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Digital Pharma: Counting down to the FDA's social media hearing

Published on 09/11/09 at 10:46am
Dominic Tyer
The #fdasm website
Ignite's informative www.fdasm.com website

Later this week the FDA will hold its hotly anticipated hearing on pharma's use of social media.

The 'Public Hearing on Promotion of FDA-Regulated Medical Products Using the Internet and Social Media Tools', to give its full title, will be held on 12-13 November in Washington DC.

It's the first time in more than a decade that the US regulator has really focused on how the pharmaceutical industry uses the internet and what it should be allowed to do.

Speculation on this side of the pond is rife among digital pharma types as to what it could mean for European pharma - in particular, whether US guidance will become the de-facto rules for companies over here.

Of course the industry in Europe operates within a markedly different environment to companies in the US, particularly when it comes to how it promotes its products and to whom.

Nevertheless, the mere existence of new online guidance - and in the increasingly popular and fast-moving area of social media too - is very exciting, especially as it is unlikely to be replicated any time soon at a European level.

Social media hearing

The hearing will cover the promotion of prescription drugs for humans and animals, prescription biologics and medical devices.

The over-subscribed event - the FDA received 800 requests for the 350 available seats - will see 62 individuals and organisations speak during the course of the two-day hearing.

The agency has invited comments on internet promotion in general, and the use of social media tools in particular. It has also specified five areas to on which proceedings will focus:

• What online communications companies are accountable for

• How companies fulfill regulatory requirements in their internet and social media promotion

• What parameters should apply to the posting of corrective information on third party web sites

• The appropriate use of links

• Online adverse event reporting

The last of these will be very interesting - the issue of adverse event reporting is often cited by pharma as a reason not to engage with social media - and the morning session on Friday will devoted to this topic.

A free live webcast of proceedings will be available, and if you're interested in following discussions on the hearing, before, during and after it happens, then US agency Ignite has put together a very informative website.

After the hearing companies and individuals have until the end of February 2010 to submit additional information, at which point the FDA will get to work producing its guidance - which we may see by the end of next year.

Wendy Blackburn, who is executive VP of digital marketing agency Intouch Solutions, highlights reports on Twitter from the e-Patient Connections conference and quoted the FDA's project manager as saying pharma could "expect guidance by the end of 2010 as a good estimate".

The FDA itself is already using social media itself (even though it has yet to provide the industry with guidance). It has a number of different Twitter accounts and recently used YouTube to highlight Teva Pharmaceuticals' Propofol recall.

Dominic Tyer is web editor for Pharmafocus and InPharm.com and the author of the Digital Pharma blog. He can be contacted via email, Twitter or LinkedIn.

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