If pharmaceutical companies can't adequately explain the risks of drugs in 140 characters, they shouldn't be allowed to use Twitter to advertise. That's according to the consumer advocacy group Center for Digital Democracy, which on Monday asked the Food and Drug Administration to preserve current policies on drug marketing even if they hinder the use of social media.
"Current FDA guidance on the presentation of risk information should not be compromised to the detriment of public health in favor of accommodating recent developments in online product promotion," the CDD writes. The group adds that if services like Twitter, which impose limits on posts, leave companies "unable to satisfy basic consumer-protective measures such as the fair balance requirement," those services are inappropriate for drug marketing.
The CDD also says that drug companies should not advertise in a host of digital platforms -- including email and social networking boards operated by third parties. "The only legitimate use of such tools to communicate directly with consumers is via a company's own website, and only with adherence to full 'fair and balanced' information rules," the group writes.
While the FDA probably isn't likely to ban direct-to-consumer ads, the agency could well decide that it's inappropriate to pair a drug name with a particular condition when space is too limited to describe the potential side effects, says Rebecca Tushnet, a law professor at Georgetown and expert in false advertising law.
But, she adds, even if space is short, companies might still be able to use so-called "reminder ads," which typically give the name of products but not the ailments they treat. "In the non-Twitter context, people have solved this problem with the reminder ads," she says. "In theory, it seems like that approach could still work."
The FDA recently held hearings addressing drug companies' use of social media and other online platforms to advertise. Last year, the agency told 14 large pharmaceutical companies that their search ads were misleading because the ad copy touted the benefits of drugs without also informing consumers about risks and contraindications. Drug companies immediately revamped their search strategies, both by curtailing the use of search ads and by revising the content of the ads. Now, when drug companies buy keywords to describe medical conditions, many no longer include the brand name in the ad copy or URL.
by Wendy Davis
Showing posts with label fda. Show all posts
Showing posts with label fda. Show all posts
Tuesday, May 11, 2010
Wednesday, March 3, 2010
AstraZeneca Suggests Message Guidelines To FDA
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.
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."
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.
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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