Healthy Skepticism Library item: 19297

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Electronic Source

Pogachar M
Questions Linger on Social Media Regulations for Pharma
iHealthBeat 2011 Mar 1
http://www.ihealthbeat.org/features/2011/questions-linger-on-social-media-regulations-for-pharma.aspx#ixzz1FProUyyp

Full text:

Consumers increasingly are tapping the Internet and social media sites for health-related information. A recent survey conducted by the Pew Internet Project and the California HealthCare Foundation, which publishes iHealthBeat, found that 80% of Internet users look up medical-related information online. According to the survey, online searches for specific diseases or medical problems are among the most popular health-related inquiries.
While online, consumers are likely to view promotions for health care products, but there currently are no federally imposed rules of the road governing pharmaceutical marketing activities.
Many observers expected that by the end of 2010 FDA would have released guidance governing how pharmaceutical companies can use digital and social media to promote FDA-regulated products. However, FDA says the earliest it will take action is the first quarter of 2011, according to the Division of Drug Marketing, Advertising and Communications at FDA.
Why Guidelines Are Needed
In August of last year, FDA sent a letter to Novartis warning that the drugmaker was improperly using a “Facebook Share” widget to promote the leukemia drug Tasigna. The widget allowed Facebook users to post comments about the drug to their profiles and to share that online content.
In the letter to Novartis, Karen Rulli — group leader of FDA’s DDMAC — wrote, “The shared content is misleading because it makes representations about the efficacy of Tasigna but fails to communicate any risk information associated with the use of this drug.”
Rulli went on to describe how use of the Facebook application led to:
Omission of risk information about the drug; and
Misleading statements suggesting a broader use of the drug other than what it is approved for.
Novartis subsequently took down the Facebook widget.
Meanwhile, in November 2010, four consumer advocacy groups filed a complaint with the Federal Trade Commission alleging that some websites are engaging in deceptive marketing tactics involving users’ personal health information. Among other charges, the groups alleged that certain websites collect data on users’ medical conditions, medications and treatment plans and that the data collection methods pose risks to the privacy and health of individuals.
Jeffrey Chester — founder and executive director of the Center for Digital Democracy — said that without strong safeguards, “drug companies will run rampant … to push drug sales at the expense of public health.”
Drugmakers and marketers argue that consumers are empowered by sites that allow users to conduct health-related research and to join support groups to share their experiences. However, consumers may be unaware of how their personal information or online habits are used and monitored, according to Chester.
“Consumers have no understanding, nor really should they, of the far-reaching data collection and interactive marketing tactics that embody social media and online advertising today,” he said, adding, “We’re not talking about buying a pair of pants. … We’re talking about potentially a serious medical condition that may be affecting you personally or your family. We’re talking about the cost of drugs that you yourself may buy. We’re talking about a special set of activities that require certain safeguards.”
What Guidelines Could Look Like
FDA hosted a two-day hearing in November 2009 to gather public comments on the promotion of agency-approved products through the Internet and other social media tools.
According to Crystal Rice, an FDA spokesperson, DDMAC is studying guidelines on several fronts, including:
How companies can respond to unsolicited consumer requests;
How companies can comply with regulations in the face of space constraints on sites like Facebook and Twitter;
How companies can fulfill post-marketing submission requirements;
What type of communications manufacturers or distributors are accountable for;
Using links on the Internet; and
How to correct misinformation.
DDMAC added that it is seeking “to issue one draft guidance that addresses at least one of these topics,” but officials could not comment further on whether there will be “any specific order in which the topics will be addressed.”
Rice said the industry has to find a harmony between offering information to consumers and health care professionals and making sure that that information is not misleading. In the “best interest of public health,” FDA is urging “the regulated industry to ensure their product promotion is accurate, balanced and non-misleading regardless of the medium,” Rice said.
Chester agreed that FDA’s regulations must be consumer-focused. However, he added that he believes the regulations should be developed in concert with the Federal Trade Commission, noting that FDA itself is not in a position to set comprehensive regulations governing the use of digital and social media for pharmaceutical marketing practices.
“FDA is still catching up on the impact of television advertising and has not really invested in the resources so it can address digital marketing and public health,” he said.
Looking Ahead
To be sure, the ever-evolving landscape of digital and social media will present challenges to pharmaceutical firms and to federal officials who monitor activity.
As the industry awaits FDA guidance, some firms are taking matters into their own hands.
For example, the pharmaceutical companies Pfizer and Roche recently have unveiled in-house social media playbooks to advise employees on how to handle social media.
“There’s going to be tremendous growth in the ability of social media to promote Pharma brands,” Chester said, adding, “You’re going to see tremendous advances in how online digital media push consumers into making product decisions.”
The opportunities to disseminate and share information across a global, online enterprise are almost incalculable, as is the amount of data at the fingertips of anyone with an Internet connection or smart phone. It remains to be seen how product marketing will co-exist alongside FDA scrutiny and just how detailed FDA guidelines will be.
The situation “is clearly a flashpoint,” Chester said.