FDA Goes After Pharma Facebook Likes

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Last month, the FDA tagged a dietary supplement maker for a laundry list of infractions, but one item tucked away in a December 11 warning letter stands out. The agency complained to Amarc Enterprises that one of its products was ‘liked’ last year on its Facebook page. This was cited as one example of numerous testimonials that could be construed as claims that cause the Poly MVA supplement to be considered a drug.

Specifically, the March 10, 2011 ‘like’ said this: “PolyMVA has done wonders for me. I take it intravenously 2x a week and it has helped me tremendously. It enabled me to keep cancer at bay without the use of chemo and radiation… Thank you AMARC,” according to the FDA letter. The effusive endorsement, however, is no longer visible and the entire Facebook page is about to be taken down.

The issue, however, is that the FDA referred to a Facebook ‘like’ as a testimonial, because this may have real implications for the pharmaceutical industry. As Alec Gaffney of Regulatory Focus wrote, the “FDA’s interpretation that a ‘like’ implies endorsement could be a precedent-setting action by an agency that has been slow to issue a formal social media policy.”

Indeed, this is the sort of move that will only make it more difficult for drugmakers to navigate social media – or not. The long-standing absence of a formal agency policy toward social media has only left marketers and product managers anxious about the extent to which various social media tools should be used. In fact, it still remains unclear if and when the FDA will issue a policy (read more here).

One possible reason is the FDA “worries that writing down its policies on paper could invite legal challenges to its authority over the underlying commercial speech, which courts have often recognized is protected under the First Amendment,” former FDA commissioner Scott Gottlieb writes in Forbes. He suggests the handwringing has a long history when it comes to stating hard-and-fast rules about promotional activities.

Such concerns can only be underscored by a recent federal appeals court ruling that overturned the conviction of a former sales rep for allegedly encouraging doctors to prescribe a drug on an off-label basis. Technically, the decision only apples to three states, but the FDA is being closely watched for its strategic reaction to dealing with such promotional activities (read more here and here).

Meanwhile, drugmakers must grapple with appears to be a piecemeal sort of policy, one that may eventually take shape over time thanks to clues found in warning letters. This is of little help today, however, to marketers who are now left to wonder the extent to which they are going to be held responsible for each and every bit of content on a web site – or a Tweet for that matter – regardless of its origins.

Last year, you may recall, Johnson & Johnson (JNJ) closed its year-old Psoriasis 360 page on Facebook because a growing number of comments that had to be removed because specific drugs were mentioned or, in some cases, offensive language was used. The Facebook page was the first in the pharmaceutical industry to allow comments to appear before being vetted by a drugmaker, although a loyal reader notes the page was in the UK and, therefore, not subject to FDA scrutiny (back story).

For the FDA, though, this approach, rather than issuing a formal guidance, may make some sense if a protracted and complicated deliberation with stakeholders – or untold legal challenges – can be avoided. What do you think?

– See more at: http://www.pharmalot.com/2013/02/whats-not-to-like-facebook-and-the-fda/#sthash.BalzSldb.dpuf