With the deadline for publication of long-awaited FDA guidance on online drug promotion now just 6 months away, 2014 was always likely to be an important year for the nascent sector. And the FDA has got the ball rolling early, posting an unexpected document outlining its views on how and when companies should submit online promotional materials for review.
The guidance isn't the comprehensive policy mandated by the FDA Safety and Innovation Act (FDASIA), but nonetheless gives an insight into the regulator's thinking while clarifying a small aspect of how firms should behave online. In the 7-page draft guidance document, FDA discusses how established rules on the submission of promotional materials apply to blogs, Facebook ($FB), Twitter ($TWTR) and other online platforms.
When companies first release an advertisement in a print magazine or run a television promotion, they are supposed to submit a copy to the FDA. However, as the FDA appears to accept in its new guidance, this model is ill-suited to the world of social media. If companies submitted reports for each of their posts on Twitter, their compliance teams--and the FDA--would quickly be overwhelmed by the paperwork. The rule would likely prove messy and burdensome when applied to social media.
The FDA has instead decided to exercise its enforcement discretion, advising companies to submit a monthly report listing any site on which they engaged in real-time communications, such as Twitter. Other approaches may also be acceptable as long as they make the company compliant with FDA regulations. The rules for sending the FDA static promotional materials--which include emails with predetermined content--remain unchanged.
- here's the guidance document (PDF)
- read Regulatory Focus' coverage
- check out Pharma Marketing Blog's take