On June 27, FDA approved a new product – a rapid acting inhaled insulin indicated for the treatment of diabetes call Afrezza. The agency announced the approval by sending out a press release. The agency also sent out this tweet:
Note that the agency sent out the tweet announcing the product name and the indication. The generic or chemical name is not included, nor is there any risk information.
Also in June, FDA released some long awaited guidance documents, one of which addressed how companies can communicate about their products where there is a character space limitation, such as on Twitter, where 140 characters are the maximum allowed. That guidance document enunciated FDA’s principles related to pharma communications about a medicine on a communications platform where there are character limitations and then provided a hypothetical example of a company’s tweet about a drug. The drug was called NoFocus (remembering Hydrochloride) and it had a rather benign risk profile associated with it.
Here are some (but not an exhaustive, all inclusive list – for the complete set, see the Guidance Document) of the guidelines included for consideration when operating in a space with character limitations:
- In general, benefit information should be accurate and non-misleading and reveal material facts
- Benefit information should be accompanied by risk information that should be presented together with benefit information
- The content of risk information should, at a minimum, include the most serious risks associated with the product
- A hyperlink should also be provided to allow more direct access to risk information (there are further details regarding this use included in the guidance)
- Prominence of risk information should be comparable to the benefit information
- Firms should communicate both the proprietary (trade or brand) name and the established name
As seen from a slide in FDA’s Webinar on its social media guidance, the tweet that FDA designed for the company that makes NoFocus apparently compliant with FDA’s guidelines respecting the character space limitation of a tweet came out to be 133 characters and is located in blue box below.
If one compares the tweet that FDA designed for a company talking about its own medicine and compares it to the tweet sent by FDA about a product approval, one is forced to ask two questions:
- With all of the structure laid on a company’s tweet which apparently does not apply to FDA, could a company re-tweet the news sent out by FDA on its twitter feed? My interpretation would have me answer “No”.
- If the point of the FDA regulations is to protect the public health, why does a tweet from a company carry so much more restriction than one from FDA? What is the public health interest here? In it’s Webinar presentation regarding character space limitation, FDA included a slide entitled “Importance of this draft guidance” that told us that the guidance “advances FDA’s mission in protecting public health – regardless of the platform, truthful, accurate, and balanced product promotion best serves the public.” Lacking in that slide, or anywhere in the presentation however, is any insight into how this guidance achieves that aim or exactly what the public health interest is that is being protected by all of the requirements placed on industry speech where there is a character limitation. We are left to speculate.
Under FDA’s guidance on use of character space limitation platforms would seemingly make Twitter unusable for a branded tweet unless one simply wanted to tweet an advertisement, which is what the NoFocus example essentially is reduced to. But Twitter is a news platform and the restrictions FDA has placed on companies has stripped away the possibility of adding to the structure laid out in the NoFocus example with any additional news once one has satisfied all of the regulatory requirements. Fortunately for patients seeking news and information about a product, FDA is not so constrained when it sends out news of its own.
On the blog site, there is a tab that contains many resources related to the regulation of social media by FDA.
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