Patience Hurlburt-LawtonWhen social media was just getting started a little over a decade ago, it seemed prudent for the FDA to withhold any real decision making on marketing and communication guidelines across those channels until more time had passed. Along the way, we’ve watched social media expand, multiply and transmute in such a way that leaves little doubt it will perpetually be in a state of flux.
But one aspect that’s remained a constant since almost the beginning is social media’s undeniable staying power. As soon as that became apparent, the FDA would have been wise to begin drafting some sort of protocol and updating it accordingly.
Instead, for many years they occasionally iterated their intentions to provide guidance, while still enforcing violations against both postmarketing submission and risk disclosure requirements on social media platforms as if those platforms were any other type of medium.
The problem: social media is unlike any other type of marketing or communication channel to come before it, with interactions taking place in real time, consumers asking for guidance (and expecting feedback) in a public space and third-party users contributing their own sets of data without worrying about validity or permission.
So in 2012, Congress enacted a provision designed to force the FDA into finally establishing its internet/social media promotion policies by July 9, 2014. The FDA responded slowly, and with some points to be desired, when on January 13, 2014 they released a guidance document that would provide some insight into their views on medical device marketing on social media.
Although it was nowhere near comprehensive, it was much better than what little had come before. And so far, it’s all we have.
What We Know Now . . .
One of the biggest problems facing medical device marketers was the FDA’s postmarketing submission requirements, which state that firms must submit copies of all labeling, advertising, mailers or any other promotional materials at the time of publication or initial distribution.
But adherence to this rule was almost impossible when applied to a real-time communications format, which the FDA acknowledged in its new draft guidance. Not only did they announce their intention to use discretion when enforcing postmarketing regulations, but they also released a list of principles which companies can use as a guide when submitting promotional items.
*1. A firm is responsible for product promotional communications on sites that are owned, controlled, created, influenced, or operated by, or on behalf of, the firm. If a firm has any amount of influence over a website, even if it’s only as nominal as editorial or review privileges, the firm is responsible for anything concerning their product that appears on that site. This even extends to comments posted by users.
- Under certain circumstances, a firm is responsible for promotion on third-party sites. As with #1, if a firm has even the smallest controlling interest in a site, even if they aren’t the owners or administrators, they are responsible for all product-related content. However, if the firm is merely providing promotional materials to the site, without having any influence over their placement or any other aspect of the site, they’re only responsible for the content they contribute.
Interesting side note: If a firm only provides financial support for a third-party site, but has no control or influence of any sort, the firm is not responsible for any of its content.
- A firm is responsible for the content generated by an employee or agent who is acting on behalf of the firm to promote the firm’s product. If anyone employed by a firm in any capacity, whether as a sales representative, blogger, customer care agent, etc., posts any product-related content on any site, whether it’s owned by the firm or a third-party, the firm is responsible for that content.
However, the firm is not responsible for product-related content that is posted on third party sites if the poster has no affiliation with the firm and was in no way prompted by the firm to post the content.
In the same draft guidance, the FDA listed the criteria governing postmarketing submissions for both restricted and unrestricted sites:
- In the case of unrestricted (public) sites for which a firm is in any way responsible, they’re required to submit the entire site upon its initial launch, including static visual and descriptions of all interactive, real-time aspects. After that, an updated listing of all the firms unrestricted sites should be submitted every month (no visuals needed).
- In the case of a firm’s interactive or real-time involvement with an unrestricted third-party site over which they otherwise exercise no control, the firm is required to submit the home page, interactive pages and the first communication ever made by the firm (including visuals). After that, the firm must submit an updated monthly list of all such sites (no visuals needed), but should remember to notify the FDA immediately should they discontinue their activity on the site.
- In the case of restricted sites, or sites that are password protected and/or are not open to the public, the firm is required to make the same initial submissions as in the first two examples, after which they need only submit visuals of any product-related content, even if that content is user generated. This needs to be done on a continual basis, since monthly updates are not permitted for restricted sites.
Since 2014, the FDA has promised there will be more to come, but when that’s going to happen remains a mystery. Although many in the medical device industry were grateful for the draft guidance, just as many felt that it left countless unanswered questions and was too broad in scope. And with every passing year, the considerations keep piling up.
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