10 Jul 2014 Leave a Comment
This Saturday July 12 (9 pm PHT), let’s talk about the FDA’s Draft Guidance for Industry: Internet/Social Media Platforms with Character Space Limitations – Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices at #HealthXPH.
The guidance applies to Twitter and sponsored links on search engines which have character space limitations. It’s an 18-page PDF! Here are the salient parts quoted from the document.
1. Benefit information should be accurate and non-misleading and reveal material facts within each individual character-space-limited communication (e.g. each individual message or tweet).
2. Benefit information should be accompanied by risk information within each individual character-space-limited communication.
3. The content of risk information presented within each individual character-space-limited communication, should, at a minimum, include the most serious risks associated with the product.
4. A mechanism, such as a hyperlink, should also be provided within each individual character-space-limited communication to allow direct access to a more complete discussion of risk information about the product.
5. The prominence of risk information should be comparable to the benefit information within each individual character-space-limited communication, taking into consideration any formatting capabilities available on the specific Internet/social media platform.
I think that’s as specific as it can get. It definitely requires creative tweeting to fit all that required information in 140 characters. @PharmaGuy suggested including a picture in the tweet as a way of complying with the recommendations. Interestingly, tweets with pictures was not discussed in the FDA draft guidance.
Now if you think that these recommendations are difficult to put into practice, here’s what the FDA says -
If a firm concludes that adequate benefit and risk information, as well as other required information, cannot all be communicated within the same character-space-limited communication, then the firm should reconsider using that platform for the intended promotional message.
So here are the topics to be discussed at the #HealthXPH tweet chat:
- T1. Is Twitter with its character limitation, an appropriate platform to advertise prescription drugs or medical devices?
- T2. Has the FDA covered everything in its draft guidance for promotional tweets on drugs/medical devices? Any suggestions?
- T3 Have you seen promotional tweets for drugs/medical devices not compliant with the FDA guidance? If ever, would you report it?
I don’t think there’s an equivalent guidance yet from the Philippine FDA. I am excited to learn what others think in the tweet chat.
23 Jun 2014 Leave a Comment
Day 2! Where’s day 1? I’ll get to that later. Tapping this post out on my iPad while waiting for the next Meet the Professor session.
I stopped by two posters earlier at Hall F.
I met Miriam Padilla: poster SUN-0440 entitled “A novel mobile GIS Platform to build a community-clinical partnership within Boyle Heights, Los Angeles.”
Here’s how I understood this was done. Four young girls participating in a community photography program were asked to take pictures of places within Boyle Heights where they thought health activities were happening. These pictures were uploaded to the website and mapped out using GIS (geographic information system). Interestingly, only 4% of the photos were medical establishments. Clinicians who access the site now have a window to understand the health perspectives of young girls within this community.
I also met Dr. Gloria Wu at poster SUN-0457 – Creation of a new Asian diet smartphone app to target patients with metabolic syndrome and diabetes.
Her group created an app for Asian fast food via a Google search of fast food take menus. The app provides information about calories and glycemic index. Chinese, Japanese and Vietnamese food were included. I asked her if Filipino food can be included in the next version. She also plans to include South Asian food. The app is available on Google Play.