Andy Levitt, Founder and CEO of HealthTalker, and Tony DiResta, WOMMA’s General Counsel, both wrote perspectives on the Guidance. Snippets are below.

For the full posts, visit All Things WOM and DiResta-the-Law.

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HealthTalker Thoughts on the FDA’s Social Media Guidelines

By Andy Levitt, Founder and CEO of HealthTalker

Many people in the pharma world have been champing at the bit for the FDA to provide guidance on how to use social media in the promotion of prescription products.

For what it’s worth, I think that the use of social channels in the Rx space is widely over-hyped, and that the real opportunities lie in old fashioned, face-to-face word of mouth dialogue.  (Disclaimer: my company, HealthTalker, provides WOM services for life science companies).

Manufacturers and many of the agencies that support them have wondered how to avoid regulatory headaches but still tap into the power of Facebook, Twitter and the like, hoping to strike gold with these dynamic channels leading to noteworthy promotion and increased market share.

I actually find the whole thing a bit laughable as it suggests that people in the industry have become too afraid to think on their own, to apply good judgment to marketing and promotion, and to push the envelope a bit further.  That statement might anger some people and offend a few more, but at the end of the day the FDA will never tell us exactly what to do; they will only provide draft guidance.

Continue Reading…

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The Attorney’s Perspective on the FDA Guidance

By Tony DiResta, Partner at Winston & Strawn LLP and WOMMA’s General Counsel

Over 2 years ago, the Food and Drug Administration (FDA) held hearings on the use of social media for pharmaceutical advertising.  WOMMA representatives provided testimony during those hearings.  Comments concerning issues presented by those hearings were provided by many industry groups, including WOMMA.

Anticipation has been great, with the expectation that clarity would be provided for pharmaceutical companies desiring to use social media platforms as part of the educational and promotional activities.  After years of waiting by the pharmaceutical industry, the FDA quietly released its “Guidance for Industry Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices” in the Federal Register.  Unfortunately, the agency declined to provide detailed instructions and rules.

Continue Reading…

Three Main Points:

1. Responding to Misuse – A major issue keeping Pharma brands away from social media is the sheer volume of incorrect product information shared online. The new guide acknowledged the need for brands to respond. If asked in a public platform, brands can respond with company contact information. It takes the discussion offline while still addressing the customer’s query.

2. The Truth Prevails – The FDA found Pharma brands to be capable of responding to requests about their products “in a truthful, non-misleading, and accurate manner.”

3. Pharma as Thought Leaders – Now empowered with the freedom to respond to public queries, the FDA saw this as an opportunity for Pharma brands to help lead the general healthcare conversation in the US.

Key Takeaway: By freeing up Pharma to engage with public commenters, the FDA has opened an excellent opportunity for Pharma to expand their word of mouth marketing operations.

Read more about the report at Radian6

WCG Creates a Fake Pharma Brand as an Example

Testaquel, a fake drug, shows how the Safety Information page works.

AstraZeneca Stays on Facebook

They explain why here.

InPharm Discusses Comment-Enabled Pages

Pfizer keeps some of their pages up and nixes others.

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Learn more about healthcare in social media in our WOM-COMM Healthcare Certificate Program

This is a quick and dirty summation of Facebook’s new rules. To learn more, please attend next week’s free webinar on the subject: What if Facebook Turns on Comments?

Speakers:

• Peter Pitts, Senior Partner, Director Global Regulatory & Health Policy, Porter Novelli

• Brad McCormick, EVP, Global Digital Director Porter Novelli

Wed., May 25^th

5:00 pm ET/4:00 pm CT/2:00 pm PT

Register Here

ROI Demystified

Coca-Cola, Escalate & ChatThreads

WOM in the Pharma Industry

Shire Pharmaceuticals & HealthTalker

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This is WOMMA member exclusive content. For more info on becoming a member, contact Jason Dent, our Director of Member Development, at JasonDent@WOMMA.org or 312-853-4400 x201.

1. Safety First - The FDA clearly stated that their mission is to ensure consumers receive accurate information and aren’t exposed to unsafe products. There weren’t many specifics on how media will be monitored to ensure this.

2. Do as I Say, Not as I Do - The FDA will expand their use of social media to disseminate their messaging.

3. Focus on Misleading - No matter what the medium, misleading information is a very serious matter for the FDA.

Read more about the document at Fresh Influence

Key Takeaway: Consumers use the internet to answer their health questions. The industry must start working on solutions for engaging.

Read more about the state of pharma & the internet at Edelman Digital

Who the proper authorities are is not clearly defined, but this stipulation also misses one of the key tenets of social media: open discussion naturally self-regulates. With many healthcare and pharma professionals waiting for the FDA to release solid guides on Web 2.0 conduct, this policy serves as a good first step.

We want to know what you think. Please take a look at the policy and comment below.

Read the full cited post at the Pharma Marketing Blog

Andrew Levitt is the Founder & CEO of HealthTalker, a word of mouth agency that specializes in the healthcare industry. He will present at WOMMA Summit 2010, Nov. 17-19 with his client Shire Pharmaceuticals on their case study of a year-long program that drove conversations, insights and motivation for ADHD solutions.

What approach to WOM should Pharma brands take?

It’s really important for Pharma companies to understand and outline the goals and objectives that they have for a WOM campaign and recognize that it is likely not a silver bullet but rather can serve as a really nice complimentary approach to other marketing tactics. It needs to be treated as a distinct and unique marketing tactic that has potentially different outcomes, calls to action, or lifecycles than other forms of media. It should be looked at with the intent that WOM should become part of the DNA of how these brands market themselves by tapping into the power of the consumers that are passionate about the products and conditions that they’re treating.

What are the specific challenges that Pharma encounters when the enter into Word of Mouth and Social Media?

There are a few things that I think cause them the most concern. Since so much of the Pharma industry is based on controlling the message, they are worried about a lack of control. There’s good reason for that because it’s a highly regulated industry. But a company needs to be able to embrace the fact that they should let go of some of that control in order to enable people to have conversations. With that said, there are obviously certain ways that that can be accomplished that doesn’t put a company at risk. If they use some smart approaches, we can help those companies structure programs to do just that.

Another key thing that they’re concerned with is the burden of potential adverse events reporting. As drug companies do more to enable a two-way dialogue and no longer just push out messages and content, but instead opening themselves up to capture real feedback from their customers, there’s the chance that they’re going to hear stuff that they don’t necessarily want to hear about. There’s a burden requirement of reporting. Because they may not totally understand how a program can be structured to fulfill the reporting requirement, it causes them concern to think of what the potential impact or fallout could be.

Whether that’s valid or not, whether there would even be adverse events reported, whether people would be talking about their drug or just a condition to raise awareness, the potential for hearing about those adverse events exists. Those are the issues that require a little more discussion and intelligence to go through a process to understand how to structure something that can work in the industry.

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Summit 2010 is full of great speakers like Andrew. Learn more and register here.

Our friend John Fitzpatrick of WOMMA member HealthTalker attended School of WOM this week and blogged about his takeaways. As one of the few pharma marketers there, John had a unique perspective on what he saw and heard at the conference.

Read his takeaways at HealthTalker’s blog, Small Talk