FDA Draft guidelines: Real world examples

screenshot_1393By now M-L-R teams are reading the draft guidelines from the FDA for Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics.  The most debated content of this document is going to be ” 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 .

There are a lot of third party sites that look to pharma companies for financial support in the form of paid ads or sponsorships. To the extent that these third party sites are influenced by pharma companies is going to be up for debate.  It has been my experience, for example, that some sites will change content or feature content to support the advertisers.  Is this considered influential and to what extent?  That for sure is going to lead to a lot of M-L-R meetings.


The FDA draft document further states “for example, if the firm  collaborates on or has editorial, preview, or review privilege over the content provided, then it is responsible for that content.”.  So you can run an ad on a third party site but if that site sends the screenshot to you and there is a story on your product that is not favorable and you ask to have it removed then that could be considered influential. especially when the FDA says “Under certain circumstances, a firm is responsible for promotion on third-party sites. ”

What does this mean for DTC marketers ?

(1) Advise agencies placing ads on 3rd party sites that the contact should be limited to placement of ads/content and that approval should be around the placement only, not the context/placement.

(2) Pharma companies can be held responsible if they advertise or sponsor the content on 3rd party sites and the site makes exaggerated product claims.

(3) You can solicit and publish patient testimonials, but these testimonials must be “scrubbed” by your M-L-R team.

(4) If an employee uses social media to talk about your product that employee could be considered an agent of your company and thus subject to enforcement of FDA guidelines.

There is nothing here that is different from current online marketing guidelines, but the FDA obviously is moving at a snails pace while Internet marketing is moving rapidly.

Those biopharma companies which are conservative.will continue to be conservative.   Those that are willing to accept some risk probably will be more successful with their online marketing.