Pharmas: Cry-babies, social media resisters or victims of unclear regulatory guidance?
Without explanation beyond encouraging “an authentic dialogue,” Facebook has reversed a policy that allowed pharmaceutical companies proactively moderate wall comments, deciding which they would move forward and which they would delete. As a result, several pharmas—Astra Zeneca, for example, and Bayer. Others, like Amgen, suspended their plans to introduce pages.
The change does not apply to product-specific pages, but it does affect pages dedicated to conditions. In other words, a company making a diabetic drug can still proactively moderate comments on the page for the drug, but not on its page about “Healthy Living with Diabetes.”
Most commentary has praised Facebook for the move, arguing that it’s time for the pharmas to grow up already and start engaging. On Read Write web, Marshall Kirkpatrick wrote argues that the rationale expressed by the pharmas for open customer engagement is a chimera: is a chimera; the real reason is “because Facebook Pages are an officially sanctioned communication channel. And crazy complainers ought to be kept from clean, well-lit official places if that’s an option.”
Peter Pitts, former FDA associate commissioner and president of the Center for Medicine in the Public Interest, thinks pharmas a crying a little too loud, arguing that the essence of social media is engagement, and pharmas just don’t want to engage.
To suggest that “Big Pharma” is one giant clan of conspiring organizations is naieve. These are competitors and, as in any industry, each company has its own set of values and its own culture. (In the early 1990s, I was director of corporate communications for Allergan, and I can tell you with certainty that we were not all buddy-buddy with Bausch & Lomb, our biggest direct competitor, any more than Mattel and Hasbro made goo-goo eyes at each other.)
More and more, pharmaceutical marketing has been directed at the patient, not the prescribing physician. Docs are getting downright frustrated by patients demanding a drug they’ve seen on TV or the Net, despite the fact that the MD is aware of other factors that would argue for a different treatment. If pharmas can engage patients on Facebook leading to more scrips for their product, they’d be all over the medium. Many have started blogs—where they can proactively moderate out the comments that can cause regulatory headaches.
One thing pharmas do have in common, though, is the regulations by which they must abide. And these regulations have not kept up with the pace of change in social media.
At the heart of pharma’s jitters over Facebook is a report of an “adverse effect.” When made to the company (as opposed to a friend, a personal blog or a third-party forum), these must be reported to the U.S. Food and Drug Administration. Moderating doesn’t help. A community manager can remove a comment in a heartbeat after it was posted. The mere fact that it was posted publicly is enough to trigger the need to report.
There has been no shortage of critics of this argument. First of all, people don’t want to use Facebook to report adverse effects, the critics say, further noting that the criteria required for an adverse effect to be reportable are rarely met online.
I suspect, though, that the critics don’t dig much deeper into the business realities that pharmas face. According to Chris la folla, writing last April in Pharma for PR:
For the safety departments at pharmaceutical companies, the fears of adverse event reporting were never about “reportable” AEs, they were about acknowledging the realities of their job function. That reality means the safety department has to handle all possible AEs that come in through social media channels, not just the ones that are reportable. This is where the overwhelming burden starts to become tough to manage. As the engagement goes up, so does the frequencies of “possible” AEs.
la folla notes that pharmas don’t want to stick their fingers in their ears and chant “na na na na na, I can’t hear you” over reports of adverse effects. Like most businesses, they want to make products that actually work well. And the FDA has long promised guidance on social media, issuing deadlines by which they would issue that guidance. Those deadlines have come and gone more than once without barely a whisper from the FDA. On PharmExec.com, Thomas L. Harrison notes, “The current rule-making process may be somewhat less precise and prescriptive than many people think -– or hope.”
Harrison suggests the smart companies will have figured out how to appropriate resource for the burden of monitoring comments that present regulatory risk (which also cover discussion of unapproved uses of drugs, among other things). Indeed, a few companies are holding their breaths and increasing the vigilance of their reactive monitoring efforts.
But unless you’ve sat in on the budget discussions for safety departments, it’s way too easy to sit back and say, “Social media is for real and they need to budget for it.” In this heavily a regulated industry—with different but equally onerous regulations in every country—it’s not the same as Delta Airlines setting up a Delta Assist Twitter account for passengers encountering travel difficulties.
Of course, pharmas can generate tremendous benefits from engagement. It’s not a reluctance to engage that has Johnson & Johnson and others closing down their pages. It’s vague regulations and lack of guidance. The finger is being pointed in the wrong direction.
“Instead of trying to convince companies that the AE reporting burden doesn’t exist,” la folla wrote, “let’s shift our attention to figuring out how to mitigate that burden most effectively.”
Note—I’m reaching out to several experts to have a discussion about this issue in an FIR interview. I’ll let you know when it happens.
08/17/11 | 2 Comments | Pharmas: Cry-babies, social media resisters or victims of unclear regulatory guidance?