FDA publishes ‘new thinking’ on social media use
pharmafile | June 18, 2014 | News story | Medical Communications, Sales and Marketing | ABPI, FDA, Facebook, Twitter, social media
The FDA has issued new draft guidance on how pharmaceutical and medical device firms in the US can talk about their products on social media sites.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 proposal would essentially mean that companies would have to post both the benefits and the main risks associated with a product, with a hyperlink directing the reader to a more detailed risks list.
As an example the FDA used a fictional memory loss drug called ‘NoFocus’, saying an acceptable tweet about this drug could read: “NoFocus for mild to moderate memory loss; may cause seizures in patients with a seizure disorder www.nofocus.com/risk”.
This means the firm tweeting about the drug would have to put in its full indication – it could not just say it was for memory loss, as this could be misleading.
For some products however, the limited space on media such as Twitter (which only allows 140 characters) may prove more difficult.
This is especially true with prescription medicines with complex indications or extensive serious risks, as many treatments now have. The FDA says that “character space limitations imposed by platform providers [such as Twitter] may not enable meaningful presentations of both benefit and risk”.
But it does say that simple ‘reminder promotions’, in which only the name of the product is displayed, would be allowed, as long as an initial posting did discuss its indication and safety profile.
Misinformation and errors
The FDA also outlined proposed guidance for companies seeking to correct misinformation posted by external writers such as bloggers or those in chat rooms.
The agency said it would not require a “full balancing of risks and benefits” that are normally required, as long as the corrections are “clearly defined, accurate and not misleading”.
“The FDA does not intend to object if the corrective information does not satisfy otherwise applicable regulatory requirements regarding labelling or advertising,” according to the guidance.
This would not however, 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 latest guidance comes after the FDA began a consultation on these digital issues in January this year, the aim of which is to make it clear just what pharma can and cannot say on social media sites when it comes to discussing its prescription products.
The US regulator says this is not legally binding however, but rather shows its ‘thinking’ on these issues.
Drip-feed guidance
The FDA has for many years been attempting to form a set of coherent digital guidance for the industry but the process has been slow, with only a drip-feed of guidance coming from the regulator over the past few years.
In the UK digital guidance is also lacking, with only a basic set of rules in line with European legislation currently available.
Very few bodies want to take responsibility for this area and in an interview with Pharmafile earlier this week, the ABPI’s new president Jonathan Emms says that it is difficult to create such rules – as new media such as Twitter and Facebook could be replaced with new sites that would require an entirely new set of rules, making it difficult to keep up.
The ABPI has said in the past to Pharmafile that it is considering whether or not it should take responsibility for digital rules at all, given the cumbersome nature of producing guidance. It acknowledges, however, that this is an important area for pharma in terms of communication.
Ben Adams
Related Content
MRM Health’s ulcerative colitis treatment receives FDA Investigational New Drug clearance
Microbial Resource Management (MRM) Health has announced that its lead programme, MH002, has received Investigational …
Complement Therapeutics’ geographic atrophy treatment receives FDA Fast Track designation
Complement Therapeutics has announced that CTx001, its gene therapy treatment for geographic atrophy (GA) secondary …
Johnson & Johnson submits robotic surgical system for De Novo classification
Johnson & Johnson has announced the submission of its Ottava Robotic Surgical System for De …
