DDMAC: It's not the medium, it's the message

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Jean-Ah Kang, a special assistant to DDMAC director Thomas Abrams, offered clues about the agency's thinking on social media, but wouldn't divulge internal plans regarding guidelines for the space.

“At this time we can't actually state our internal plans or our process for further defining the environment,” Kang told Eye on FDA blogger Mark Senak in a podcast

“We do recognize the importance of social media, like Web 2.0. We recognize that it is a reality and that it's here to stay,” said Kang.

When evaluating a specific promotion, Kang said DDMAC first takes two things into consideration:

  • Did the company or anyone working on behalf of the company (including an ad agency or consumer) create the promotional communication?
  • Is the company or anyone acting on behalf of the company actually controlling any part of the activity, including prompting others to communicate about the drug?

Kang provided the analogy of audio or video news releases, which companies use to communicate information about a new drug, for example. In that case, a media outlet could potentially alter the content of promotional materials and render them violative. In such a case, a company's defense lies in the submission of a final draft and script of the promotional materials to FDA at the time of initial dissemination—a practice required by law. “This is your proof for what you've created, and what you plan to use in the public domain,” said Kang.

“We understand that there may be a scenario where [promotional materials] may get altered, and unfortunately perhaps only the efficacy information is relayed and not the risks. You want to be comfortable that what you're proposing…is following the advertising and promotional labeling regulations,” said Kang.

Companies are always welcome to come in for advisory comments on their draft promotional materials, said Kang, noting that the easier you make it for DDMAC reviewers—the more user-friendly—the more efficiently the review will go.

However, marketers can't have it both ways, said Kang. “You can't be using something but at the same time be waiting to get advice from DDMAC on that particular proposal, such as the same claim or a similar presentation.”

In terms of the presentation of fair balance, Kang offers a test for pharma companies: “Your marketing team comes to you with a draft proposal. Imagine switching the presentation of risk information with that of the efficacy information, and ask yourself: ‘How is the fair balance with the piece at this point?' In summary, it's not the medium, it's the message.”

Kang started her role as special assistant in January 2009, and her responsibilities in DDMAC include communications, guidance and policy development initiatives, according to Karen Mahoney, an FDA spokesperson.

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