Acronym of the week would be more accurate, but GDUFA will be used as a word so it might as well be defined as one. With the passage of the Food and Drug Administration Safety and Innovation Act on July 9, 2012, GDUFA (‘Generic Drug User Fee Amendments...
by Suzannah Palinkas, Vice President, Group Manager
Recently, Suzannah Palinkas, Vice President,
Healthcare, Washington , D.C., attended the ExL Pharma 5th Annual Digital Pharma East conference in Philadelphia, PA. The following is the first installment in a series of posts inspired by insights gathered at the conference.
“The pirate code is more what you'd call ‘guidelines’ than actual rules.”
– Captain Barbossa, Pirates of the Caribbean
As those of us who are involved in the Pharma industry continue to anticipate the FDA’s social media guidelines, we should think of Captain Barbossa’s differentiation above and ask, “Will guidelines help?” It depends on who you ask, but at the recent ExL Pharma 5th Annual Digital Pharma East conference, many Pharma marketers, communication specialists and social media service providers came to the conclusion that the much-anticipated guidance from the FDA on how to conduct interaction via social media may leave us all scratching our heads, lost in a sea of interpretation.
Since there won’t be finite rules or even laws associated, the guidelines will likely be interpreted within an inch of their lives, with companies finding blurry lines and, more likely, “over-lawyering” as to even further lock the industry into a box of not being able to say a thing about a product – online or elsewhere.
But is this silence right? Should it be okay for a company to talk about what it does and who it helps, as long as it is transparent, honest and truthful?
At the conference, a story was told about a woman who was taking a medication and posted questions on the company’s online public forum, asking about a side effect she was having.. The company removed the post and reported the adverse event to the FDA, but they did not respond directly to the patient. The woman, just looking for an answer, posted to other independent forums to try to find some help and likely received information – true or false – from another patient/caregiver/user. In this case, because the company felt unable to respond given the current uncertainty in this space, it lost control and was unable to provide appropriate, accurate information.
As a long time Pharma communicator, I do believe in what many products can do to help patients. The previous example shows that there is an increasing need, and desire, for two-way conversation in the social media space. Point of fact: Pharma wants and needs to engage in social channels. We’re, just hoping that there will be very clear ‘guidance’ on how.
We capture the opinions and insights of several of our employees on a variety of communication topics about Healthcare.