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SURVEY: Should FDA Convene a Public Hearing on Use of Social Media by Pharma?

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Overcoming Barriers to Pharma's Engagement in Social Networks
An ePharma Pioneer Club Roundtable Discussion

Guests: A select group ePharma Pioneer Club Members and other guests -- including PhRMA -- participate in a roundtable discussion on what it's going to take to enable pharmaceutical marketers to engage in social networks without fear of adverse event reporting and other regulatory, corporate, and cultural roadblocks.

The major topic of discussion revolved around initiating a public process to inform the FDA and gudie it to develop guidelines for the use of social media by pharmaceutical companies for promotional purposes. Also discussed were issues beyond regulations that keep pharma companies from engaging in social media.

• Date recorded: Wednesday, April 8, 2009, 1:30 PM Eastern US time.
• Duration: 45 minutes

Background
This is a roundtable discussion amongst peers on the issue of overcoming barriers to pharma's use of the Internet and engagement in social networks for marketing and communications purposes.

What are the goals of this roundtable discussion?

As all of you probably know, the FDA just sent off 14 letters to different pharmaceutical companies about pay-per-click search engine ads that violated FDA regulations regarding fair balance. Although some of us felt in the past that these ads were perfectly kosher because of a so-called "one click rule," it turns out that this is not the case.

Mark Senak expressed our concerns well when he said in an Advertising Age article:

"The FDA is of the mind that they don't need to issue guidance specific to digital media because their current regulations cover that," said Mark Senak, senior VP at Fleishman Hillard and author of blog Eye on FDA. "Technically that's true. However, the internet presents a lot of situations that are somewhat nuanced and would lead to question in the mind of any reasonable person. Those questions deserve some answer. Formulating policy by issuing mass warning letters is not a valid way to set that policy or express it." (See http://tinyurl.com/cvh7gm).

I think most of us agree that there are several other ways in which pharmaceutical companies can get into trouble with the FDA when they use social media. Right now, there is NO guidance from the FDA on how they may look at social media marketing in the future. As recent FDA actions have shown, companies can be in for some bad publicity and risk losing sales if they are caught unawares. It is perfectly reasonable, therefore, for the drug industry to insist that the FDA come up with some guidelines for use of the Internet and social media.

Before the FDA goes off and creates guidelines, however, it is important that it understand the position of all stakeholders on this issue. 84% of respondents to my survey agree that before issuing any draft guidance, FDA should convene a public hearing in which ALL stakeholders -- including pharma, agencies, patient advocates, healthcare professionals, web site owners, etc. -- can put on record their suggestions and concerns.

Some of us have already approached the FDA on this and have been rebuffed. One goal of this conversation, therefore, could be to approach the FDA as a stronger coalition of concerned stakeholders and demand at least a private meeting.

Although it would be helpful for the FDA to release guidance for the industry on the use of social media, there is also a need to develop "best practices" that go beyond what the law requires. Some pharma companies are currently discussing this and that is perhaps what we can also do starting with this roundtable discussion.

Speakers

• John Mack, Publisher of Pharma Marketing News and founder of the ePharma Pioneers Club
• Jonathan Richman, Director of Business Development, Bridge Worldwide
• Fabio Gratton, Co-founder, Chief Innovation Officer, Ignite Health
• Rich Meyer, eMarketing consultant, author of The World of DTC Marketing Blog
• Rob Nauman, Owner, JBS Ventures LLC
• Jeff Francer, Assistant General Counsel, PhRMA

Additional Resources

• Social Media Pharma Marketing Readiness Self-Assessment
  Before you embark on a social media marketing project, it is important that you understand your company's unique regulatory environment, corporate culture, and knowledge, all of which need to be taken into consideration before you develop your plan. Complete this survey and find out how you score compared to your peers.