Branded Tweets Lacking ISI: What's FDA's Thinking on This?

Branded Tweets Lacking ISI: What's FDA's Thinking on This?

This week, I attended CBI's 3rd Annual Forum on Social Media Regulations and Compliance in Alexandria, VA. Many of the medical/legal/regulatory (MLR) presenters and attendees were from smaller pharma and biotech companies such as Biogen, MedImmune, Astellas, Amarin, Ferring, etc.

In the absence of specific social media guidance from the FDA, several presenters tried to "navigate through current guidance and enforcement" to offer advice on how to develop a compliant social media strategy. This technique is what is often referred to as learning from "received precedent," which is a risky methodology considering FDA's past actions that have contradicted previously-accepted precedents (see, for example, "Death of the One-Click 'Rule' or 'Received Precedent' or Whatever!" and "FDA's Actions Speak Louder than Its Words").

One topic that was discussed by at least a couple of presenters was who controls the content on social media and, specifically, what content is pharma responsible for when it engages in social media conversations.

Glenn Byrd, Senior Director, Regulatory Affairs, at MedImmune, spoke about pharma accountability in his presentation. "At what point do we lose control of our content? When do we lose the responsibility [for content] so FDA does not come after us?" He cited "retweeting" as an example. As an non-social media example, Byrd talked about B-roll video, which pharma companies often provide to TV news stations when they are doing a story about a newly released product. "They [the news outlet] take it and they do whatever they want with it," said Byrd.

Of course, the B-roll itself must be compliant with FDA regulations. If it mentions a drug name and its indication, for example, it must also provide the important safety information (ISI) just as if it were a direct-to-consumer (DTC) ad.

But pharma companies are using Twitter to tweet about brands and their indications WITHOUT including any ISI. Take for example this LYRICA tweet that @pfizer_news sent just this morning:

This links to the press release, which has all the necessary ISI. It's as if Pfizer still believes in the "one-click rule" when it comes to tweets linking to press releases. The logic is this: there is no "received precedent" of FDA citing such tweets as violative, therefore it is perfectly OK for us [Pfizer] to do this.

Note that the tweet has been "retweeted" at least 8 times and cited a "favorite" tweet at least 3 times. The tweet has also been posted to the Pharma Marketing "News From the Pharma Industry" Forum (see here) where anyone can post a "reply" message. Thus, an ongoing conversation out of Pfizer's control can result from this tweet on Twitter and on discussion boards. That is the viral nature of social media.

While Pfizer cannot be held responsible for the retweets of its branded tweet or the conversations it may start elsewhere on the Internet, it should be held responsible for the original tweet, which is similar to the search ads FDA cited as violative in 2009 (ie, lacking important safety information).

What do you think?

Beware of Subtle Changes to Social Media Sites that Can Impact Your Brand; e.g., Novo's Levemir

Beware of Subtle Changes to Social Media Sites that Can Impact Your Brand; e.g., Novo's Levemir

Keeping up with all the changes implemented by social media sites such as Facebook and Twitter can be a challenge for anyone. But it is especially important for pharmaceutical marketers to understand how such changes can impact their use of these sites and potentially get them into trouble with the FDA. An example of this was Facebook's new policy about comments and the implementation of Timelines. I have covered those issues by interviewing experts (listen, for example, to these podcast: "Facebook Timelines for Brands: The Implications for Pharma Companies" and "Pharma Facebook Commenting Changes: The Final Story").

Some changes, however, are virtually unannounced and may go unnoticed by brand teams. Twitter, for example, has made some changes to how things are displayed on its website when people are viewing accounts like Novo Nordisk's @racewithinsulin Twitter account. This is a fully "branded" account that features a celebrity endorsement of Levemir, Novo's long acting insulin used to treat diabetes. It's tag line is: "Racecar driver Charlie Kimball partners with Novo Nordisk to prove his high performance career is possible with insulin."

The "Race with Insulin" branded Twitter account is old news (listen to this podcast "Novo Nordisk's Race With Insulin Campaign: It's Not Just About Twitter"). What is new, however, is how information is laid out on the screen. Here's a screen shot (click on the image if you need a better view):

What I noticed is that the box that provides the "fair balance"/safety information is partially hidden by Charlie's tweet stream. I commented previously how this information is virtually impossible to read even when it is fully visible (read "Can You Read This Fair Balance on Race With Insulin Twitter Page, or Is It Just Me Having Problems?"). Now, however, it is even impossible for people with perfect eyesight to read fully.

No matter how wide I pull the screen, the safety information is blocked by the tweet stream. I also cannot scroll down to bring the bottom part of the safety information into view because that info is a static image in the background and only the tweet stream middle section of the screen scrolls up and down.

Novo Nordisk has changed the background image since the last time I visited the @racewithinsulin site. Part of that change was to move the safety information further down, which has lead to the second problem I noted above.

The first problem, however, is likely due to the new design implemented by Twitter. Novo Nordisk has not updated the background image to be compatible with this new design.

It's possible that the FDA may look at this branded site and determine that it violates regulations because the display of major safety information is not fully part of the branded message, which clearly is that Levemir is used for the treatment of diabetes and that you can live a "high performance career" with Novo's brand of insulin.

Of course, the FDA would have to read this blog post to learn about this.

Yahoo!'s Claim That Patients Are "Ambivalent" When It Comes to Side Effect Information in Search Ads Is BS!

Yahoo!'s Claim That Patients Are "Ambivalent" When It Comes to Side Effect Information in Search Ads Is BS!

Yahoo! submitted comments to Docket No. FDA‐2009‐N‐0441 regarding Promotion of FDA‐Regulated Medical Products Using the Internet and Social Media Tools (find it here).

In defense of the "one-click rule" for space-limited "generic" search ads and "Rich Ads in Search (RAIS)," Yahoo! presented a study that purports to prove that "When it comes to side effects... the patient mindset appears to be ambivalent until research for an ailment is needed" (see Exhibit A (pdf)). The following chart was offered in evidence:

The question, which was posed to 2,540 Online Americans in the study, was "As you may or may not know the FDA (Federal Drug Administration) mandates companies to lay out side effect information or risk factors in advertising. Using the scale below please tell us how much you agree with the following statements when it comes to medication advertising online."

It's not clear from Yahoo!'s comments whether or not respondents to their survey were asked to look at specific online ads. Recall that Merck, in its defense of the "one-click rule," did a study that asked respondents opinions about specific ads they were shown (see "Merck Says FDA Should Approve the 'One-Click Rule'").

A bigger problem I have with these data is that they do not support Yahoo!'s conclusion. Although 23-26% of respondents claim they agreed or strongly agreed with the statements, twice as many (43-45%) must have said they disagreed or strongly disagreed! I contend, therefore, that these results DO NOT prove the point that Yahoo! was trying to make. In fact, the data prove just the opposite: patients DO pay attention to medication side effects in online advertising BEFORE they ask their doctors or research it more online!

Am I not seeing something that I should be seeing in these data? Take a look at Exhibit A (pdf) yourself and tell me what you think.