Add another electronic advertising vehicle to DDMAC’s growing list of potentially problematic DTC media that it must regulate: mobile device promotion.

While it is not a new idea for drug advertising to reach smartphones like BlackBerries or iPhones, questions have been raised about whether consumers can receive a balanced message if they download content, but do not have the proper software or connectivity to view some of the information linked to it.

Some smartphone drug ads now include links to warning and label information. But if a consumer downloads an ad to his or her phone, but does not have the proper software or loses the signal and later cannot view the label and risk information, is it misleading?

It’s another conundrum the Division of Drug Marketing, Advertising and Communications will have to address as it attempts to write guidance on the use of Internet and social media advertising.

DDMAC Director Thomas Abrams, when asked about the issue Sept. 21 during the Food and Drug Law Institute’s Advertising and Promotion Conference, could only say the issue is being looked at by an FDA social media working group.

Lisa Stockbridge, acting branch chief of the CBER Advertising and Promotional Labeling Branch, said her office has received those types of applications, but does not have clear directions on how to deal with them yet.

Stockbridge seemed to imply that as long as all the necessary elements were included in the ad, it would be sufficient for now.

“They usually come with a hotlink or an open attachment and I don’t know about yours, but [my smartphone] opens attachments,” she said. “That’s what we’re looking at on [Form] 2253.”

[Editor's note: The Pink Sheet is sponsoring a webinar on how to navigate changing trends in promotion and advertising. The Oct. 21 event will feature former FDA Associate Chief Counsel Arnold Friede, who will discuss the agency's current and upcoming enforcement priorities. To register, call 800-332-2181, email custcare@elsevier.com, or visit http://pages.elsevierbi.net/AC090710LP .]

One issue with the ads is the efficacy claims are downloaded as part of the ad, but since an entire label cannot fit in a cell phone message, it must be linked. It is access to the information behind the links that is the problem with smartphone advertising.

Abrams said in general the principles for drug advertising still would apply and presentation would be the deciding factor.

“If you’re presenting efficacy information, you should present risk information the same way,” he said. “It’s going to be a strange format. As far as the PI, that’s a very interesting question. You can link to it, but connectivity is another issue.”

“One-Click” Strikes Again

Advertisements with links also bring back conversations about the so-called “one-click rule.” Many in industry believe such a rule – which would allow ads that require consumers to click a link in order to get risk information – should be FDA's regulatory standard.

Probably the most famous case of FDA's standards for the Internet emerged last year when the agency sent notice of violation letters to 14 firms over sponsored links appearing in Google search results. The agency said the ads were inappropriate because they included efficacy claims, but not risk information. The fact that the sponsored links led to websites where risk and product labeling was found did not matter (Also see "Internet Promotions Must Be Redesigned After FDA Cites Sponsored Web Links" - Pink Sheet, 13 April, 2009.).

Smartphone ads, as well as those that could appear via text message, Twitter or Facebook, all could pose a challenge for regulators in determining how much risk information has to appear in the original message and how much can be a click away. So far, all that FDA's spate of letters on sponsored search returns has made clear is that the agency considers zero risk information too little.

Texts and Twitter posts especially, like TV ads, present limited space requirements that would not allow for brief summary information to appear, let alone many efficacy claims, without a link for more information.

Abrams, upon being asked about the rule, reminded those at the conference that it does not exist.

“There’s no one-click rule,” he said. “What we require is when you make a claim or representation about a drug you should have fair balance with the claim as per our long-standing policy and that is not altered.”

More Internet-Related Issues Unresolved

Abrams said a social media working group is attempting to deal with the smartphone issue, as well as other Internet and social media guidelines. The 20-person group includes management, reviewers, regulatory counsel, a social scientist and other DDMAC personnel, as well as representatives of APLB, and the centers for devices and radiological health and veterinary medicine.

Some of the working group members also are helping develop FDA guidance on social media. A series of guidances addressing pertinent issues is expected soon, the agency said (Also see "FDA's Internet Promotion Guidance: One Down By Year-End; Four More To Go?" - Pink Sheet, 18 October, 2010.).

By Derrick Gingery

DTC Smartphone Ads Present An “Interesting” Problem For DDMAC

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