against regulatory risks.
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