Healthcare marketers have long awaited guidance from the FDA on how to engage online without violating patient privacy. The wait ended recently when the FDA released the “Guidance for Industry Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices.”
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and offend a few more, but at the end of the day the FDA will never tell us exactly what to do; they will only provide draft guidance.
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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.
