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Wednesday, April 16, 2014

Delete This and Delete That, Says Novartis to FDA Regarding Recent Social Media Guidance

The comments are in! As usual, the pharma industry waited until the last second to submit comments to FDA Docket 2013-N-1430 regarding "Guidance for Industry: Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics" (see "FDA Publishes First Piece of Long-Awaited Social Media Guidance").

See the end of this post for links to all the comments submitted. In this and following posts, I review a few of the comments made by major players (Novartis, Pfizer, PhRMA, and BIO).

I have already interviewed a few other people about the comments they submitted. Listen, for example, to this podcast: "The Clouds of Social Media Guidance" and this Pharmaguy Audio Snippet from Paul Ivans, President and CEO, Evolution Road, LLC:



In my opinion, the most "cheeky" comments come from Novartis, which advised FDA to "delete" some specific wording from  the guidance and example 3, which has to do with pharma marketers making suggestions for placement of its promotional messages on independent third-party sites. Novartis suggests that FDA delete the phrase “but does not direct the placement of the promotion within the site” and delete completely example 3.

Cheeky or not, Novartis is very elegant and precise in explaining the rationale for its suggested edits.

"A firm often may direct where product promotion or advertising should be placed on a third-party site without having control or influence over the content on that site," said Novartis. "The firm does this to provide the product information to a relevant, appropriate audience, while reducing the likelihood the product information would be viewed by an audience for whom the product would either not be appropriate, or not FDA-approved. For example, on a website that provides consumer health information on a multitude of diseases and conditions, a firm might buy advertising space for a product approved in advanced breast cancer on webpages relating to breast cancer or metastatic breast cancer. It would do so to ensure the placement of the product promotion targets the most relevant audience, i.e., a patient population for whom the product is approved.
More important than placing an ad where it's most appropriate, Novartis suggests that pharma also wants to be pro-active in ensuring that ads NOT be placed next to off-lable information:
"Alternatively, a firm might provide direction to the third-party to avoid placement of its promotion on certain areas of the site," said Novartis. "Using the example above, if the firm was aware that its product to treat advanced breast cancer had considerable off-label use in treating colorectal cancer, the firm would direct the third-party site not to place its ad on pages within the website relating to colorectal cancer."
Novartis also takes FDA "to school" to teach the agency what behavior it should encourage:
"In these instances, directing the placement of product promotion is not only appropriate, but FDA should encourage firms to place product promotion on third-party sites responsibly, on sites and locations within those sites where an appropriate audience would be most likely interested in learning about a particular product," said Novartis. "This approach is similar to what occurs with more traditional print media. Firms may place media buys in certain publications based on the target audience of the publication. For example, a firm promoting a product approved for use in treating epilepsy in adults may purchase advertising space in a neurology medical journal, as healthcare professionals within this specialty are more likely to read this publication and treat patients with epilepsy. If the firm is aware that healthcare professionals occasionally prescribe the product off-label to treat epilepsy in pediatric patients, the firm may choose specifically not to buy advertising space in a journal dedicated to pediatric medicine." [my emphasis]
Ha! If  you believe that pharma marketers deliberately do NOT advertise in specific journals because HCP subscribers to that journal may sometimes prescribe a product off-label, then I have a bridge in New York that I'd like to sell you.

In any case, avoiding ad placement next to off-label information is still a good practice that the industry should diligently follow whenever possible.
"Directing the placement of product promotion on a third-party site does not correlate to the firm having any more control or influence over the content of the site than if it did not direct where to place the promotion on that site. Firms should be required to submit the pages surrounding their product promotion in addition to their product promotion only if they had direct control or influence (e.g. authorship or editorial control) over the content appearing on the surrounding page(s), as described on lines 133-136 of the draft guidance."
I will have more comments about comments in subsequent posts. Meanwhile, here's a list of all the comments submitted to FDA and links for accessing them:

DOCUMENT ID: FDA-2013-N-1430-0004
DOCUMENT TYPE: PUBLIC SUBMISSIONS
POSTED DATE: 04/15/2014
DOCUMENT TITLE: Comment from Novartis

DOCUMENT ID: FDA-2013-N-1430-0005
DOCUMENT TYPE: PUBLIC SUBMISSIONS
POSTED DATE: 04/15/2014
DOCUMENT TITLE: Comment from Animal Health Institute

DOCUMENT ID: FDA-2013-N-1430-0006
DOCUMENT TYPE: PUBLIC SUBMISSIONS
POSTED DATE: 04/15/2014
DOCUMENT TITLE: Comment from Eli Lilly and Company

DOCUMENT ID: FDA-2013-N-1430-0007
DOCUMENT TYPE: PUBLIC SUBMISSIONS
POSTED DATE: 04/15/2014
DOCUMENT TITLE: Comment from Eli Lilly and Company

DOCUMENT ID: FDA-2013-N-1430-0008
DOCUMENT TYPE: PUBLIC SUBMISSIONS
POSTED DATE: 04/15/2014
DOCUMENT TITLE: Comment from Valeant Pharmaceuticals

DOCUMENT ID: FDA-2013-N-1430-0009
DOCUMENT TYPE: PUBLIC SUBMISSIONS
POSTED DATE: 04/15/2014
DOCUMENT TITLE: Comment from Coalition for Healthcare Communication

DOCUMENT ID: FDA-2013-N-1430-0010
DOCUMENT TYPE: PUBLIC SUBMISSIONS
POSTED DATE: 04/15/2014
DOCUMENT TITLE: Comment from Digital Health Coalition

DOCUMENT ID: FDA-2013-N-1430-0011
DOCUMENT TYPE: PUBLIC SUBMISSIONS
POSTED DATE: 04/15/2014
DOCUMENT TITLE: Comment from Pharmaceutical Research and Manufacturers of America

DOCUMENT ID: FDA-2013-N-1430-0012
DOCUMENT TYPE: PUBLIC SUBMISSIONS
POSTED DATE: 04/15/2014
DOCUMENT TITLE: Comment from Social Media Compliance Council

DOCUMENT ID: FDA-2013-N-1430-0013
DOCUMENT TYPE: PUBLIC SUBMISSIONS
POSTED DATE: 04/15/2014
DOCUMENT TITLE: Comment from Shire

DOCUMENT ID: FDA-2013-N-1430-0014
DOCUMENT TYPE: PUBLIC SUBMISSIONS
POSTED DATE: 04/15/2014
DOCUMENT TITLE: Comment from Pfizer Inc

DOCUMENT ID: FDA-2013-N-1430-0015
DOCUMENT TYPE: PUBLIC SUBMISSIONS
POSTED DATE: 04/15/2014
DOCUMENT TITLE: Comment from Biotechnology Industry Organization

DOCUMENT ID: FDA-2013-N-1430-0016
DOCUMENT TYPE: PUBLIC SUBMISSIONS
POSTED DATE: 04/15/2014
DOCUMENT TITLE: Comment from Klick Health

DOCUMENT ID: FDA-2013-N-1430-0018
DOCUMENT TYPE: PUBLIC SUBMISSIONS
POSTED DATE: 04/15/2014
DOCUMENT TITLE: Comment from Medical Information Working Group (Ropes and Gray and Sidley Austin LLP)

DOCUMENT ID: FDA-2013-N-1430-0019
DOCUMENT TYPE: PUBLIC SUBMISSIONS
POSTED DATE: 04/15/2014
DOCUMENT TITLE: Comment from Colleen Cosgrove

DOCUMENT ID: FDA-2013-N-1430-0020
DOCUMENT TYPE: PUBLIC SUBMISSIONS
POSTED DATE: 04/15/2014
DOCUMENT TITLE: Comment from Patient Health Perspectives LLC

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