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AstraZeneca Suggests Message Guidelines To FDA

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In response to the U.S. Food and Drug Administration's request for comments on new rules for online marketing and communications, AstraZeneca has outlined some ways that pharma company interactions with customers and potential customers might be governed.

The Wilmington, Del.-based drug maker suggests that certain online communications -- such as Facebook and Twitter posts -- should be judged not one by one, but as a group of individual comments. That would enable pharma companies to participate in those sorts of social-media sites without having to balance benefits and risks at every 140-character turn.

AstraZeneca also calls attention to the differences between content on Web sites a drug maker owns and controls, compared to sites where it provides content for sponsors to use as they see fit. Also figuring prominently in the discussion are social media sites, which would include real-time company communications. Different rules should apply in different contexts, the drug maker suggests.

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The proposal is in response to the FDA's September 2009 Call for Comments on their public notice: Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools.

"AstraZeneca understands the value of social media to engage key stakeholders in today's technology-driven world," says Bob Perkins, vice president, public policy and promotional affairs, in a statement. "While we have developed a corporate presence in the digital space, we believe it is increasingly important to participate in online channels to provide accurate and regulated information about our branded products in conversations with patients, caregivers, and health care providers."

AstraZeneca believes that five principles should be followed by any pharma company engaging in social media. First, companies should only present content that is accurate, balanced and not misleading. Second, companies must be respectful and encourage product sponsor participation that respects the interests of patients, caregivers and health care providers -- especially related to matters of privacy and the primacy of the patient/physician relationship.

Third, companies have a responsibility to protect and advance patient health by facilitating patient access to quality information for use with their physician to improve their health and protect patients through encouraging accurate and timely reporting on medicine safety. Fourth, companies should be transparent, meaning that any product sponsor participation should be accomplished in a manner that, at all times, is entirely transparent to other participants as to the role of product sponsors as participants in online discussion.

Finally, companies need to respect the views of others. They should acknowledge that patients, caregivers, clinicians and others who participate in social media have their own opinions and that when they differ from those of the product sponsor, it is not the role of a product sponsor to censor or limit these views, but to add the product sponsor's own views to the discussion.

In its comments to the FDA, AstraZeneca proposed a regulatory framework that is consistent with these principles and defines, distinguishes, and distinctly regulates three types of communications on the Internet and in social media that are company-controlled, hosted online communications; company-controlled communications and real-time, social media participation communications.

"Without guidance, our activities are limited in a manner that we believe is not in the best interests of informed health care decision making," the company told the FDA. "In our absence, consumers will turn to information sources that are not regulated and not always well informed."

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