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Digital Pharma: FDA listens on social media

Published on 16/11/09 at 10:13am
Dominic Tyer
FDA's Twitter account
The FDA's Twitter account was part of the promotional efforts for the social media hearing

The FDA's last internet-related hearing took place more than ten years ago in 1996, a time when its concerns centred around chat-rooms, newsgroups and website links.

You hardly need to be a digital aficionado to appreciate just how far today's web has changed since then, and it was no surprise to find Web 2.0 tools like Twitter and Google sidewiki among the topics covered at last week's FDA social media and internet hearing.

Only four pharma companies to put their heads above the parapet on the day, but many, many more were monitoring it live over the internet, whether via Twitter or the FDA's webcast.

The two-day hearing was just the start of a consultation period that will last until February 28 2010, so it's a fair bet that firms like Merck, GlaxoSmithKline and Novartis will opt to make written submissions, having first seen how the initial stage progressed.

But on the day it was down to Pfizer, Lilly, Johnson & Johnson and Sanofi-Aventis to put across an industry view.

Collaboration, control and clarity

First up was Michele Sharp, Lilly's senior director of US regulatory affairs, who said she wanted to see a more collaborative approach to social media between pharma and the FDA.

"At Lilly, we believe we can and should play a significant role in providing patients not only pharmaceutical solutions, but information and support to help them make healthcare decisions that will have a positive impact on their lives.

"To be successful with this vision, we must be visible and relevant in the places where patients, physicians, caregivers and payers are looking - where they are searching for, obtaining and sharing information on diseases and treatment options. These days, that includes the internet and social media."

She called for the FDA to lead a series of public workshops to work towards solutions to the existing issues and, noting the rapid pace of in the online space, also set up ongoing working groups to address emerging issues and technologies.

Johnson & Johnson too wanted more opportunities to use technology to help people access accurate, timely and credible information, a sentiment echoed towards the end of the hearing by Pfizer's Clifford Thumma.

Johnson & Johnson also said it did not want to be held accountable for policing the whole of the internet, perhaps alluding to the threat posed by Google sidewiki, which allows any user to add any comment to any website.

The company's presentation, summarised on its JnJBTW blog (itself a recent sidewiki target), also called for clarity from the regulator on healthcare companies' use of social media.

The issue of just what pharma can control, and what should be considered outside its remit, was a feature of US industry association PhRMA's presentation.

"Manufacturers are unable to monitor every web site, blog, or chat room for adverse events, but they can monitor sites that they control. Adverse event reporting should be based on the same criteria required to submit reports found in other media: an identifiable patient, an identifiable reporter, specific use of a drug or biologic, and an adverse event."

The body also floated the idea of an FDA-approved 'kitemark' for sites that provide regulated risk-benefit information.

This would see either the FDA's own logo or an FDA-approved image appear in search results and across the web to inform patients, at a glance, that they are visiting a legitimate site.

"Such a graphic symbol could be combined with a universal warning statement to provide an indication of risk when there is little space (for example, a search result or tweet)," said said PhRMA's senior vice president Ken Johnson.

But this doesn't seem to really address the issue at hand, namely how should pharma use social media, instead reminding me of the Health On the Net code, which has been around since 1995.

A digital milestone for pharma

But the very fact that last week's hearing was held at all, and that a major regulator acknowledged the existence of social media and the need for pharma guidance made it a real milestone for the industry.

And as more and more internet-savvy patients and healthcare professionals emerge, the FDA's guidance when it comes will have an increasingly important influence on the way industry operates in the future.

One way or another there will also be repercussions for European pharma as US guidelines will at the very least shape social media use over here and could have a greater impact.

The FDA has already flexed its muscles over online materials created for a non-US audience - one major European pharma company received a written request to change the disclaimers shown on all its websites, irrespective of where the target audience actually lived.

But whatever the impact of FDA guidence, the only thing we can count on is that the regulator is never going to move as fast as those involved with social media and online initiatives would like.

For the time being the next stage will be when transcripts of the hearing are made available online, which will happen approximately 30 days after the hearing.

Then, when the February 2010 submissions deadline passes, the earliest that guidance is likely to arrive is the end of 2010, at which point we'll be able to see how much of a milestone last week's hearing really was.

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

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