Since November 2009, the FDA has been considering and developing proposed guidance for the use of social media in branded and unbranded communications by regulated entities, such as drug companies and device manufacturers. The FDA had stated that its target for the promulgation of such guidance was by the end of calendar year 2011. Having missed that deadline, and a subsequent promise to publish proposed guidance by the end of the first quarter of 2011, FDA now says it will not set a specific deadline but will instead move as quickly as practicable.
Today, the FDA published in the Federal Register a notice that it is conducting a study to examine “Online Direct-to-Consumer Drug Promotion.” The FDA says the studies are designed to “test different ways of presenting benefit and risk information in online direct-to-consumer (DTC) prescription drug websites.”
It appears the Website study is related to but separate from the regulatory framework the FDA has been considering for the use of social media within a pharmaceutical context.
According to the FDA, “this project is designed to test different ways of presenting prescription drug risk and benefit information on branded drug Web sites”. This research is relevant to current policy questions and debate and will complement qualitative research we plan to conduct on issues surrounding social media.
The original regulations that presently determine FDA’s position on DTC promotion were written at a time when the available media for DTC promotion were print and broadcast, and the primary audience was health care professionals. This dynamic is shifting, and evidence is needed to support guidance development. The series of studies described in this notice will provide data that, along with other input and considerations, will inform the development of future guidance.”
The FDA proposes three studies: