Dr. Katz said that using social media for real time adverse event reporting, patients supporting each other and helping with trial adherence were all positives 

I was fortunate to be invited to speak at the American Society for Experimental NeuroTherapeutics (ASENT) annual meeting on February 28, 2013 in Bethedsa, MD. What’s unique about this nonprofit organization is that it consists of representatives from the key stakeholder areas: healthcare, academia, biopharma, patient advocacy and government. At their event I met physicians, nurses, patients, advocacy leaders, brand managers and FDA officials.

I presented as part of an afternoon discussion on the “Use of the Internet and Social Media to Conduct Clinical Trials” with Russell Katz, MD, U.S. Food and Drug Administration (FDA); Joseph Kim, Shire Pharmaceuticals; Craig Lipset, Pfizer; Joanna Napp, HealthTronics; Lori Sames, Hannah’s Hope Fund; and Nancy Santilli, HealthTronics.

Dr. Katz, director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research, started off by admitting that not only was he not an expert in social media, but he doesn’t even have a smart phone! He’d asked around to see if anyone at the FDA was investigating the use of social media specifically for clinical trials and did not find anyone. Dr. Katz noted that the overarching idea is that the existing advertising rules apply, but it’s not yet clear how. He said, “The agency is working on it.” He mentioned that the FDA is working on an app to accept MedWatch reports via phone.
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This makes it clear that for health and safety products even the FTC won’t allow a hyperlink 

The pharmaceutical industry has yet to receive specific guidance from the U.S. Food and Drug Administration (FDA) on social media. People are wondering if the Federal Trade Commission (FTC) rule on social media, “.com Disclosures: How to Make Effective Disclosures in Digital Advertising,” on March 12, 2013 will have any impact on the FDA.

I suspect it will not, but it is still worthwhile to review the FTC guidance.

The FTC on social media
“When practical, advertisers should incorporate relevant limitations and qualifying information into the underlying claim, rather than having a separate disclosure qualifying the claim.” The FTC also appears to revive the mythical “one-click rule” that allows important information to be a hyperlink click away. “However, when it is not possible to make a disclosure in a space-constrained ad, it may, under some circumstances, be acceptable to make the disclosure clearly and conspicuously on the page to which the ad links.”

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Facebook is rolling out the timeline format to brand pages on February 29, 2012 

Siren is proud to support the Digital Health Coalition, a nonprofit created to serve as the collective public voice and national public forum for the discussion of the current and future issues relevant to digital and electronic marketing of healthcare products and services. Led by Mark Bard and Joe Farris, the Digital Health Coalition held an event on February 6 in New York City as part the ePharma Summit. Bard released and reviewed “Social Media and User-generated Health and Medical Content: Guiding Principles and Best Practices for Companies and Users.” I strongly recommend reading these common sense principles.

All the presenters were excellent, but I’m going to recap the regulatory focused presentations and the changes announced by a Facebook representative.

Mark Gaydos, Vice President, U.S. Regulatory Affairs Marketed Products at Sanofi, started off the sessions by sharing how Sanofi has been able to embrace social media. It’s especially admirable that Sanofi, which took a beating early on via social media, is using the space to have two-way conversations.

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It’s critical that those involved in marketing products for the drug and device industries be trained in regulatory compliance 

Compliance is a hot topic among biopharmaceutical industry and agency professionals, especially around social media. I had the chance with talk to two leaders in the field: Wayne Pines and Ilyssa Levins from the Center for Communication Compliance (CCC), an all-in-one source for training, mastery testing and consulting in regulatory compliance.

Wayne is a nationally recognized expert on regulatory aspects of healthcare advertising and promotion. He served at the FDA for 10 years as chief of consumer education and information, chief of press relations, and associate commissioner for public affairs. He was the FDA’s chief spokesman to the media for seven years and was the founding editor of its consumer magazine. Ilyssa has 30 years of healthcare communications experience, having spearheaded significant growth for Grey Global Group, one of the world’s foremost communications firms. Recognizing the need for a standardized regulatory compliance curriculum for promotional agencies, Ilyssa founded CCC, and Wayne is chair of the company’s advisory board.

I know Wayne and Ilyssa through Siren’s CCC training efforts. Siren is the nation’s first and only marketing agency to certify its entire staff in regulatory compliance for Internet Promotion/Social Media by CCC. Siren is also certified in Patient Relationship Marketing. The agency decided to dedicate the time and resources to obtaining this certification because healthcare regulations are an essential part of the work that we do. After taking the tests I wanted to learn more.

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there are lots of tactics that are possible right now – and examples of companies that are using them 

For the past few months, one of the most popular questions among pharmaceutical marketers has been: Will the FDA release social media guidelines or not?  Well, the current answer is no.

The FDA’s latest self-imposed deadline (first quarter of 2011) has passed without draft guidance. Industry veterans who attended the first hearing on the internet back in 1996 are unsurprised. The lack of formal guidance on the internet hasn’t stopped pharma/biotech companies from taking full advantage of the power of the web. The good news: even without FDA guidance on social media there are lots of tactics that are possible right now – and examples of companies that are using them.

It’s the Message, Not the Medium
Pharmaceutical marketers should continue to apply existing FDA guidelines to the internet and social media. Be sure to focus on applying fair balance. The majority of letters received regarding social media, such as YouTube or Facebook, have focused on issues with the message not the medium.

The Pharma Social Media Basics
Here are some low-risk social media tactics that every pharmaceutical company should be considering.
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I have dedicated my career to using this medium – ethically and responsibly – to educate and inform patients 

On November 23, 2010 the Center for Digital Democracy, U.S. PIRG, Consumer Watchdog, and the World Privacy Forum filed a complaint with the Federal Trade Commission over “unfair and deceptive advertising practices that consumers face as they seek health information and services online.” The groups’ 144-page FTC filing was also sent to Dr. Margaret Hamburg of the FDA and members of Congress. The press release summarizes the report.

The detailed report pulls information from industry publications, blogs, press releases and event agendas. Multiple pharmaceutical companies, advertising agencies, service providers and organizations are referenced. The list of interactive techniques that “pose threats” includes a variety of accepted pharmaceutical marketing practices such as e-detailing and unbranded disease awareness sites.
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spaghettisculpture

Metadata, which is invisible to anyone viewing a website in a browser, is part of the underlying page code. Search engines use this metadata: they pull the page title tag and description and display them on their results page. Anyone can view the site’s metadata by right clicking on a page. If you choose “view page source” from the menu that appears, you will see the code for the page, including the meta title and description.

Here’s an example of the metadata that has been written into the code for the homepage of Baxter’s ThereForYou.com:

Here is how it looks when Google pulls the metadata to display the title and the description in their organic search results:

Why Should Pharma Care?
The U.S. Food and Drug Administration (FDA) sent a letter to Novartis dated July 29, 2010, regarding a Facebook Share widget on their brand website, Tasigna.com. This widget pulled the content from the metadata. The FDA letter noted that this content did not contain fair balance.
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FDA Hearing on Social Media

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

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?

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The FDA and Web 2.0

Posted by Wendy White | 10:35 am on Thursday March 19, 2009 | 1 Comment

As marketers, we need to go where the conversation is happening, listen to our audience and push for a day when we can fully and responsibly participate. 

Mark Senak from Eye on FDA posted a conversation with FDA/DDMAC about pharma, social media and Web 2.0.

From his post:

“Despite the crushing amount of incentives to go digital, the pharmaceutical utilization of social media and Web 2.0 has been hobbled by regulatory concerns that participation might necessarily trigger FDA action in the form of a warning letter.  There have been a few pioneers in the space, but the majority of pharmaceutical firms are not engaged and sit paralyzed as control over their brands ebbs away into the ether.

To date, FDA and the Division for Drug Marketing, Advertising and Communications (DDMAC) has been relatively quiet on the subject.  While the agency has a number of guidances on a wide variety of topics, there is nothing on this topic.  In such a vacuum, many have made assumptions about the use of social media and for many, any time the subject comes up – it is a non-starter.” Read More