Are you Getting Ready for the FDA’s Big Pharma Social Media Rules?

Many pharmaceutical companies (including those selling prescription drugs for humans and animals, prescription biologics, and medical devices) are now starting to use social media in their general marketing and to communicate directly to customers.

The industry as a whole—similar to other highly-regulated groups, like financial services—has approached social media with caution, while it waits for more social media guidance from the U.S. Food and Drug Administration (FDA).

Very soon, that day of clarified guidelines will be here. The FDA has issued three draft social media guidance documents this year, and made them available for industry commentary. It’s expected the final guidance will be released any day now.

Common Themes in FDA Social Media Guidance

Throughout all three documents, it’s clear the FDA wants pharma companies to know social media communications need to be balanced, fair and not misleading to consumers. Also, a firm is ultimately responsible for the content it creates and shares.

In addition, information about a product or service’s risk must also be featured prominently alongside product benefits, regardless of the space constraints inherent with social media. For instance, any social media message, post, or tweet must include a direct hyperlink to product risk information and/or FDA labeling so people can learn more about the product.

Another core theme is that firms must capture and preserve full and proper records of their social media communications. These need to be retained, preferably in context, in a format that preserves interactive links and full metadata, including the author and date of a social post or message.

Preparing for Increased Social Media

It’s fair to expect that when the FDA finalizes its guidance the standard to which pharma companies are held for social media will be higher and firms will be scrutinized more. On the plus side, the clarified social media parameters might help firms that held back from social begin to increase their brand awareness, customer and partner interaction, and sales on social networks.

Until the guidance is finalized, the best thing your company can do is determine to what extent your company is or would like to use social media, supervise its use within your company, and develop social media and interactive website use policies that are in line with current FDA draft guidance, along with other applicable regulations.

Next, investigate technologies that can help your company retain and review social media and interactive website content. These solutions will allow you to prepare for the final rules provided by the FDA.

The FDA draft social media guidelines
January 2014

• Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics

June 2014:

• FDA Draft Guidance for Industry Internet/Social Media Platforms with Character Space Limitations—Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices
• FDA Draft Guidance for Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices
• The FDA has also developed ‘The Social Media Draft Guidance Webinar’ which is available on its website for companies that would like more information.