New Developments in Pharma/FDA Faceoff

Nina Dunn's picture

The pharmaceutical industry realizes it must participate in social media. After all, that’s where its customers — patients and health care providers — can be found. In fact, more than 65 percent of physicians use social media for professional purposes, while more than 40 percent of patients use it to find health-related information.

However, despite these numbers, many pharma-communications professionals have taken a wait-and-see attitude because FDA rules regarding social media engagement still remain unclear.
The good news is that the FDA is growing accustomed to social media use. Last December, the agency released its first draft guidance on Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices.
Now, those of you who expected to see a fully outlined document will probably be disappointed. The document didn’t come close to answering all the questions that we have in the medical-marketing field.
But it was a good start. I was especially pleased to see the FDA using examples to illustrate its guidelines in several situations, giving us a better understanding of the agency’s judgment on the use of “emerging electronic media” (as it was called in the draft).
We can expect that the FDA will continue to dribble out narrowly focused drafts on social media use by pharma. That’s because social media is still a new and evolving medium, and the FDA doesn’t want to get too specific in order to make sure that its guidelines will remain relevant in years to come.
Also, the agency’s concern with social media has nothing to with marketing needs, but rather what can advance public health.
This is where a recent study by Manhattan Research offers a bit of sunshine. It turns out that 42 percent of Americans would like to see pharma actively engaged in online health communities. This is especially true for caregivers of ADD/ADHD and bipolar disorder patients.
This new study validates the argument that pharma’s participation in online communities is often beneficial to patients and that Americans favor such involvement. Hopefully, these findings will encourage the FDA to pick up the pace and address the issues of space limitations, adverse event reporting, the use of links and others in the near future.
Nina Dunn is an account director and media specialist at Spector & Associates. In her current role, Nina works with the agency’s healthcare and technology clients, helping them develop effective thought leadership campaigns and communications strategies. You can reach her at or follow her @Spector_Health.