As we wait for the official word from the FDA on how the DDMAC guidelines should be applied to the digital space, we can learn how the FDA is interpreting the use of social media for promotional activities through their warning letters. Novartis Pharmaceuticals Corporation (an Edelman client, though not for this particular promotion) recently received a warning letter that covered, among other infractions, the use of the Facebook Share widget on their product website for TASIGNA (nilotinib).
Our digital health team is well versed on the regulations pharmaceutical and device manufacturers must abide by and how to leverage the benefits of social media while following DDMAC guidelines, and looking at the letter, here are some key points to remember.
Submission of Materials
One of the violations the warning letter addresses is the failure of Novartis to submit promotional materials 30 days prior to use as required for TASIGNA under the Subpart H regulations. Depending on the FDA approval of the product, the company must submit the promotional materials prior to use or upon launch of the promotion. This is true for digital or non-digital promotions.
Fair Balance
In April 2009, the FDA sent letters to 14 pharma companies about branded paid search advertising. From that, we learned it is not deemed sufficient to have the fair balance information one click away. The recent warning letter to Novartis also mentions this issue. As a reminder, anytime the product is mentioned with its indication, or anytime a claim is made, the safety information must also be presented.
Unsubstantiated Claims
Whenever a claim is made, such as “Product X reduces Symptom Y by 50%” or “Product X is more effective than Product Z,” the company must have data to support the claim. The recent warning letter notes that the copy Novartis used to describe TASIGNA as a “next-generation treatment” is misleadingly suggests superiority over other treatments in the category. This guideline is true for digital or non-digital promotions.
Sharing
This warning letter is a bit different than those in the past because it implies that the use of social media tools by individuals – in this case, the Facebook Share widget – is considered promotional. In the past, one person telling someone about a drug they heard about/saw an ad for/took wouldn’t really be a matter for the FDA. With this warning letter, the FDA is considering providing the potential for the consumer to take “sharing” action as DTC promotions on behalf of the organization. The concern here is that in typical bureaucratic fashion, the warning letter is massively overbroad. Rather than addressing the specific issue – which is failure to include risk information – it calls into question the whole mechanic of information sharing.
What Does This Mean For Me?
In the absence of official guidance from the FDA on the digital space – which we anxiously await – we must ensure that any communications programs we plan or implement for our regulated clients follow the existing DDMAC guidelines. When considering a “Share” functionality, we can use only unbranded information or – if possible – ensure that the appropriate safety information is included in the copy that will be passed along.
Add your thoughts about this recent warning letter and the challenges the industry faces in the digital space by commenting on this Check-Up.
