Acronym of the week would be more accurate, but GDUFA will be used as a word so it might as well be defined as one. With the passage of the Food and Drug Administration Safety and Innovation Act on July 9, 2012, GDUFA (‘Generic Drug User Fee Amendments...
by Andrew Lamb, Digital Strategist for Healthcare
it falls short of the comprehensive guidance
on social media that many were hoping for, the FDA’s new document on responding to unsolicited requests does have an interest and relevance for those working in healthcare communications on the other side of the Atlantic.
Of course, no digital project is completely ‘local’ and Europeans should always have half an eye on developments elsewhere in the world. More importantly though, the FDA has given us a useful clue to what regulators are thinking and the issues they face in coming up with clear rules for the rapidly evolving environment of the web and social media. It could also set the tone for European guidance, if and when it appears.
The most significant aspect of the FDA’s new document is that:
- It seems to tacitly acknowledge that pharma companies might legitimately have social features such as forums on sites they manage or own, or have a presence on other social media services such as Twitter and YouTube (these are mentioned by name).
- Interestingly, it also seems to equate a question asked at a meeting with a question asked on the Internet, saying that they are both examples of ‘public unsolicited requests’.
Suggestive as these elements are they do not amount to firm guidance on how the pharmaceutical industry should behave online. Such guidance is similarly lacking in Europe. In the UK, for example, the Association of British Pharmaceutical Industries (ABPI) code has only a short section on the Internet, and while the Prescription Medicines Code of Practice Authority (PMCPA; the body that administers the code) has issued a Q&A on using digital tactics in an adherent manner, this is very broad. It leaves many questions unanswered around such hot topics as pay-per-click advertising, the use of Facebook and other social networks, and the monitoring of adverse events during ‘social listening’ exercises.
The charm and the power of the Internet lies in its unregulated, fluid, constantly evolving nature, and in such a medium it’s not always possible or easy to control who sees content, or how it is shared and reused. Every day new ways of communicating emerge, and therefore new challenges for those looking to stay within the various codes that govern the pharmaceutical industry.
So while regulators are essentially trying to hit a moving target, healthcare communicators are best served by ensuring they adhere to the spirit as well as the letter of the codes that do exist – whether in Europe or the USA. These restrictions, and the uncertainty around social media, will probably stifle innovation, but even so we should not use them as an excuse for failing to develop new ways of communicating that both serve our client’s business needs, and delight the people who use them.
We capture the opinions and insights of several of our employees on a variety of communication topics about Healthcare.