• by Dale Cooke , March 4, 2013

In the pharmaceutical industry, we have become accustomed to a discussion about adopting “risky” communications channels such as social media. These discussions overlook one thing: There are no risky media.

There is no sense in which Twitter, for example, is inherently more risky than a print ad. In fact, no one has received an enforcement action for communications sent via Twitter, but there have been dozens of actions against print advertising, so you could easily argue that Twitter is less risky.

Yet, the myth remains that social media, in particular, and digital tactics, more broadly, represent greater risk and that companies who use these platforms are taking a chance on violating the rules. The most common reason for viewing Twitter and other digital media as inherently more risky is that the FDA has failed to provide explicit guidance about these media. 

It is true that, to date, the FDA has provided only one brief mention of Twitter in a guidance related to responding to unsolicited requests for off-label information, but this absence of more extensive commentary does not make Twitter more risky. Guidance in itself will not guarantee that people will do things correctly, as evidenced by the existing guidance for print ads and the large number of enforcement actions that medium has received.

Instead, the key to using any media compliantly is applying existing regulations to the specific communication. The FDA has made clear through numerous enforcement actions and statements that they do not see any media-specific exemptions to the existing regulations.

There are three keys to using digital media compliantly:

1. Understand the technology

You cannot understand how to use a technology compliantly without understanding the technology, and your understanding has to go far beyond that of a typical user. Veterans of following FDA enforcement actions can easily name specific actions that were most likely the result of people reviewing and approving content without understanding how the technology worked.

2. Review the right material at the right time

No one can determine whether a television commercial is compliant based solely on reading a script. The same principle applies to digital channels. Reviewers must see how tactics will look when functioning, not solely base their judgment on early comps.

3. Apply the same regulations to all media

• Mention of a brand name requires inclusion of the generic.
• Product benefit information requires inclusion of balancing risk information.
• You have to make the product label available. 
• Broadening of a product’s indication is always forbidden.
• All claims must fall within the established label.

Following these principles for developing compliant communications will enable marketers to provide information to people (both HCPs and consumers) in the channels they prefer. As people continue to shift their communications to online tactics, pharmaceutical companies and others who produce prescription products need to adopt these same channels and do so compliantly. Otherwise, they face the far greater risk of becoming irrelevant to people’s health discussion.