As promised, the major focus of my blog this year will be the subject of healthcare marketing, especially its legal and ethical implications.

When I was writing my innaugural message on Standing Up to Healthcare Marketing Hypocrisy, I noted a post on John Mack's blog discussing the "death of one-click rule" . Today, I am going to highlight this action by FDA as an example of what is wrong with applying traditional media regulations online.

The issue at hand: should banner ads include drug warnings?

According to the precedent set by the latest FDA action now they just might have to. Novartis, the maker of Diovan received a "warning letter" objecting to banner ads that did not include sufficient warning information about drug's side effects. Remarkably, FDA letter objected to neutrally-sounding language of the ad. Decide for yourself whether these messages go overboard in promoting the drug:

• "Ask your doctor how Diovan can help lower your blood pressure"
• "High blood pressure is a warning sign you shouldn't ignore... Save $20 on your next Diovan prescription"
• "Know the warning signs of high blood pressure... Find out how to save $20 on your next Diovan prescription"
• "Clicking here won't lower your blood pressure... But it could lower the cost of medication by $20... Save $20 on your next Diovan prescription"

I would be careful to note, that while Diovan warning letter is setting a new precedent it might not carry as much weight as a guideline specifically issued to regulate banner advertising. I would also have no qualms about reasonable regulation of drugs with known side effects. However, I do have a problem with regulation going far beyond its stated or intended purpose.

Why is FDA wrong to require warnings inside online banner ads?

For starters, the FDA action comes across as a blind application of rules developed for print, TV or radio, without much understanding of Internet marketing. Traditional media advertising formats typically have plenty of room to present both benefits and risks of a drug within an ad unit. There is no click-path or conversion workflow - the next step after seeing the TV or magazine ad is to ask your doctor. So in case of traditional media it is reasonable to require warnings within advertising, especially given greater creative impact and persuasive power of a TV commercial or a magazine spread.

However the purpose of an Internet ad is never to get you to buy something on the spot or to ask your doctor. The only goal of an online ad is to get you to click to learn more. What are the chances of an Internet user taking interest in ad's message and not clicking it? Internet users have been trained to ignore the ads they do not care about and click the ads they like - the circumstance entirely absent from the traditional media. Requiring warnings on a landing page is absolutely appropriate, since that is where any interested user is expected to end up. Over-regulating the banners destroys the click-through and therefore the economics of the campaign without a good reason.

The absurdity of this precedent becomes apparent as we try to expand its application. Perhaps it might be reasonable to assume that a "728x90 Leaderboard" or "336x280 Large Rectangle" has enough room to include warning information. But what about smaller ad units, say "125x125 Button" or "120x240 Vertical Banner" that barely have enough room for the marketing message? Or what if the banner or the message does not mention the drug at all, focusing on the symptoms? Does it have to warn about the drug that will not be seen till the user hits the landing page? Finally, what about text links? Is one word text link ad saying "Diovan" also supposed to include the warnings fine print???

Poorly thought through regulation is certain to have side effects

What if an advertiser would comply by including the warnings in a 2px font, both in the banner and on the landing page? That could satisfy the letter of the ruling while burying the actual risk information deep in the fine print. If FDA would not take time to think through the appropriate rules that would actually make sense in online media, its half-baked and unclear precedents set by rulings such as in Diovan case would either freeze online marketing innovation or leave enough loopholes to market against the public interest. The blame for creating such perverse incentives rests squarely on FDA. Instead of helping pharma move towards responsible online marketing they are erecting inane barriers.

At best Diovan precedent demonstrates FDA's ignorance. At worst it is an example of a regulator abusing its power or acting carelessly.