Last month saw the conclusion of the FDA’s public hearing on the internet promotion of drugs. This was the first time the agency has directly addressed and engaged key stakeholders in regards to online policy and guidelines since 1996, when the 16.7% of Americans who had web access spent an average of 30 minutes online each month.

While official reports and advice are some time away, a few key presentations and comments have become available online.

It’s worth pointing out that the bulk of these presentations consist of recommendations made by organisations to the FDA for their consideration as part of any new policy.

Nielsen presented in conjunction with the Word Of Mouth Marketing Association (WOMMA) and their podcast with Melissa Davies (Nielsen’s Research Director, Healthcare, Online division) is worth a listen as Davies dissects some of the issues thought to be of major concern in social media, such as adverse event reporting and how patients access health information online.

Also of interest is Davies’ actual presentation and key takeouts regarding these same topics.

As Clinuvel CEO, Dr. Philippe Wolgen discussed a few weeks ago, the FDA’s warning letters spurred a sharp downturn in paid search activity from drug developers, a review of which made it’s way in to Google’s presentation at the forum.  The presentation also includes some recommendations for assisting drug companies to adhere to fair balance language guidelines.

Overall this was an encouraging step by the FDA and a productive forum. We are eagerly awaiting notes and reports due out in the next few weeks, with official FDA guidelines expected by the end of 2010.

Image reference:

While we firmly believe at Clinuvel that communication and online dialogue is a most valuable tool to inform shareholders, prospective patients and physicians, the boundaries of drug promotion are being drawn as we speak.

When it comes to marketing and selling drugs, digital media present the lifescience industry with a plethora of new opportunities. However, the traditional principles of good practice in pharma still apply. In other words, the same guidelines and regulations need to be used when deciding to promote products online. Regulators seem to have followed suit and closely look at online announcements and interpret wording carefully. The best case is presented by the US FDA issuing warnings earlier this year to 14 major pharmaceutical companies in relation to fair balance language and paid search activities.

A key element of drug marketing and advertising in the US is the consideration and use of fair balance language. To explain this simply; terms, conditions and disclaimers must be provided within the context of the advertisement.

Paid search is an effective, popular and targeted marketing channel whereby companies pay to have their advertisements appear in allocated areas of results returned on specific search terms. Most search platforms allow no more than 100 characters in their paid search ads, which is not nearly enough space to allow for adequate fair balance language. Forgoing the use of fair balance language in paid search ads is what triggered the FDA. Campaigns were questioned and halted immediately. Subsequently sponsored link traffic for pharmaceuticals dropped over 80% in four months from nearly 12 million impressions to under 2 million.

The pharma companies involved were not seeking to deceive or exploit their audience, nor taking advantage of ‘loopholes’ in paid search. These entities were simply attempting to market in a popular and increasingly effective channel that has emerged relatively recently. The jury is still out whether the messages were taken too far here. Likewise the FDA is not being heavy handed or over litigious. The agency attempts to properly enforce policy intended to ensure safety and transparency.

It’s exactly this sort of conundrum which has prompted the FDA to hold a public hearing on the topic of the internet and social media next month.

In today’s world of free-flowing conversations, ideas and information, pharma companies must find a way to take part without risking censure, but equally without putting their audience or themselves at risk. The outcomes of the forum are keenly anticipated by drug companies and marketers alike.

- Philippe Wolgen

Reference:

http://www.comscore.com/

http://edocket.access.gpo.gov/

Image reference: