RTCRM

The internal RTCRM team met last week to discuss changes to the digital pharmaceutical landscape over the course of the year. A presentation led by Director of Interactive Strategy, Carlen Lesser, was attended by members of Account Services, Creative, Interactive Strategy and the Strategy & Insights teams.

We reviewed some key milestones in the past year, including the release of FDA warning letters to Pharma brands for non-compliant banners, search and websites. After discussing the new guidelines (released in May 2009) and the implications for how Important Safety Information is handled through creative and copy, we had a lively conversation about Fair Balance:

Theoretically, the words “Fair” and “Balance” imply a 50-50 split – 50% one thing, 50% another thing. In the case of Pharma marketing this relates to a 50-50 split of benefits versus risks. In the last year it has started to mean 50-50 split of risks and benefits, plus equality of creative and obviousness. We’ve found multiple reasons why Fair + Balance rarely = Fair Balance.

The expectation used to be that TV, print and digital would show a risk for every benefit – to be Fair. TV does it through voice-overs, Print does it by flipping the page, and digital used to do it by dropping Important Safety Information at the bottom of the website. But this really wasn’t that Fair. Why should a user have to flip a page or click around to find the risks, but the benefits get to be front and center and easy to find. That doesn’t seem Balanced. So now the FDA is saying we have to make it more Fair and Balanced by incorporating risks and benefits in the same place. Whenever you cite a benefit of a drug, you need to cite a risk – to be Fair and Balanced. The problem is that while the benefits are usually easy to understand (written by marketers), the risk are usually difficult to understand (written by legal and medical/taken from the prescribing information). So, when you combine something that is easy to understand with something difficult to understand, you end up with something not so Balanced. Not to mention not very Fair to the patient. The FDA also expects that risks and benefits will run in parallel and be related. For example, you might have to state something like, “This drug will help you sleep, but it will also keep you awake”. Well the problem with this approach is that these two may not actually be comparable. If the drug has a 90% chance of helping you sleep, but only a 10% chance of keeping you awake, it would not be Fair to compare them to one another. You would have to find something with a 90% chance of occurring to be truly Balanced.

Clearly the nuances of handling Fair Balance are unique to creative execution, drug indication and medium, but what is unclear is exactly how the new guidelines will improve a patient’s ability to Fairly understand the benefits and Balance the risks.