DDMAC will hold a public hearing in November to discuss the protocols of internet drug marketing and promotion.
The hearing will address online bogeymen such as adverse events reporting, off-label discussions and the presentation of risk information, with an eye toward the creation of formal policy guidelines, according to an announcement in the Federal Register, beginning on page 48083.
To get the ball rolling, DDMAC named five areas for discussion in the announcement, including the extent to which manufacturers are accountable for product information online, how fair balance information should be presented in light of space limitations, the parameters for correcting inaccurate product information, the use of links and the reporting of adverse events.
DDMAC reiterated its past position in the announcement – that existing regulations can be used to assess the legality of online promotions – but admitted that “the internet possesses certain unique technological features, and…some online tools that may be used for promotion offer novel presentation and content features.”
Manufacturers and their agencies have been asking DDMAC for guidelines on emerging digital media for years, and a flurry of industry tweets and blog posts heralded the announcement this morning. Fabio Gratton, chief innovation officer, at Ignite Health, was pleased by the amount of detail provided by FDA. “They've not only done their research, but clearly they've spoken to industry people about the most pressing issues,” he said. Gratton plans to attend the hearing in November, and is currently working to organize marketers and other interested parties online.
The public hearing is scheduled for November 12 and 13 in Washington DC, and FDA is seeking participation from “consumers, patients, caregivers, health care professionals, patient groups, internet vendors, advertising agencies, and the regulated industry,” according to the announcement. Formal policy and guidelines aren't expected from DDMAC before next summer. FDA representatives were not immediately available for comment.