Washington, D.C. (March 9, 2010) — Pharmaceutical Research and Manufacturers of America (PhRMA) Senior Vice President David E. Wheadon issued the following statement regarding patients’ access to reliable health information online:
“PhRMA member companies are committed to providing patients and healthcare professionals with truthful and scientifically accurate information about the life-saving and life-enhancing medicines they research, develop and manufacture. To that end, PhRMA is proposing that the Food and Drug Administration (FDA) issue new guidance detailing how biopharmaceutical research companies may use social media to help patients and to improve public health; the guidance eventually could be adopted as regulations.
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“PhRMA and its member companies remain committed to working constructively with the FDA to help develop these Internet-specific standards.
“As was clear from the FDA’s recent two-day public meeting on this topic, millions of patients and healthcare professionals turn to social networks, blogs and other social media tools to gather health information and to share their experiences with other Internet users. 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.
“At a time when more than half of adults first turn to the Internet to find health information, the extraordinary volume of dangerous and inaccurate information about medicines on the Web makes the FDA’s leadership on this topic all the more essential. What’s more, the Agency should avoid chilling manufacturers’ responsible communication about their medical products and should permit them to take full advantage of the same technologies that the FDA and the White House use – including blogs, video, search and such social networking sites as Twitter™ – to communicate important health information directly to patients and their doctors.
“As outlined in our detailed comments to the FDA, PhRMA seeks:
“Universal symbol. The FDA should adopt a prominent universal symbol to indicate a direct link to FDA-regulated risk information online. While certain technologies and increasingly popular platforms – such as handheld devices – emphasize brevity, more information can be provided by hyperlink or other technologies, like rollover. The use of the FDA’s own logo or other FDA-approved symbol would shine a brighter spotlight on official Web sites of FDA-approved medical products containing reliable and comprehensive information about medicines’ benefits and risks.
“Introductory warning information. The FDA should allow manufacturers to present brief introductions to health information in electronic formats, just as the FDA now does in its own tweets. Postings in space-constrained media, such as sponsored search results, would include a standard universal warning that would be approved by the FDA, such as: ‘All drugs have risks. Click here for more information from the manufacturer.’ The link would take consumers directly to comprehensive risk and benefit information.
“Responsible microblogging of newsworthy regulatory events. FDA has set a laudable example in its own use of Twitter to broadcast newsworthy events, such as new product approvals. Given space constraints and consistent with FDA’s own use of such media, the Agency should allow biopharmaceutical manufacturers to serve as responsible stewards of newsworthy information about their products and should permit manufacturers to microblog about significant scientific and regulatory events. Importantly, FDA regulations allow for the exchange of scientific information that is neither advertising nor promotion. Such exchange of scientific ideas can and should continue online.
“PhRMA hopes that all of the proposals contained in our 16-page submission to the FDA help to inform the Agency’s guidance on how to best communicate the benefits and risks of medicines in new, online media.
“Already, biopharmaceutical companies provide the only FDA-regulated promotional information about medicines online.”
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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