* More than 800 people tried to register for FDA event
* Lilly: hesitant to use social media without FDA clarity
* FDA urged to communicate with Wikipedia, other sites
(Recasts with meeting under way; adds Eli Lilly, other
By Deepa Seetharaman
WASHINGTON, Nov 12 (Reuters)- Drug makers, Internet
companies and nonprofits packed a hearing into what is a gray
area for U.S. health regulators: how far Twitter, Wikipedia,
blogs and other social media can go in promoting drugs.
The two-day public hearing, convened Thursday by the Food
and Drug Administration, aims to find out if the agency needs
to specifically regulate how drugs and medical devices under
its oversight are promoted on the Internet.
"Consumers turn to the Web more often than the traditional
channels they historically relied on" such as family, friends
and doctors, Wayne Gattinella, chief executive of WebMD, a site
for health information, said during a presentation.
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.
Some frequently used websites have inaccurate or incomplete
information, and there is a lack of consistency about the
quality of information on websites like Wikipedia and
Drugs.com, Diana Zuckerman, president of the National Research
Center for Women and Families, said in her remarks.
"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," she
Other speakers slated for the event included
representatives of drug companies such as Eli Lilly & Co
(LLY.N) and Pfizer Inc (PFE.N), as well as Internet
heavyweights like Google Inc (GOOG.O) and Yahoo Inc (YHOO.O).
More than 800 people tried to register for the FDA event,
which was held in a meeting room that seats 350, said Thomas
Abrams, director of FDA's direct marketing arm. Abrams was one
of a dozen FDA officials who will analyze the public comments
to decide what action, if any, the agency needs to take.
An Eli Lilly executive for regulatory affairs told the FDA
panel that lack of clarity about the agency's guidelines have
prevented the company from participating heavily in social
media and discussing its products online.
John Mack, editor of online newsletter Pharma Marketing
News, and a blogger, said the FDA should require drug makers
apply certain "tags" or ID codes to Twitter posts to monitor
conversations about a product.
The Pharmaceutical Research and Manufacturers of America
industry group this week urged the FDA to adopt a standard
safety logo for Web content that would link to FDA-approved
information about a drug or device. [ID:nN09273270]
The logo suggestions attracted much interest from FDA
officials, who peppered Jeffrey Francer, PhRMA's assistant
general counsel, with questions. Francer said the logo's use
should be governed by the FDA.
The FDA announced the meeting, called the "Promotion of
Food and Drug Administration-Regulated Medical Products Using
the Internet and Social Media," in September.
Among questions the FDA asked presenters to address was:
what criteria should be used to determine when third-party
conversations are subject to "substantive influence" by
companies that market the products being discussed.
The FDA also asked speakers to discuss what online messages
drug makers are responsible for, how companies can achieve
balance in ads within the confines of a 140-character Twitter
message and when linking is appropriate or misleading.
The hearing comes after the FDA sent warning letters about
drug marketing online to 14 companies in April, including Eli
Lilly and Merck & Co Inc (MRK.N). The agency told both
companies that its ads online for certain products were
misleading because they did not contain any risk information.
The FDA is webcasting the hearing at:
(Reporting by Deepa Seetharaman; Editing by Tim Dobbyn)