Are biotech brand managers Waiting for Godot?

No need to wait—The FDA has already provided guidance.

In Waiting for Godot, a play by Samuel Beckett, two characters wait endlessly and in vain for someone named Godot to arrive. Are you similarly waiting for the FDA to issue guidance on social media activities? It could be an endless wait!

A recent search of Warning Letters illustrates this point. In March 2009, the FDA issued a Warning Letter concerning a banner ad. The FDA has made a few comments regarding websites since then, but nothing else about banner ads, even though manufacturers continue to use them to promote their products.

Many industry experts believe that the FDA won’t make a distinction among various mediums. It won’t matter to the FDA if your claims appear in a printed sales aid, product website, bus wrap, or banner ad. What’s important to the FDA is content. Balanced content.

We all know the rules for promotional messages that appear in print. Claims and fair balance must be treated in the same manner with regard to placement, color, font, and size. In its May 2009 draft guidance document on presenting risk information, the FDA states, “Format includes the shape, size, and general layout of all portions of a print promotional piece, as well as the general plan of organization, arrangement, and theme in non-print promotional pieces such as videos and broadcast ads.”

Aren’t banner ads and websites non-print promotion?

See what I mean about our already knowing the rules?

Usually, in their Warning Letters regarding print or broadcast ads, the Division of Drug Marketing, Advertising, and Communications (DDMAC) cites a pharmaceutical company for misleading promotional materials that:

• Broadens the indication
• Overstates efficacy
• Presents unsubstantiated superiority claims
• Omits serious risks associated with the drug
• Uses format that isn’t consistent with the presentation of benefits

In reviewing the banner ad that I mentioned, the FDA cited the last two bulleted items. The Warning Letter was issued to GlaxoSmithKline (GSK) for its migraine medication, Treximet™ (sumatriptan and naproxen sodium) Tablets. The FDA reviewed five banner ads and found that “The online banners are misleading because they minimize serious risks and inadequately communicate facts material to the presentation about the drug.”

See what I mean about our already knowing the rules?

The Warning Letter continues, “The banners fail to communicate the serious risks associated with Treximet with a prominence and readability reasonably comparable with the presentation of information related to effectiveness.

“Specifically, these banners, although varying in exact dimensions, present efficacy claims prominently, utilizing techniques that are designed to emphasize this information, but relegate the presentation of risk information to a small, scrolling portion of the banner that is likely to be ignored by consumers.”

Now that we know the rules, we can play the game. At least until the FDA tells us otherwise!