Comments from Novartis, Eli Lilly and Pfizer revealed that industry is taking serious issue with some aspects of the draft guidance from the US FDA on social media and promotional materials online.
All three drugmakers focused their critiques on the Food and Drug Administration’s (FDA) authority, as well as specific aspects of the draft dealing with the placement of ads on websites and the tracking of such promotional content.
Pfizer said the FDA “does not have any general authority to regulate promotion” as the agency can only regulate what constitutes “labelling or advertising.”
Final guidance should confirm that “firms are not responsible for and need not submit other pages within a third-party website that are independent of the page or pages that the firm controls,” Pfizer continued.
The company also said the FDA has not adequately demarcated the two separate categories of promotional materials that fall under pharma’s control, and calls for three distinct categories:
- Sites that are owned, created, controlled or operated by the firm;
- Certain third-party sites, which require further clarification from the FDA; and
- Employees or agents acting on behalf of the firm to promote products online.
Pfizer agreed with industry groups BIO and PhRMA that control over third-party content should hinge on whether the company actually controls the content and surrounding pages.
Similarly, Novartis took issue with the way the FDA phrases its statements on the placement of promotions on a website. Novartis offered examples of when it might be appropriate to direct a site to display certain promotional materials alongside relevant content.
“FDA should encourage firms to place product promotion on third-party sites responsibly and locations within those sites where an appropriate audience would be most likely interested in learning about a particular product,” Novartis said.
The company went on to echo Pfizer in calling for firms to only be “required to submit the pages surrounding their product promotion…if they had direct control or influence (e.g. authorship or editorial control) over the content appearing on the surrounding pages.”
Lilly, meanwhile, criticized the agency over the tracking of such third-party sites, arguing that maintaining “monthly notifications of an inventory listing for each location of promotional content is unduly burdensome for FDA and for manufacturers.”
Lilly instead called for annual notifications, with further notification prior to the initial display of promotional material on an interactive site. The company also asked for a more reasonable timeframe for informing the FDA when promotional material is taken down from a site, calling for a month of inactivity to spur the correspondence.
But the comments weren’t all negative as all three drugmakers commended the FDA for issuing the draft guidance and providing an early framework for how interactive media should be regulated