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FDA Hearing on Social Media

Posted by | 4:18pm on Wednesday, November 18, 2009

Overall, social media guidelines will require industry to provide innovative solutions to the FDA and for the FDA to create guidelines that can evolve with the medium, rather than place increasing constrictions on it. 

Angela Romano, Content Intern at Siren Interactive, contributes this post:

It finally happened — the FDA hearing on social media that people had been demanding for more than a year was held on November 12 and 13th. . With more than 800 people trying to get into this event and 76 presentations, it marked a historic moment in FDA history, considering the last hearing on internet related material happened in 1996. The question of the day: how far can Twitter, Wikipedia, blogs and other social media go in promoting drugs?

The two day hearing was designed to poll expert opinion from a wide range of experts on five key areas:

  • For what online communications are manufacturers, packers or distributors accountable?
  • How can manufacturers, packers or distributors fulfill regulatory requirements in their Internet and social media promotion, particularly when using tools that are associated with space limitations and tools that allow for real-time communications?
  • What parameters should apply to the posting of corrective information on Web sites controlled by third parties?
  • When is the use of links appropriate?
  • How should adverse event reporting be addressed online?

What Wayne Gattinella, chief executive of WebMD, said during a presentation summed up what every pharmaceutical company wanted to get across to the FDA:

“Consumers turn to the Web more often than the traditional channels they historically relied on such as family, friends and doctors. The FDA already has strict rules governing what drug makers can say in magazine, newspaper and television advertisements, but the fast-evolving online world is a Wild West when it comes to what is — and is not — possible to regulate.”

Most frequently used websites have inaccurate or incomplete information, and there is a lack of consistency about the quality of information on websites like Wikipedia and Drugs.com, Diana Zuckerman, president of the National Research Center for Women and Families, said in her presentation:

“Because the risk of providing inaccurate information on medical products is so high, the FDA needs to establish ongoing relationships with… websites consumers are relying on.”

The Internet has become a widely used medium for companies, including manufacturers and distributors of medical products regulated by FDA, to get out information about their products. The Internet’s ability to facilitate communication, information sharing, information exchange between systems, and collaboration has also evolved and it has raised questions and concerns over how to apply existing regulations to promotion in these newer media. FDA is evaluating how the provisions, regulations, and policies concerning advertising and promotional labeling should be applied to product-related information on the Internet and newer technologies. Clearly, the FDA regulations are unclear and need be revised for the ever changing social media world and advertising that goes along with it.

It seems some clear guidance about how the pharmaceutical industry should interact using the internet and social media is needed. The problem many pharmaceutical companies and researchers tried to get across to the FDA was that with the lack of clarity about the agency’s guidelines have prevented the company from participating heavily in social media and discussing its products online.

One of the best-received suggestions actually occurred on a social medium itself: Twitter. The advice given to the panel was from Zen Chu of Accelerated Medical Ventures, who said DDMAC needs to hire more people who are familiar with social media. Being a college student, social media is what young adults know best. Personally, I think our generation has a good chance of succeeding in the business world not only because of the access to a great education, but because of our familiarity with social media networks. Who knew hours spent on Facebook and Twitter a day would pay off in the end?

Among questions the FDA asked presenters to address was: what criteria should be used to determine when third-party conversations are subject to “substantive influence” by companies that market the products being discussed. In other words, are you responsible if another website posts untrue content about your company? This gets into the whole issue of libel, a big topic discussed in my media law and ethics class. If someone posts untrue information about yourself or your company on a website, what regulation is out there to protect yourself from this?

Overall, social media guidelines will require industry to provide innovative solutions to the FDA and for the FDA to create guidelines that can evolve with the medium, rather than place increasing constrictions on it.

This phase of the public hearing will continue until February 28, 2010, which is the last day to submit public testimony. The current thinking is that guidelines could emerge as early as summer 2010, although no formal commitment to a timeline has been given.

So, the big question remains. Will anything change?

About Frieda Hernandez

Frieda leads Siren’s business development, marketing and alliance activities. She has a reputation for developing innovative marketing strategies and building mutually beneficial client partnerships with biopharmaceutical executives. She advocates for authenticity and transparency in creating trust relationships online and is an avid participant in industry conferences and social networks to stay abreast of all the current issues.

View other posts from Frieda

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  • http://www.parapro.com Dana Webster

    Thank you for summarizing and posting it for all to view. I tried to listed to as much as possible via the live feeds, but obligations took me away from much of it on the second day.

    Much appreciated – to all who’ve kept the conversation going!

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