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UPDATE 2-U.S. FDA tackles gray area of social media

Thu Nov 12, 2009 7:40pm EST

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* More than 800 people tried to register for FDA event

Stocks  |  Regulatory News  |  Healthcare  |  Technology

* Lilly, Yahoo call for 'clarity' on FDA guidelines

* FDA urged to communicate with Wikipedia, other sites (Recasts more comments from Google, Yahoo, Johnson & Johnson)

By Deepa Seetharaman

WASHINGTON, Nov 12 (Reuters)- Drug makers, Internet companies and nonprofits called for clarity on what is a gray area for U.S. health regulators: how drug promotion on Twitter, Wikipedia, blogs and other social media can be regulated.

The two-day Food and Drug Administration hearing aims to find out if the agency needs to specifically regulate how drugs and medical devices it oversees are promoted on the Internet.

"The lack of clarity today is creating confusion among the advertising community," said David Zinman, vice president at Yahoo Inc (YHOO.O).

The FDA already has strict rules governing what drug makers can say in magazine, newspaper and television advertisements, but the fast-evolving online world is a Wild West when it comes to what is -- and is not -- possible to regulate.

In April, the FDA sent warning letters to 14 companies including Eli Lilly and Co (LLY.N) and Merck & Co Inc (MRK.N) about their drug marketing online, saying that ads for certain products were misleading and did not contain any risk information.

Since those letters, pharmaceutical companies have changed the way they design their ads and no longer include the brand name, Google Inc (GOOG.O) and Yahoo representatives said.

Google officials said the click-through rate on these ads "dramatically decreased" after April. They offered another ad design that offers consumers links to risk information.

"Users see all these links and they don't know exactly where they're going until they get there," Zinman said.

TACKLING TRICKY QUESTIONS

More than 800 people tried to register for the event, which was held in a conference room that seats 350. Others followed the speeches online and posted messages about it on Twitter.

The FDA organized about 30 different presentations on Thursday on topics ranging from drug makers' role in monitoring Internet content to data on how consumers get their health news.

Participants were asked to consider a number of questions, including how much responsibility drug makers bear for online content about their products and how to determine when online chats about a medicine are influenced by the manufacturer.

"We don't think companies should be responsible for policing the entire Internet for information about their products," said Johnson & Johnson (JNJ.N) executive Elizabeth Forminard.

One advocate noted there is a general lack of consistency about the quality of information on frequently-used third-party websites, such as Wikipedia.

"Because the risk of providing inaccurate information on medical products is so high, the FDA needs to establish ongoing relationships with ... websites consumers are relying on," Diana Zuckerman, president of the National Research Center for Women and Families, said in her remarks.

Thomas Abrams, director of FDA's drug marketing arm, is one of a dozen FDA officials who will analyze the public comments to decide what action, if any, the agency needs to take.

The agency is accepting comments through February 2010.

The FDA is webcasting the hearing at: here (Reporting by Deepa Seetharaman; editing by Tim Dobbyn and Andre Grenon)



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