15 Oct The FDA finally gets interactive
The FDA recently released its draft of “Guidance for Industry Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics.”
This document arrived in response to years of questions, concerns, and pleading for clear guidance from pharma companies, medical device companies, and the healthcare marketing agencies they engage.
The good news: The FDA got the message. And overall, they seem to “get it” – the guidelines are logical and conducive to balanced healthcare marketing communications in interactive media.
There are 3 key guidelines to follow in deciding whether you are responsible for interactive content:
1. You are responsible for the content of any site that you own, control, create, influence, or operate. You are responsible even if your influence is limited in scope. For example, if you have even just partial editorial, preview, or review privileges over the content provided, you are responsible for that content.
2. You are responsible for any content you place on a third-party site. However, if you provide only financial support (such as through an unrestricted educational grant) and have no other control or influence on that site, you are not responsible for any additional information on a third-party site and have no obligation to submit that content to the FDA. If you provide promotional materials to a third-party site but do not direct the placement of the promotion within the site and have no other control or influence on that site, you are responsible only for the content you place there.
3. You are responsible for the content generated by an employee or agent who is acting on your behalf to promote your product.
How to submit interactive promotions for FDA review
The draft guidelines provide 5 directives for submission of interactive promotions:
1. At the time of initial display, you must submit in their entirety all sites for which you are responsible. Use Form FDA 2253 or Form FDA 2301. You must submit the comprehensive static product website with the addition of any interactive or real-time components.
2. For third-party sites on which your participation is limited to interactive or real-time communications, you must submit the home page of the third-party site, along with the interactive page within the third-party site and the your first communication, on Form FDA 2253 or Form FDA 2301, at the time of initial display.
3. Once every month, you must submit an updated listing of all non-restricted sites for which you are responsible or in remain an active participant. It is not necessary to submit screenshots or other visual representations of the actual interactive or real-time communications with the monthly updates.
4. If a site has restricted access and the FDA does not have access, you must submit all content related to the discussion, which may or may not include independent user-generated content, to adequately provide context to facilitate the review. You must submit screenshots or other visual representations of the actual site, including the interactive or real-time communications, monthly on Form FDA 2253 or Form FDA 2301.
5. When submitting the site, the FDA recommends that you take formatting factors (including the actual layout that site visitors see) into consideration to enable the FDA to view the communications as a whole.
Questions remain – for example, regarding how much labeling to include and how it can be integrated into certain formats of interactive media. But the draft guidelines are a good, if overdue, start.
Clearly, they will require careful consideration by marketers when planning and creating promotional initiatives. The guidelines will require careful submission of promotions for initial FDA review. And the guidelines will require an ongoing effort: training of personnel, continuous monitoring of sites, and monthly reporting.
An adept, experienced healthcare marketing agency such as Bryant Brown Healthcare can help you comply with these guidelines.