Is it Time for the FDA to Chime in on Drug Company Tweets?

5/26/10

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been tweeting on behalf of the company since 2009, but says he mostly focuses on corporate initiatives, staying away from particular product information.

Vertex Pharmaceuticals, which officially opened its Twitter account last week, is not discussing its development program via Twitter and is for now seeing it as a valuable tool to share disease awareness information. The company was, until recently, unsure as to whether it should even open a Twitter account, says spokesman Zachry Barber. It ran a two-week pilot Twitter effort back in January and, after accumulating over 200 followers in that short amount of time, realized Twitter could be a great way to stay in touch with people following the company’s progress, Barber says.

Richard Pops, CEO of Alkermes, has a Twitter account, even though his company doesn’t. “Because it is me, not Alkermes, I try to avoid bland corporate statements and links to press releases,” he says. He also doesn’t tweet about Alkermes’ products. “We have taken the position that tweeting about an Rx product, even with a link to more information, is not appropriate. Plus, I think people see right through self-serving comments that do not trigger more thinking and dialog,” he says.

To illustrate the challenge, here’s a recent tweet from Genentech, which has a Twitter page with over 3,000 followers:

“Genentech announces Ph III PRIMA study results: people with lymphoma stayed in remission longer with GNE medicine http://tinyurl.com/2cb9bfc”

The tweet takes us to the company’s press release, whose title is a little more nuanced: “Phase III Study Showed First-Line Maintenance Use of Rituxan® Improved the Likelihood of People with Follicular Lymphoma Living without Their Disease Worsening.”

I contacted the company to ask about its tweet, curious about how it decided on its slightly more user-friendly language for the Twitter version. The company declined to comment, but I wonder if it looked to the FDA for inspiration.

That’s because, ironically, even though it hasn’t issued rules on the do’s and don’ts of social media engagement for pharma and biotech companies, the agency itself is an avid Twitter user and keeps several Twitter accounts. Here’s a recent tweet from the FDA’s drug info page:

“FDA approved Pancreaze Delayed Release Capsules, a pancreatic enzyme product (PEP). Third PEP to receive approval. http://bit.ly/pancreaze”

Of the pharmaceutical companies, Pfizer seems to be taking the strongest stance, asking the FDA to provide clear regulations, and not just guidance, regarding the use of social media. Until the agency does so, Pfizer argues, a lot of companies will stay away from these kinds of activities for fear of litigation or regulatory action.

Keeping companies’ marketing tentacles from further creeping into cyberspace might not be such a bad thing, come to think of it, but the problem is that a lack of clarity regarding online communications affects much more than just advertising and drug promotion.

For example, companies are struggling to figure out what to do about adverse event reporting. Right now, patients who think they might be suffering from a drug side effect can report it directly to the FDA, or they can call manufacturer hotlines. Either way, the process is fairly standardized and certain criteria must be met in order for the complaints to be considered a true adverse event report.

But in the era of Twitter and Facebook, especially when users’ identities can be much harder to track, things could get a lot more complicated. Say a patient tweets that he has suffered a horrible side effect from a company’s drug. How far does the company need to go to track down the patient and proactively seek out a formal report? AstraZeneca says its policy is to report all adverse events, no matter the source. But without clear guidelines, one company’s definition of a case that deserves follow-up might be different from another, says Bob Perkins, AstraZeneca’s vice president of public policy, who wrote recently on the company’s blog about some of these issues. “That’s the kind of thing we’re going to need clear guidance for,” he says.

Sylvia Pagán Westphal is Xconomy's life sciences columnist. You can reach her at swestphal@xconomy.com or you can follow her on Twitter at http://twitter.com/sylviawestphal. Visit http://www.xconomy.com/author/swestphal/ for Sylvia's full bio and disclosures. Follow @

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