PharmExec Blog

Live from DIA: FDA Warning Letters Stir More Questions Than Answers

A panel of regulators from FDA’s Division of Drug Marketing, Advertising, and Communications were taken to task, this morning at the Drug Information Association’s annual meeting, for 14 warning letters levied on drug companies for not including risk information in online search ads.

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.

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One Comment

  1. Posted June 25, 2009 at 10:48 pm | Permalink

    Deputy Director Kristin Davis was right on the mark in her responses including her analogies. Who are we kidding here? It is wholly irresponsible of a regulated industry to attempt to swindle the public with its products. It is inexcusable to even claim ignorance and more unsettling that any attempt would be made to justify starting or continuing the practice of not informing the public with full product disclosure.

    Hats off to Kristin Davis in her handling of the audience members; the logic was irrefutable.

One Trackback

  1. [...] Abram’s comments, made during a panel this morning at the Drug Information Association’s annual meeting in Chicago, prompted audience members to probe Abrams, and his CBER colleague Lisa Stockbridge, branch chief of the Advertising and Promotional Labeling Branch, about specific policies governing online promotion. One audience member wondered whether unbranded, educational campaigns online could link to branded sites, or if that kind of activity would generate an enforcement letter. Abrams responded that his own question, in that instance, would be, “Why are you linking to a brand site?” if a campaign is ostensibly designed to educate about a disease. When pressed, he said an educational or awareness campaign – which isn’t required to present risk information, since no drug is being promoted – linking to a brand site would “have to be considered on a case by case basis.” Industry has been browbeating DDMAC for social media guidelines for years. [...]

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