Novartis submitted 6 pages of comments to Docket No. FDA‐2009‐N‐0441 regarding Promotion of FDA‐Regulated Medical Products Using the Internet and Social Media Tools (find it here).
Novartis made many interesting proposals on how FDA should regulate the use of social media by drug companies, but I’d like to focus on one of particular interest to me: special FDA-sanctioned short URLs and hashtags that make it easy for consumers to find product-safety information and for the FDA to review social media communications for compliance.
Novartis first recommended using a “new short URL, essentially a bit.ly for the FDA , that points to drug information on an FDA controlled website… Our recommendation is that the URL include mention of ‘safe’ or ‘safety.’ This website could then contain prescribing information and important safety information wholly controlled and approved by the FDA, removing the need for multiple, additional reviews by an FDA committee of language used on the Internet.” [My emphasis.] Novartis calls this “One review, many uses.“
The second recommendation was for the FDA to consider “establishing a set of search terms that are in the interest of public health and the FDA’s compliance agenda. These terms can be assigned a hastag (‘#’). Widely recognized by Social Media users, hashtags communicate and make it easier for people to find information.”
I mentioned the use of hashtags in my presentation to the FDA during the November, 2009, public hearing: “If each product was assigned a unique hashtag by the FDA and all product tweets were required to include that hashtag, then the FDA, consumers, and healthcare professionals could easily review all the product tweets and ensure they obey regulations regarding fair balance presentation” (see “FDA Social Media Guidelines Best Done in Baby Steps“).
Actually, the hashtag idea was submitted in at least two comments to my survey of readers (see “WANTED: Answers to FDA’s Questions Regarding Pharma’s Use of Social Media“):
“Also, products can be assigned hashtags by FDA, for a Twitter example (eg #Chillax), and be required to use that hashtag in all Twitter communications related to that product, so that FDA can easily review the public tweets. Not sure how the DMs would be monitored. Similar rules for other specific SM sites.” [This comment was submitted by someone who indicated that he or she was “Physician, nurse, other healthcare professional (currently practicing or retired) or medical student”.]
and
“Twitter doesn’t allow for more than 140 characters. Perhaps companies should have a hashtag that can go on the end of tweets. So if a company is having people tweet about a campaign, it would read something like “Great campaign called Cure Diabetes @ (link) #Merckcmpns. “#Merckcmpns would be the hash tag for Merck Campaigns and perhaps audiences would soon learn that these hash tags are equivalent to disclaimers on platforms where more copy is allowed.” [This comment was submitted by someone who indicated that he or she was “Employed at a marketing/marketing research/advertising/communications agency/company/consultancy having pharmaceutical companies as clients.”]
Novartis issued this warning: “Having these search terms added should not, however, be permitted to become an undue burden on the message itself. The benefit of a short message can become somewhat lost if it is buried in a stack of agency-required hash tags.”
