April 9, 2014 — The Coalition for Healthcare Communication issued the following press release today regarding the CHC Social Media Comment it submitted yesterday on the FDA draft guidance issued in January.
FOR IMMEDIATE RELEASE:
Coalition for Healthcare Communication
CHC Comment on Social Media Draft Guidance Calls for Greater Clarity, Reasonableness
New York, NY, April 9, 2014 – The Coalition for Healthcare Communications’ comment to the FDA regarding the agency’s recent draft guidance on interactive promotional media asks the agency to clarify some of its language and points out several unintended consequences the draft guidance might create, such as a chilling effect on interaction with the media and an overwhelming number of submissions to the FDA that are neither meaningful nor appropriate.
“We applaud the FDA’s efforts in developing this social media draft guidance and appreciate that the agency has stated in the document that drug companies are not responsible for independent media and content that are not under their control,” said Coalition for Healthcare Communication Executive Director John Kamp. “However, there are multiple issues the agency may not have been aware of when it drafted the guidance, including the important question of how influence or control is defined in the context of ad placement, and these still need to be resolved,” he said.
Specifically, the CHC comment points out that the agency “appears to be defining control to include company influence over the placement of advertising – a common practice in all advertising, including print, broadcast and online advertising.” CHC asserts that exercising control over ad placement in no way influences the surrounding content.
The CHC contends in the comment that the FDA has sufficient authority outside of this draft guidance to investigate sponsor placements “without invoking a ‘placement constitutes control’-based guidance,” and notes that “If the provision stands, it could not only affect online/social media advertising practices, but also migrate into the buying of all media, an unfortunate result for FDA and generally accepted media practice and journalism ethics.” This position also could result in a significant number of Form 2253 submissions that would inhibit – not facilitate – good FDA marketing review practice, according to the comment.
In the comment the CHC also calls into question a provision in the guidance which states that firms are responsible for promotion on third-party sites if they collaborate or have editorial, preview, or review privileges. Because a broad interpretation of this provision could mean that firms cannot hold public relations workshops for any media that it supports with advertising or unrestricted grants and could even preclude companies from working with or speaking to media staff, the CHC is seeking additional clarification on this matter.
“The FDA perhaps did not envision some of the real-world implications of its draft guidance,” Kamp explained, such as requesting that surrounding pages be submitted with promotional materials for FDA context in evaluating a third-party site. “Our members’ media teams assert that this request is virtually impossible to comply with, because the advertising folks do not have access to the final content when making a placement,” Kamp said. “This becomes even more complicated when you look at paid searches, where placement is suggested by keywords and the results are organic.”
The CHC comment, which also requests clarification on restricted versus nonrestricted sites, logistical issues and submission requirements, was submitted to the agency on April 8.
The Coalition for Healthcare Communication is an organization that promotes the free exchange of scientific and medical information.
For more information, contact John Kamp at 703-801-4582 (mobile).
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