On Nov. 12-13, I watched select portions of the live feed from the public hearing titled “Promotion of FDA-Regulated Medical Products Using the Internet and Social Media” in Washington, D.C. Speakers presented almost every 15 minutes and included a wide variety of people, including some from large pharma companies, Google, Yahoo!, PhRMA, and consumer/patient groups. The hearings were prompted after a series of FDA warning letters went out earlier this year notifying 14 drug makers that certain online product ads were misleading because they did not contain any risk information.
Although I felt some of the presentations were a bit too promotional (e.g. PR companies), many of the speakers included statistics and research data that was not only informative, but essential to these discussions. Overall, I’d say my impression was that pharma companies want to be a part of social media but need some guidance in the form of clearer guidelines as to what they can and can’t do and what they will be held responsible for by the FDA. Simply put, we can’t ignore the fact that patients and medical professionals both want and need social media, especially when it comes to AE (adverse event) content. But monitoring (and ultimately being held responsible for) everything online related to a drug’s effect is likely to be a daunting process, so there needs to be some flexibility built in to regulations.
One of the presenters was John Mack, editor of Pharma Marketing News, an active blogger and a social media expert. Mack has been running a survey on his site which contains the 19 questions the FDA wanted the public to answer prior to the hearing. One of those questions addresses the “flexibility” issue. It reads, “Are there different considerations that should be weighed depending on the specific social media platform that is used or based on the intended audience?” In Mack’s survey, 60% of pharma respondents said yes, while 46% of all respondents had the same answer.
Mack believes the FDA should implement “regulatory ‘safe harbors’ under which pharma companies would be relieved of the responsibility of monitoring social media for adverse events.” He also suggests pharma companies turn on the commenting on social media sites like YouTube to encourage a two-way communication. During his final presentation to the FDA panel, he closed with this remark. “This is not your father’s FDA, and I’m hopeful they will come out with guidelines within the next year.”
Social media in the pharma industry is a hot topic these days, which is why we chose to focus on it with this month’s feature article on page 8. (Editor’s note: This article was written in early October, well before the FDA hearing.) If you would like to weigh in on this issue, post a discussion on our Life Science Leader LinkedIn group, send me an email, or DM (direct message) me via Twitter (@LifeSciLeader).