My friend Rich Meyer over at DTC Marketing Blog wrote an inflammatory-sounding post titled "Time to eliminate fair balance on DTC ads." With a title like that, this post is sure to be read by a lot of pharma marketing pundits.
But Meyer is not talking about TV or print drug ads directed at consumers. He specifically is referring to online direct-to-consumer (DTC) advertising:
"...fair balance online and in search makes no sense. Patients are not going to see an online ad or search copy without doing more research and the FDA needs to acknowledge this by revising guidelines."
Recall that in DTC advertising, fair balance refers to the presentation of accurate and fair assessment of the risks as well as the benefits of the drug (more here).
"DDMAC needs to come into the 21 century and provide guidelines that are realistic on how patients make healthcare decisions," says Meyer. "Too many online drug ads provide little in the way of benefits because there is so much fair balance. Does DDMAC and the FDA really believe that someone is going to see an ad for a prescription drug and ask their doctor about it without doing more research?"
It sounds like Meyer is urging the FDA to re-instate the "one-click rule," which the agency shot down in those famous 14 NOV letters in April, 2009. That would mean reversing itself and losing face. But wait! DDMAC no longer exists! It was reorganized as the Office of Prescription Drug Promotion (OPDP)! OPDP can reverse the old DDMAC (Division of Drug Marketing, Advertising and Communications) ruling on the one-click rule and the FDA won't lose face! Brilliant!
BTW, Meyer isn't alone in wishing the return of the one-click rule; see "Pharma Prefers '1-Click Rule' for Presenting Fair Balance in Social Media & Other Internet-based Rx Ads" and "Merck Says FDA Should Approve the 'One-Click Rule'".
Showing posts with label one-click rule. Show all posts
Showing posts with label one-click rule. Show all posts
Monday, October 15, 2012
Thursday, June 21, 2012
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?
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?
Monday, April 16, 2012
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.
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.
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