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FDA’s guidance documents, including this draft guidance, do not establish legally enforceable rights or responsibilities.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.
