While FDA’s Division of Drug Marketing, Advertising and Communication does what it does with respect to developing some regulatory policy on the Internet over the course of many years, in Britain with new guidance on pharmacovigilance due in 2012, the medicines trade association has produced some material to try to move the discussion further along in that country.
The reporting of adverse events discovered through the discourse of social media has long been the bogeyman feared by the legal and regulatory departments of drug manufacturers in the U.S. The result has been that the industry that manufactures medicines has been reticent from participation in social media channels – and must be circumspect with regard to its Internet activities. The irony of course is that seeking health care information on line is a primary reason people go to the Internet. The FDA began looking at the Internet in 1996. They are still looking….
In fact, however, the adverse event issue may have proven a red herring. That is perhaps evidenced by the now large number of Twitter feeds that are active representing pharmaceutical manufacturing companies companies and even their products; the growing, though not as quickly and not with as much success, presence of YouTube channels; the large number of Facebook pages and even an uptick in the number of corporate sponsored blogs – now at five by my count. If the adverse event reporting issue really were an issue, this presence would be shrinking, not growing.
On the subject, the Association of the British Pharmaceutical Industry (ABPI) – a trade association in Britain that is roughly the equivalent of the Pharmaceutical Research and Manufacturers of America (PhRMA) has issued a white paper entitled “Pharmacovigilance and the Internet: A Call for Change” as well as guidance in the form of a paper entitled “Guidance Notes on the Management of Adverse Events and Product Complaints from Pharmaceutical Sponsored Websites“.
The white paper is an attempt to call attention to the need for the subject of digital media to be included in the upcoming pharmacovigilance guidance expected in 2012. The profession association “has become increasingly concerned that the complex regulatory requirements for pharmacovigilance, brought in to protect patients at a time of information scarcity, are now acting as a barrier to the use of this information as an important additional resource to protect public health.”
The guidance itself is demonstrative of some of the challenges that DDMAC faces in developing its own regulatory guidance. It is difficult not to be platform specific -and developments such as the one to occur in August with Facebook no longer allowing commentary to be closed – occur quickly and have enormous effect. The British industry guidance calls for some principles – such as transparency – and delineates some recommendations in three categories – (i) listening in; (ii) giving out and (iii) engaging with.
That is a limited framework and needs added to it the biggest question – one bigger than the adverse event issue – the question of third party sites and correction of third party material – i.e., Wikipedia. However, adding that fourth category to these three may provide a framework for DDMAC to do its work.