In Regulatory Wrap for the week to October 3, Ryan Thaxton explores the growing spotlight on pharma companies’ social media activity.
In this week’s Regulatory Wrap, we dissect the Food and Drug Administration’s (FDA) enforcement action against pharmaceutical companies direct-to-consumer advertising, which includes 100 cease and desist letters for misleading advertisements.
1. The FDA has issued 100 cease and desist letters requiring that pharma companies immediately pull advertisements found to be false or misleading, as well as issued warning letters for less severe infractions
2. The FDA has underlined social media channels as an area of concern and stated that influencer’s sponsor posts failed to display sufficient risk information
3. A pharma CEO was criticized for sharing an Instagram story on her personal account, which was deemed to be “promotional in nature” and lacked necessary information
4. Larger pharma companies have begun to assess risk and strengthen compliance workflows, and to protect against fines and reputation damage, smaller organizations must follow suit
5. To keep aligned with regulatory requirements like the FDA’s CFR Title 21, pharma companies should put policies in place to capture and archive social media activity, which allows teams to review for risks like off-label claims or omissions
This week’s Regulatory Wrap is brought to you by Global Relay’s ABM Content Writer, Ryan Thaxton.
With the FDA emphasizing expectations around compliant advertising and advising companies that more action is likely to come, those who proactively supervise social media marketing risk will be better equipped to handle regulatory scrutiny.
