Google just showed off mockups of its fancy new pharma ads at FDA’s social media hearing, on November 12. A few months back, the big G mentioned that it was working on ads to appease both pharmaceutical marketers and FDA, but this is the first time most people got to lay eyes on the new ad units.

According to Mary Ann Belliveau, Google’s director of healthcare advertising, the new ads will include both brand name and healthcare information, as well as a brand URL. To make the ads FDA compliant, each unit will include an abridged warning notice that links to the full risk information. The lead subject line will link to the brand site, so each ad will have two different URLs linking to two different locations.

As it stands right now, pharma companies cannot use brand names and brand URLs in link ads without risk information. This is pretty much impossible to achieve since the risk info takes up too much room on the tiny ads. The other option is to only include the disease state and a generic URL, but Belliveau made it clear in her presentation that this isn’t a practical option.

In April, FDA sent out 14 warning letters to pharma companies that were mixing brand and health information without risk information in the actual search ad. Many of the pharma companies assumed that as long as risk/benefit information was within one click away, then they were in the clear. They assumed wrong, and many were forced to pull their search ads.

Earlier in the day, Yahoo said that it was testing new rich links in text ads to try to appease FDA requirements. The new ads would allow risk or company information to appear when a user hovers over a logo.

FDA is taking in all the suggestions from the Big Two search firms during the two-day hearing, but made it clear that this is just an information gathering process and that a formal decision on guidelines or actions would be down the road.

Image Courtesy of Google

A Sanofi Aventis employee complained about the 14 warning letters and asked why the practice of purchasing sponsored links on search engines, without fair balance information, was allowed to go on for so long if it was wrong and what else should companies be looking at that they might not know is wrong.

“If you do not know, of if you are not sure [if an ad is okay], submit a proposal for advisory comments,” said Kristin Davis, deputy director, DDMAC. “We have limited resources – the fact that you didn’t hear from us, just like the fact that you went 15 miles over the speed limit on your way to work – doesn’t mean that it’s okay. It just means that the cops weren’t on the road that day. Unless you have advisory comments indicating our opinion, you are not insulated from enforcement action. Especially if you are exploring some new tool and you are not exactly sure, I really encourage that you submit for advisory comments. We prefer that to sending out enforcement letters.”

Davis made it clear that the sponsored link letters were for ads where the pharma company has control of the content, so that the organic search results from Google’s search algorithms are not what FDA is looking at. FDA is targeting sponsored ads on sites like Google and Yahoo where the company has purchased a link space and created a message to be submitted on a Form 2253.

Another audience member commented that the link ads are more like the front cover of a brochure, in that the pharma company’s intent is not necessarily for that sponsored link to be the end, but to be the beginning.

“If you go to a physician’s office and you see the different brochures, you look and see which one you want to take,” she told the panel. “I looked at a lot of those sponsored links that got a letter, and when you click on them, it’s like turning a page.”

What she was referring to was the “one-click rule” that many companies felt was an unwritten rule allowing them to have risk/benefit information within one click of the sponsored link ad.

“It is the Internet, so you can’t turn a page, but you can click through,” a third person argued. “I’m just trying to figure out the guidance now, because it was 14 letters – Where do we go from here.”

Davis replied that only a fraction of the audience ever clicks through to the link page and never sees the risk/benefit information, therefore they should be considered standalone ads.

“Because you are on the Internet, you can’t forget all the regulatory requirements that apply, whether it’s labeling or advertising on a pen,” Davis said. “You’re not going to be putting your indication and think you are somehow exempt from the requirements to disclose risk information. If you can fit in some benefit statement, you can incorporate risks. If you can’t because you are limited by the amount of characters you can include, don’t only convey the positive without the negative.”

She restated that FDA’s regulations are clear on what pharma can and cannot do in terms of failing to disclose some of the required information.

The panel said that FDA is considering social media guidelines and that the topic is a priority.

In related news, the DDMAC user-fee program will not be coming back any time soon. It was not covered because it never went into effect. The voluntary program to get TV ads reviewed within 45 days lost its authority and won’t be revitalizing the program any time soon, one panel member said. Instead, Congress appropriated fundings for DTC advertising activities and created an additional review group within DDMAC.