For some time, the pharmaceutical industry has been wondering around the social media space with a blindfold on. With no guidance, and no indication of any position whatsoever, FDAs DDMAC has let each medical products take their chances in the social media space, occasionally enunciating policy by issuing untitled letters rather than proactively laying out some of the do's and dont's of social media in general, and twitter in particular.
Is the mention of a drug by a company in the context of a tweet considered a reminder ad? Would it garner an untitled or warning letter, because the risk information is not there in the tweet? Or is it more akin to the verbal mention of a drug by a sales representative in a booth at a medical meeting? Which is it? We don't know. DDMAC has never said. They will only say it is the message, not the medium, a statement that, in this context, means virtually nothing.
Yet on September 11, the FDA put up a page on its Web site announcing it's own foray into Twitter. The Twitter site already has over 1500 followers. Is what is good for the FDA goose now good for the industry gander? Again, we don't know.
There are a growing number of medical product companies now on Twitter. Some use it as a listening post, some as a means of issuing press releases or notices without specific drug mentions. Some have been brave souls and mentioned a drug name in a Tweet. The fact that they may not have yet received a violation notice from the FDA probably doesn't tell us much since it takes the agency a good long while to generate those letters.
Per FDA law expert Arnie Friede of Arnold I Fried & Associates in New York, this is a "serious incongruity. FDA is now disseminating its own information on Twitter yet has not adopted a discrete policy on how manufacturers and other regulated entities may use Twitter and other social media to send comparable messages. There is something seriously wrong and uneven with this picture. It adds gravitas to the arguments on the need for a discrete FDA policy on social media…"
Well said. Arnie points further to the comments recently filed by the Competitive Enterprise Institute in response to the FDA's draft guidance on risk disclosure in regulated advertising and promotion.
I have taken a couple of days to check over the Twitter stream coming out of FDA. They don’t seem to reply to- or establish any comment on other people’s twits. So I don’t think that your criticism of FDA for having this communication line is entirely on base. You want FDA to create guidelines governing two-way online conversations via Twitter and other social marketing programs. (I actually agree that FDA could draft guidelines clarifying some of the confusion.) However, FDA isn’t using Twitter for two-way conversations. It’s more of a 140 character-limited blog post.
Another key distinction is that pharma companies would be using twitter to market their products, which is itself a highly regulated activity; whereas the FDA twitter is notifying the public of approvals, label changes, etc., but is not promoting products. They seem like entirely different activities to me.
Oh Pierce, you and I are always star crossed. If the FDA says that a
product is approved, and the company says a product approved and it is the
same message, what is the difference? How can news about a company be
different from news from a company. News is news.
On Wed, Sep 16, 2009 at 12:39 PM, wrote:
Actually, I really enjoy your blog and find it to be very useful reading.
You really don’t think it’s different when the FDA reports on a drug approval versus when the manufacturer reports on it? The FDA and the manufacturer will be using the same language, for the same audiences, including the same links? Will the manufacturer also be twittering to let us know when they have to strengthen the warning on their label, or when their competitor’s product is approved or when a generic becomes available? I’m sure you know that it’s not just what you say, but how you say it, that matters.
I see your point and agree that the FDA should be able to give guidance on this issue. But I think you have to agree that a drug manufacturer and the FDA are going to differ in many respects in what they want to communicate, why, and how.
You are right. They are different and I do think there should be standards
for pharma communications via Twitter and other digital communications. But
if they are both announcing an approval, I don’t think they are different.
My point is – it is the message not the medium is insufficient – and I
think that our discussion proves that. DDMAC needs to get off the dime.
I’m glad you like the blog. I like your comments too and always respond
when I have the time, which lately has been spare! Best, Mark
On Wed, Sep 16, 2009 at 3:04 PM, wrote: