Sunday, December 19, 2010

Big Pharma's small voice

Out of fear of federal regulation, drug companies shun social media

Written by Jonathan Starkey (The News Journal)

Source: Delaware Online

It's all too common these days to wake up in the morning, fire off a tweet about some piece of news, then log onto Facebook to drone on about one thing or another.

For most, it's all pretty simple, and safe.

Not for Big Pharma.

Executives at pharmaceutical companies are all tied in knots about what they can and can't say through social media sites like Twitter, Facebook and other popular Web forums where patients and doctors congregate.

They worry that one wrong move will land them in the penalty box with the U.S. Food and Drug Administration, their federal regulator.

A recent survey from audit and consulting firm Deloitte found that 35 percent of companies surveyed had no interest in social media, a striking number given that the general public seems enamored with such 21st century pleasures as Tweeting on Twitter and Friending on Facebook. Many firms see the new media as a gold mine for customer engagement.

But more than half of firms surveyed by Deloitte said confusion about what regulators believe is appropriate communication over social networks gives them heartburn about participating.

Promoting a branded drug over Twitter, for example, is virtually unheard of. Even observing conversations at more private forums like, a professional networking site for doctors, has its dangers.

"Our concern is particularly around what the FDA is going to think about social media and the fact that you're really at times limited in what you can communicate," said Fritz Bittenbender, a spokesman for Frazer, Pa.-based Cephalon, which makes the sleep-disorder drug Provigil.

Cephalon recently issued a set of new media guidelines to its employees that cautioned them against promoting products through their personal accounts.

"The FDA could see that as an official corporate message," Bittenbender warned.

Pharmaceutical companies have become masters at pitching their products in old media outlets. Think of those fancy Viagra ads on TV. Or full-page spreads in mass-market magazines hawking the latest and greatest cholesterol pill.

In 1997, the FDA issued rules allowing those direct-to-consumer ads, so long as the drugmaker also discussed the corresponding risks and side effects of the medicines.

It's the lack of similar rules for social media -- where room for messaging is often more limited -- that has made big pharmaceutical players sheepish about entering the space.

Many in the industry believe the Food and Drug Administration is dragging its feet on issuing guidelines for social media use, according to consultants who coach pharma types on using new media tools.

Regulators held a two-day meeting on the topic last November, but have remained mostly silent about guidelines since.

FDA spokeswoman Shelly Burgess said the agency still plans to issue a set of social media guidelines before year's end.

"I think there's a lot of pessimism because it's taken them a year to do something," said Phil Charron, a senior director at Conshohocken, Pa.-based Think Brownstone, which consults with pharma companies.

Meanwhile, the regulator's delay in issuing guidance hasn't kept it from reacting strongly to pharmaceutical companies it believes are using social media networks inappropriately.

In a letter sent in August, and posted to its website, the FDA dinged Swiss drug giant Novartis for its use of a Facebook-sharing widget on a website for its leukemia drug Tasigna.

The widget was a button that allowed the site's visitors to share the drug's information with their friends on Facebook.

Problem was, the FDA, said, the information that carried over to Facebook -- descriptive metadata stored in the page's code -- didn't contain any mention of the drug's risks.

"The shared content is misleading because it makes representations about the efficacy of Tasigna but fails to communicate any risk information associated with the use of this drug," the FDA wrote in its letter, ordering the company to "immediately cease the dissemination of violative promotional materials."

Consultants say this presents one of the most perplexing issues for pharmaceutical companies looking to engage on social networks: How do you communicate risk in limited space, like the 140 characters allowed by Twitter for a single message?

Charron said most hope the FDA will allow companies to place the risk warnings "one click away." But the default position for now, without that guidance? Companies avoid promoting branded products through new media.

Representatives of pharma companies also are often advised to steer clear of doctor and patient forums like, where their participation may be helpful, but raises the risk of regulatory run-ins, consultants say.

"At what point does something that's said around the performance of a product suddenly become a reportable event," said Terry Hisey, head of the U.S. life sciences practice at Deloitte. Hisey said companies remain uncertain about the answer to that question.

Charron, from Think Brownstone, says all of this means less information on the Web. And that's a big deal, considering that 61 percent of American adults look online for information about health care topics, according to a 2009 study from the Pew Research Center.

British drugmaker AstraZeneca, which has its U.S. headquarters and 4,000 employees in Delaware, has a strong presence on networking sites like Twitter, but keeps its accounts mostly focused on industry trends, or news that's non-controversial by any measure.

AstraZeneca's U.S. tweeters -- @AstraZenecaUS -- recently told their 4,134 followers that the company had received a "Community Partner of the Year," award, for example. It ignored news that the company's most important new drug, the blood thinner Brilinta, had failed to win regulatory approval.

In a memo to the FDA in February-- when the regulator was publicly studying the social media issue -- AstraZeneca said its participation on social networking sites was "intentionally quite limited."

"Without guidance, our activities are limited in a manner that we believe is not in the best interests of informed health care decision making," the drugmaker said. "In our absence, consumers will turn to information sources that are not regulated and not always well-informed."

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