FDA Guideline Talk Starting to Boil

We need more data and smarter ways of acting on it. As healthcare reform changes begin to take hold, we will all be operating in an increasingly outcomes-driven environment.  Doctors will need to more closely monitor their patients, yet they still lack tools for using that data to inform more personalized dialogue with patients. 

The pharma industry has an opportunity to deliver meaningful support to the success of this new patient-centric model.  Not through direct-to-patient programs, or a product-centered Facebook page, but rather by providing a platform for the communication loop between providers and patients.  

Prompted by widespread expectations and anticipation that the FDA may issue guidelines in the next several weeks for the use of social media by pharmaceutical and medical device companies, last week the New England Journal of Medicine released an article titled, “Pharmaceutical Marketing and the New Social Media” by Drs. Jeremy A. Greene and Aaron S. Kesselheim of Brigham and Women’s Hospital in Boston. 

Though the article states that at least 60% of Americans turn to the Internet first when seeking health information, Drs. Greene and Kesselheim argue that physicians should still be wary of Internet-based promotional activities for three reasons:

• Lack of research on the health impact of such communications
• Difficulty in establishing the credibility of information produced by entities with a financial interest in its use
• Lack of mechanisms that hold the FDA and drug companies responsible for maintaining the credibility of the information

None of these points seem surprising, nor new. The “Wild West” of social media does not meld easily with pharma, whether it be in intention or execution. It’s a space that’s going to continue to face growing pains, even with a new set of FDA guidance.

That’s not to degrade this topic as there is no lack of interest in the issue. Last November more than 800 people signed up to attend two days of public meetings convened by the FDA, to brainstorm guidelines for the appropriate use of social media by pharmaceutical companies.

The reality is that we’re here now, a year later with the same concerns, same road blocks with social media. What I would like to see is more of a laser focus on building digital platforms that embed physicians in the equation, enabling more personalized and secure interaction with patients. If the right platforms don’t exist, let’s create them.

Whether the FDA gives guidance that is for or against social media use, the existing social platforms cut out one of the biggest stakeholders in this whole equation: the physician.

Welcome comments below.

Best,

Gene Guselli