Washington, D.C. (November 9, 2009) — Pharmaceutical Research and Manufacturers of America (PhRMA) Senior Vice President Ken Johnson issued the following statement regarding the FDA’s Nov. 12-13 hearing on patients’ access to reliable health information online:
“PhRMA member companies are committed to providing patients and healthcare professionals with balanced, accurate and useful information about the life-saving and life-enhancing medicines they research, develop and manufacture. To that end, PhRMA looks forward to working with the Food and Drug Administration (FDA) and diverse stakeholders to identify ways in which our member companies may continue to communicate about their medicines online in truthful, scientifically accurate and non-misleading ways.
“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.
“Federal entities, such as the White House, the Centers for Disease Control and Prevention, and the FDA itself already take advantage of new media technologies, such as blogs and Twitter™, to communicate important health information directly to patients and their doctors.
“Going forward, the Agency could promote the responsible use of the Internet to benefit patients by shining a brighter spotlight on legitimate, FDA-regulated health communication. 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 Web sites.
“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).
“Already, biopharmaceutical companies provide the only FDA-regulated promotional information about medicines online.
“The Agency’s leadership in regulating responsible use of social media would come at a time when the Internet has become an invaluable resource for patients and healthcare providers seeking health information, as evidenced by a recent Pew Research Center survey. Sixty-one percent of American adults now look online for health information, and 42 percent of adults say they or someone they know has been helped by health information found on the Internet, according to Pew.
- “The FDA could help patients and could better serve the public health by following this week’s public dialogue with guidance that outlines clear standards to help patients access truthful, reliable information on the Internet. Chief among PhRMA’s suggestions:“The FDA should adopt a prominent universal safety symbol – the FDA logo or other FDA-approved symbol – to indicate that a linked page contains the manufacturer’s FDA-regulated risk information. Use of this symbol throughout the Web would help healthcare professionals and patients identify the official Web sites of FDA-approved medical products containing reliable and comprehensive information about benefits and risks.
- “Because millions of Internet users are already accustomed to viewing pop-ups, mouse roll-over text, hyperlinks and other new media communication tools, the FDA should follow the lead of the Federal Trade Commission (FTC) in recognizing the space limitations of certain formats and the flexibility of the Internet in communicating warnings.
- “Just as FDA and the White House have embraced certain Internet technologies that emphasize brevity, such as blog entries and Twitter™, the Agency should facilitate the use of such technologies by biopharmaceutical manufacturers. For example, FDA should facilitate communication of abbreviated benefit and risk information, provided there is easy access to longer, comprehensive warnings through a prominently labeled hyperlink. The Agency could, for instance, facilitate the ability of manufacturers to combine brief ‘introductions’ to a health topic with prominent and clearly marked links that would provide access to the prescription medicine’s full indication and comprehensive risk information. Similarly, such information could be provided using roll-over or pop-up technology.
- “PhRMA applauds the vigilance of the FDA and FTC in uncovering and disrupting Internet-based sales of fraudulent H1N1 flu treatments as the nation faces a serious H1N1 outbreak and prepares for the annual flu season. Due to the very real public health threat and lack of accountability posed by illegal Internet drug sales, the FDA should redouble such enforcement efforts.
“PhRMA hopes that our proposals help to advance the conversation about how to best communicate the benefits and risks of medical products in new, online media.
The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country’s leading pharmaceutical research and biotechnology companies, which are devoted to inventing medicines that allow patients to live longer, healthier, and more productive lives. PhRMA companies are leading the way in the search for new cures. PhRMA members alone invested an estimated $50.3 billion in 2008 in discovering and developing new medicines. Industry-wide research and investment reached a record $65.2 billion in 2008.
PhRMA Internet Address: www.phrma.org
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For information on the Partnership for Prescription Assistance, visit: www.pparx.org
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