FDA draft social media guidance for off-label information
09.01.12
Two years after carrying a major public hearing on the topic, the FDA released a new draft guidance that offers recommendations to companies wishing to respond to unsolicited for off-labels information, including requests made via social media websites. The guidance is entitled Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices. The agency seeks comments on the draft guidance by 29 March 2012.
This draft guidance addresses how firms should respond to solocitated and unsolicitated requests for off-label information that occur in public forums, including the internet and electronic social media.
This guidance is an important step. It shows the US regulator is paying attention to the impact of Social Media in healthcare.
In Europe, there are still few guidelines on the topic. Some organisations, like our sister association, ABPI, are being proactive in setting out some framework. Indeed, last June they published the following guidance: Guidance notes on the management of adverse events and product complaints from pharmaceutical company sponsored websites.
However, there is still a need for clarity on this topic.
For further information, read this good coverage here at Pharmalot.
