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PhRMA proposal on social media

The Pharmaceutical Research and Manufacturers of America has proposed that the FDA approve a standardised graphic and warning that could be used on company-sponsored web content

In testimony released in advance of this week's US Food and Drug Administration public hearing on social media, Pharmaceutical Research and Manufacturers of America has proposed that the FDA approve a standardised graphic and warning that could be used on company-sponsored web content such as microblogs where there is not enough room for complete disclosure of all warnings, indications and contraindications.

“One possible solution might involve the FDA approving prominent use of the FDA's own logo or a new universal FDA-approved graphic symbol, along with a standard universal warning that would be approved by FDA (eg, “All drugs have risks. Click here for more information from the manufacturer”) in places throughout the website where there is not enough room for complete disclosure,” according to the testimony, which will be delivered at the November. 12-13 hearing by Jeffrey K, Francer, PhRMA's assistant general counsel.

PhRMA proposes that the graphic and link could take users directly to a drug's full FDA-approved prescribing information or medication guide. “The use of the FDA's own logo, or some other FDA approved symbol, would increase the prominence of the link and also help patients and healthcare professionals identify the official manufacturer sites containing FDA-regulated benefit and risk information,” the trade group points out.

PhRMA is making the proposal in response to debate about whether company-sponsored web content should have to carry the same risk information as traditional print advertisements do under the FDA's regulations. The FDA has not yet formulated a comprehensive policy on this and other key issues related to pharma companies' use of social media; the public hearing is considered to be the first step in that process.

PhRMA will also use the hearing to voice its concerns about the potential for pharma companies to be held accountable for third-party information about their drugs on the web. The testimony asserts that companies should only be held responsible for sites whose content is controlled and funded entirely by the manufacturer. “Attributing statements to a manufacturer that the manufacturer did not cause or control would… be untenable,” PhRMA maintains. “Such third-party statements simply do not fall within the definition of either advertising or labeling.”

The trade group's testimony points out the near impossibility of pharma companies being able to monitor everything on the web that pertains to their drugs, as well as the companies' general inability to control or change information posted by other parties.

The testimony asks the FDA to move quickly to create a social media policy that prevents misuse of the internet but allows pharma firms enough flexibility to make the most of the web as a communications tool. The document points out that government agencies including the FDA already make use of blogs and social networking technologies such as Twitter to communicate effectively with the public. “As demonstrated by the FDA's own use of Twitter, it is clear that information about medicines can be provided in a truthful, non-misleading manner,” the testimony states.

11th November 2009


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