The proliferation of online health information and media vehicles such as blogs and social-networking sites create a new problem for the consumer—how to judge the reliability of such information. To address that problem, the US Food and Drug Administration is holding hearings this week, Nov. 12–13, in Washington DC, regarding the promotion of FDA-regulated medical products using the Internet and social-media tools. The hearings, which will include participation from pharmaceutical trade associations, drug companies, consumer groups, and media representatives, is the first step in a public dialogue that FDA is having as it evaluates how the statutory provisions, regulations, and policies concerning advertising and promotional labeling should be applied to product-related information on the Internet and newer media technologies.
The Pharmaceutical Research and Manufacturers of America (PhRMA) issued a statement this week supportive of such efforts and suggested the use of an FDA logo to identify online information that is FDA-regulated health communication. “PhRMA looks forward to working with the Food and Drug Administration and diverse stakeholders to identify ways in which our member companies may continue to communicate about their medicines online in truthful, scientifically accurate, and nonmisleading ways,” said PhRMA Senior Vice-President Ken Johnson in the statement. “Given the unprecedented growth of the Internet as a source of health information, the FDA should facilitate the appropriate use of online media by America’s pharmaceutical research and biotechnology companies to provide FDA-regulated information on medicines. “
Johnson points out that other federal entities such as the White House, the Centers for Disease Control and Prevention, and FDA use new media devices such as blogs and Twitter. “Going forward, the agency [FDA] could promote the responsible use of the Internet to benefit patients by shining a brighter spotlight on legitimate, FDA-regulated health communication,” he said. “One way the FDA could accomplish that aim would be to adopt a single, easily recognizable logo to help guide patients and healthcare providers to FDA-regulated information about medical products, including manufacturer websites. Leveraging the FDA’s logo—or a universal FDA-approved graphic symbol—in search results and throughout the Web would inform patients, at a glance, that they are visiting a legitimate site that contains comprehensive FDA-regulated benefit and risk information. Such a graphic symbol could be combined with a universal warning statement to provide an indication of risk when there is little space (e.g., a search result or tweet).”
In a preview of the testimony that it will be providing, PhRMA held a briefing with the media. The association said that its recommendations for FDA fall into three broad categories: patient safety, access protection, and accountability. “The FDA should sign a brighter spotlight on legitimate FDA-regulated health communication to help further mitigate the very real public-health threats posed by unregulated, illegal Internet drugs sales. Our proposal for an FDA-authorized universal symbol speaks to this,” said Jeffrey Francer, PhRMA’s assistant general counsel. “…Any FDA regulations must enhance, not detract from, a style of communication that has helped to improve patient health by taking into account the unique characteristic of the medium, for example, limited space and the unique design parameters of search,” he said. He added that “the proposed FDA regulatory framework should reflect a balanced approach to manufacturer accountability. Pharmaceutical companies control their own sites, their own agents, and their employees, but there is no sensible basis to hold manufacturers responsible for third-party statements, such as statements that the manufacturer did not cause or cannot control.”
PhRMA also pointed to the need for oversight considering increased consumer use of the Internet for health and drug information. Lori Reilly, vice-president for policy and research at PhRMA, cited a recent Pew Research Center survey that found that 83% of Internet users look online for health information, and 45% of Internet users research drug information—either prescription or over-the-counter drugs, up from 34% in 2002.
In addition to the public hearing, FDA is accepting written comments on the matter until February 28, 2010. Such efforts are a first good step in evaluating how to safeguard the use of Web-based health and drug information.