Washington Editor

WASHINGTON - While the FDA now uses Twitter to communicate to the public, ambiguity about what the government deems acceptable for promoting medicines online has left drugmakers somewhat shutout from the social media world, they contended Thursday.

Medication manufacturers have reason to be skittish, given the FDA last spring slapped 14 firms with warnings about their search engine advertisements.

Michele Sharp, senior director of U.S. regulatory affairs for Indianapolis-based Eli Lilly and Co., said her company has avoided significant interactions with health professionals and patients in social media forums largely due to a lack of clarity of the FDA's expectations.

But regulators said they want to provide more clarity to the drug industry and are evaluating the FDA's advertising policies to meet the evolving Internet environment.

In what was being called the "Superbowl" of FDA public hearings, regulators heard from more than 30 speakers Thursday at the first of a two-day meeting about what types of medical product promotion should be permitted on Twitter, Google, Facebook, YouTube and other Internet and social media sites.

Thomas Abrams, director of the FDA's Division of Drug Marketing, Advertising and Communications, noted that more than 800 people had attempted to register for the highly anticipated event, with many people being turned away from the 350-seat conference center where Thursday's meeting was held.

The FDA convened the hearing to gain input about the types of online communications for which drugmakers should be held accountable, how risk information should be disclosed in limited-space sites, the use of links and the parameters for posting corrective information on third-party sites.

On Friday, regulators are expected to sit through about 50 more presentations, nearly half of which will be devoted to drugmakers' responsibilities and obligations for monitoring blogs, chat rooms and other online discussions about adverse events and reporting that information to the FDA.

About 83 percent of adult Internet users, or 61 percent of U.S. adults, search online for health information, according to the Pew Research Center, a nonpartisan think tank.

Pharmaceutical manufacturers are "well-positioned to provide accurate, scientific product information and related resources online," Lilly's Sharp told a panel of regulators Thursday.

But numerous unregulated sources are "significantly contributing" to the body of health care information on the web, with what often is inaccurate, incomplete or imbalanced information, she contended. "With support from the FDA, via appropriate mechanisms, the pharmaceutical industry can more effectively balance and otherwise address these concerns with regulated content and help patients achieve better outcomes," Sharp said.

While Lilly recently launched a blog on Medscape for physicians, which permits participants to post comments, the company, through its prescreening process, declines to post any mention of drug products, she noted.

"It is unclear what our fair-balance obligation will be if we allow such posts and how to meet that obligation with the limited constraints of a blog or other social media vehicle," Sharp explained.

The FDA's warning letters last spring about paid search engine ads, or sponsored links, "have only heightened that uncertainty," she insisted.

In addition, Sharp said, Lilly has been concerned that if it allows product discussions on its Medscape blog "they could easily stray into off-label topics, potentially resulting in accusations of off-label promotion."

A new social media dilemma drugmakers are facing, Sharp said, is a tool from Google called Sidewiki, which allows anyone to make comments on any website, with those comments viewable to anyone who has the tool installed and running in their Internet browser.

"Google Sidewiki essentially creates an independent website over which we have zero control, allowing people to comment on the website to which the Sidewiki is attached, including our product website," Sharp explained.

But, she lamented, comments on some of those sites have included "seemingly fabricated adverse events, inaccuracies and other items of concern."

While website owners can claim a "first comment position," Lilly has avoided doing so in part because it is unclear whether that would make the company responsible for all of the comments, including the off-label drug comments posted on that Sidewiki page, "even though we can't control them," Sharp said.

Jeff Francer, assistant general counsel at the Pharmaceutical Research and Manufacturers of America, suggested that drug regulators approve the use of the FDA's logo or a new universal agency-approved graphic safety symbol for websites to indicate that a linked page contains the manufacturer's regulated risk information.

Such a symbol could be used in places throughout the Internet where there is not enough room for complete disclosure of all of a drug's warnings, indications and contraindications, Francer said.

But Allan Coukell, director of the Pew Prescription Project, said it would be "inadvisable" to include an FDA logo on anything that might suggest an endorsement from the agency of a product or promotion.

He urged the FDA to be cautious in changing any of its advertising guidelines.

Diana Zuckerman, president of the patient advocacy group the National Research Center for Women & Families, said any new guidelines should require drugmakers to be responsible for the accuracy and balance of all product information that appears to be promotional, regardless of the "ostensible source of that information."

She noted that many third-party blogs and patient websites are in fact "bought and paid for," either directly or indirectly, "by the companies whose products are being praised."

But Peter Pitts, president of the Center for Medicine in the Public Interest, urged the FDA not to adopt the opinion that came out of the European Court of Justice, which concluded that information about medicines produced by independent third parties, without any commercial interest, may constitute advertising, even if the third party is acting on its own initiative and completely independent of a manufacturer.

"That is carte blanche for almost a complete gag order on anyone who wants to discuss anything to do with regulated health care products," Pitts charged.