After reading the FDA’s ‘guidance’ I really have to say I am not impressed with this effort. To be honest it looks like a cookie cutter response to questions our industry has had for the past 4 years. I am truly moved by the fact the FDA opened with a disclaimer stating that the guidance provided was not the end-all-be-all to help communicators communicate.
FDA’s guidance documents, including this draft guidance, do not establish legally enforceable rights or responsibilities.
The document has some difficult to digest information regarding the difference between “non-public” and “public”. This means that the document fails to address if information is shared with a patient in a non-public area and that information becomes public. This is very disturbing if you consider the FDA’s guidance that information should be pushed to off label users in ‘private’ communication tools.
The document also has a small example, in line 189, which focuses on how information of a medical nature is presented to potential patients while on a website. The guidance suggests if a website talks about a various disease or condition AND includes items located in a header or menu that a refers to another disease condition a person can misconstrue this as a company endorsing a products use and the company is at fault.
If a firm sets up a website that enables viewers to read prepared standard responses for the firm’s products that are generated from prefixed pull-down menus naming various disease states, including any standard responses related to off-label uses for the firm’s product, resulting requests for off-label information would be considered solicited. Moreover, if this website makes it possible to use search terms to generate standard responses that go beyond the scope of the product information being requested, including off-label use information, resulting requests for and responses to such a search would be considered solicited requests.
The largest portion of the document really focuses on unsolicited, off label requests in a public forum. The document suggests pushing any public forum request, including Twitter, Facebook and forums into a non-public arena like email or a phone call. The FDA’s logic is that since information posted on the internet lives for a long period of time that comments can be posted after a company makes its initial remarks and can be misconstrued as approval of a products use. As a communicator this frightens me because even if information is taken offline there is a good chance that it will end up online.
The guidance also mentions that responses online should be crafted by scientific or medical professionals:
Responses to unsolicited requests for information should be generated by medical or scientific personnel independent from sales or marketing departments.
To be honest this seems almost like a pipedream. I am sure as you know it is hard enough to get researchers or medical professionals to join a meeting let alone respond to an unsolicited request that came through on Twitter.
On page nine, between lines 296 and 327, we see the draft response for what the FDA considers the appropriate level of response. For digestive health I can see the information included in this section to be very important. I struggle to figure out how these responses can be crafted in a public arena considering many arenas have text constraints.
Again the FDA has left us with more questions and put communicators in a place where we are more frightened to respond and help our patient population than before. In the end it looks like 2012 is going to be just like 2011 or 2010. Communicators will clamor to use new tools, legal will push back and both groups will look longingly at the FDA for guidance.