The FDA has issued new draft guidance on how pharmaceutical and medical device firms in the US can talk about their products on social media sites
The new thinking guide which has been published by the FDA means that companies would have to post both the benefits and risks associated with a product, with a link added to a more detailed document on risks.
Although this new guidance may prove difficult to implement on some networks such as Twitter as it allows 140 characters per tweet. Prescriptive medicines with complex indications or extensive risks may have to find other ways to use Twitter. The FDA says that charachter limitations imposed on some social media sites may not provide a meaningful presentation of both benefit and risk. However reminder promotions, where only the name of the product is displayed would be allowed as long as an initial posting did discuss its indication and safety profile.
Wrong information and errors
In the new guidance the FDA has outlined that companies need to seek to correct wrong information posted on external sites such as blogs or those in chat rooms, this may remain difficult to solve as chat rooms and forums are very hard places to monitor what is being posted and said, as it’s normally don’t by instant message.
The FDA does imply though that it would not object if the information on a forum or blog was not to satisfactory requirements however this does not extend to employees of a firm who posted incorrect information.
Neither could a company monitor a discussion on its own website and remove or edit postings that portray a drug in a negative light, while adding comments that portray it in a positive light, it says.
A company may either correct legitimate misinformation directly on the forum, or it may submit the correction to an individual blogger or author of a web page. The FDA says it will not hold a company accountable if a particular author or website failed to correct the misinformation.
If an author disputes the company’s correction about a product’s side effects, for example, a company may respond with specific information from the label.
But if it were to respond with slogans and examples of patient profiles from its marketing campaign, the slogans and patient examples would ‘go beyond providing corrective information’, and thus not be acceptable.
This guidance document comes after discussion on digital issues in January of this year, the aim of which was to make it clear to pharmaceutical companies what they can and can’t say on social media sites when discussing its prescription products.
In the UK there is a lack of guidance when it comes to social networking and digital media, with only basic rules being set in line with European legislation, so this is something that needs addressing sooner rather than later as the world becomes more digital.
In terms of responsibility of these rules very few bodies have stepped forward to say they would enforce them. It is very difficult to create these guidelines as the whole dynamics of social media is constantly changing so rules written for Twitter and Facebook could be completely out of date if new more popular sites come into fruition.
To see the full set of guidelines you can find them here
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