In its efforts to rein in drug advertisement in the digital age, FDA has published several guidance documents and rules to clarify and advise about acceptable marketing practices.
There is a guidance on use of
website content and twitter among others that advise about FDA’s expectations. However, there is little advice from FDA about adequate digital ads such as those on Google search engine. At the same time FDA has been taking action against companies it deems to be practicing unacceptable digital advertisements. The first such action by FDA was in March 2009 when FDA sent simultaneous Warning Letters to 14 companies for illegal digital ads for 48 products. These letters explicitly referred to SEM ads running on Google, and one cited organic search listings on Yahoo! The violations identified included omission of risk information, overstatement of risk, using misleading or inaccurate product name, and not identifying the indication properly. At that time, drug companies pretty much stopped using SEM ads. But over time, the drug companies found a way to be compliant by using Reminder ads and Redirecting ads. However, there are increasing concerns about the compliance of these digital ads as well. To address the concerns, Google announced two significant changes this week to the way paid search engine advertising works for pharmaceutical products. The first change affects only black box drugs and will take effect beginning July 20, 2015. The second affects redirecting ads and will take effect in January of 2016. This is to be compliant to the FDA guidance on online ads with
limited space setting. Under the
new policy, starting 20 July 2015, Google will require all drug ads to follow the standard ad format which will include the brand and generic name as well as a “Please see” statement directing users to the full PI including boxed warning. Starting January of 2016, Google will not allow any redirected ads for drug ads. These policies will apply to all drugs, biologics and medical devices regulated by the US FDA, and will be Google worldwide policy for such ads. This is bound to update all SEM ads for drugs. It is also expected to affect ads placed on other search engines such as Yahoo and Bing.
