At a meeting convened by the Food and Drug Administration, pharmaceutical and medical device manufacturers, advertisers, medical Web site owners, search engine companies, and consumer advocates argued for greater regulation of health-specific content on the Internet, including social media sites.
The agency sought opinions on how it could guide health-related communications and promotions for YouTube, Twitter, blogging, and social networking sites. No speakers from medical society or health care provider organizations attended.
The Food and Drug Administration will accept comments until Feb. 28, 2010, said Thomas W. Abrams, director of the FDA Center for Drug Evaluation and Research's division of drug marketing, advertising, and communications.
All speakers agreed that consumers and health care providers increasingly rely on the Internet for information about drugs, devices, and specific conditions, and to forge communities to share everything from caregiving recommendations to tips on how to perform a knee replacement.
They also agreed that there is much inaccurate and misleading information, which aas a great potential for harm to patients and their families, health care providers, and industries seeking credibility. Even as they seek to be the go-to place for accurate, scientific information, drug and device makers said they are wary—of social media in particular—because of the lack of FDA guidance.
Consumer groups raised the specter of pharmaceutical or device companies putting out purely promotional information that glosses over FDA rules requiring a fair balance of a product's risks and benefits.
Michele Sharp, senior director of United States Regulatory Affairs at Eli Lilly, said the company “had avoided significant interactions with providers and patients online” because of the FDA's lack of clarity. “We're looking to the FDA to provide leadership,” Ms. Sharp said.
Jeffrey K. Francer, assistant general counsel for the Pharmaceutical Research and Manufacturers of America, said “the FDA should facilitate manufacturers' communication of important medical information about their products in a responsible way.”
PhRMA has proposed that posts on social media sites be accompanied by an official logo that would signify that the information was officially sanctioned by the FDA. Tweets, limited to 140 characters, could provide hyperlinks to full risk and benefit information, Mr. Francer said.
He and other industry representatives said they wanted FDA to review information and promotional materials before they were posted on the Web. This would be a departure from current policy where only a small fraction of print or broadcast materials are reviewed in advance.
Some groups are trying to establish rules before FDA does. The Interactive Advertising Bureau is developing standards to provide “safe harbors” for the drug and device industry,.said IAB representative David Wright. The Social Media Working Group is discussing what drug companies can do to self-police, said Mark Gaydos, chairman, and a regulatory affairs director at Sanofi-Aventis U.S.
Google proposed its own standards for “sponsored” searches. The search result would include a link to the official drug site and a link at the end, “more info,” which would take users directly to the risk information, said Amy Cowan, head of industry for Google's health division. Results would include a short warning statement.
Consumer advocate Diana Zuckerman, Ph.D., president of the Washington-based National Research Center for Women and Families, said the FDA must monitor the Internet and social media. The center, along with Consumers Union, will push for higher users fees to fund policing of the Web, she added.