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Last month, the FDA held open hearings to debate the topic of social media guidelines for the pharma and biotech industry. I was following from afar on my iPhone at the NY Chemotherapy meeting, as this was the first such hearing since 1996 and many in the industry were excited that the FDA at ,east appeared to be listening and finally getting social media.
- There were a lot of agency people presenting (some argued they had a vested self interest)
- Not many pharma people were actually presenting (despite griping about the lack of guidelines in this space)
- Not many patients or patient advocacy groups were involved either.
What was also interesting was that there was plenty of justification for the use of social media, but very little in the way of practical solutions and suggestions that the FDA could consider, thus speeding up the process.
In the past, the FDA have claimed that it is all about the message not the medium, witness sending 14 pharma and biotech companies letters back in April this year for their Google ads with 1 or 2 clicks from the full safety information. However well intentioned the wrist slap was, it ws later shown to negatively affect public health, as some of the presenters at the meeting clearly showed.
Rather than look at this incident negatively, I wondered if the respectful and interesting interactions between the FDA DDMAC and industry seen at the hearings could not continue in the same vein on a more frequent basis. Dialogue and discussion make for much more constructive rather than destructive relationships.
There are several things I'd like to point out about safety and adverse events (AE's):
- They happen, no drug is immune from them, so best not to avoid them
- Have policies and procedures for easily recording and submitting AE's
- The currernt MedWatch reporting system is awful and cumbersome to use
- If there was a better system, more doctors and patients would be more likely to report them
- Social media could be a great tool for improving the MedWatch system, reaching more people, more easily and collating the relevant information
What was particularly poignant about these hearings is that, for me at least, a great chance was missed to put patients front and centre, whether this was in the form of better public health information and education or looking at ways to improve clinical outcomes.
Are patients really out of sight and out of mind?
The FDA will still be collecting comments and suggestions until February 2010, so if you missed the hearings this month, please do take the time and contribute offline. The link to the FDA is here type in FDA-2009-N-0441 in the search box and it will bring up the dockets for comments.
In the meantime, John Mack of Pharma Marketing News is also running an anonymised survey to gather feedback and further suggestions post meeting and will send the aggregated results to the FDA. Click here to make your views known!