DarshanTalks Podcast
Welcome to DarshanTalks!
We demystify fraud for legal, regulatory, and compliance essentials in the life sciences and pharmacy industries. Through engaging 15-30-minute interviews with influential change makers, short educational regulatory defbriefs, and 60 second audio takeaways, we unveil the strategies behind bringing drugs and devices to market—and keeping them there!
Powered By The Kulkarni Law Firm - Helping regulators see your business the way you do.
We focus on life science issues involving medical affairs, marketing and advertising, and clinical research so that you can learn about the industry, enhance your business and grow your career.
DarshanTalks Podcast
Is Your Medical Website Illegal?
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.
