…BUT HEALTHCARE MARKETERS ARE LEFT WANTING FOR REGULATORY GUIDANCE. 

Jim Mittler, PhD, Medical Director (@jim_mittler)

On December 30, 2011, the United States Food and Drug Administration (FDA) released new draft guidance for the pharmaceutical industry entitled Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices. There has been a lot of chatter in the pharma social media community that these new guidelines are the social media regulatory guidance the industry has been asking for. While the new guidance does touch on social media, it is primarily focused on responding to unsolicited requests for off-label information. Actionable social media guidance from the FDA was not provided despite being heralded as such in many recent news articles and blog posts. A few examples:

• Translating the New FDA Social Media Guidance
• FDA Draft Guidance Offers Social Media Insight
• FDA issues draft social-media marketing guidelines

The headlines are a bit misleading, perhaps because there has been much anticipation for genuine social media guidance for digital promotional activities nearly 2 years after the FDA public hearing on social media in the pharma industry.

FDA recognizes that it’s in the best interest of public health that pharma companies provide off-label information because they maintain the most comprehensive body of scientific information about drug or device. Off-label promotion is clearly a violation of regulatory statutes and the new draft guidance doesn’t change or allow any actions much different than those previously allowed; ie, medical affairs personnel can engage in the scientific exchange of drug/device information for currently unapproved uses as long as the company does not prompt the consumer in any way and the response is truthful, balanced, and nonpromotional in nature. The consumer question must be “unsolicited” and the response must be specifically directed at the person who made the request.

(Please see the SlideShare presentation, Off-label Information on Prescription Drugs and Medical Devices in the Era of Social Media, for more information.)

In the past, request for off-label information likely came from a physician and occurred during a meeting with a sales rep (nonpublic request) or at a company-sponsored live presentation (public request). Now that consumers are deeply engaged in the digital world, publicly asked questions about the use of a drug or device can arise from anyone using any number of digital platforms; ie, Facebook, Twitter, blogs, discussion boards, etc.

If a company chooses to respond to an off-label request for information through digital media, the response must be limited to the company’s contact information and providing a direct hyperlink to FDA-approved label (not a branded Web site). Any public response that contains specific off-label information is considered promotion because it would not be specifically directed at the person who made the request for off-label information. While these are the regulations the industry must play by, this privatizes the communication stream and opposes the basic tenet of social media – the open and interactive sharing of information.

There are several key insights on the use of social media by pharmaceutical companies that can be found in the draft FDA guidance:

• An understanding on the part of the FDA that the Web has revolutionized communication
• The FDA acknowledges the value of social media, which makes it easy to find health-related information and treatments
• But social media tools can spawn digital content that is published by people who are not affiliated with the pharma company. Potentially erroneous or dated information could be spread

A response to an unsolicited off-label request for information can be made through digital channels, but because of the limited response allowable under these draft guidelines, the “social” aspect of social media fails. So it seems like it is business as usual for pharma… we’re left wanting for FDA guidance on the use of social media for the promotion of on-label uses for drugs and devices.

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