FDA Issues Long-Awaited Guidance - for Mobile Medical Apps. Janssen, Look Out!

While one arm of the FDA -- the Division of Drug Marketing, Advertising, and Communications (DDMAC), the arm responsible for regulating drug promotion -- is dragging its feet issuing guidance for social media promotion (first promised for 2010, now completely off the 2011 guidance calendar; see "FDA Drops Social Media from Its 2011 Guidance Agenda"), two other arms -- the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER); responsible for regulating medical devices -- has issued guidance for mobile medical applications (see "FDA outlines oversight of mobile medical applications" where you can download the guidance document).

The guidance focuses only on a select group of applications and goes out of its way to assure the public that the FDA "will not regulate the sale or general consumer use of smartphones or tablets."

As you know, there are probably thousands of consumer-focused health apps available for smartphones. The guidance carves most of these out of its regulatory bailiwick. According to the guidance, the following represents mobile apps that FDA does NOT consider to be mobile medical apps for purposes of the guidance:

"Mobile apps that are solely used to log, record, track, evaluate, or make decisions or suggestions related to developing or maintaining general health and wellness. Such decisions, suggestions, or recommendations are not intended for curing, treating, seeking treatment for mitigating, or diagnosing a specific disease, disorder, patient state, or any specific, identifiable health condition [my emphasis]. Examples of these apps include dietary tracking logs, appointment reminders, dietary suggestions based on a calorie counter, posture suggestions, exercise suggestions, or similar decision tools that generally relate to a healthy lifestyle and wellness."

I highlighted the wording that determines whether or not FDA might consider health apps subject to being regulated as medical devices: "not intended for curing, treating, seeking treatment for mitigating, or diagnosing a specific disease, disorder, patient state, or any specific, identifiable health condition."

The guidance defines what would make an app a mobile medical app subject to regulation as:

"When the intended use of a mobile app is for the diagnosis of disease or other conditions, or the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or any function of the body of man, the mobile app is a device."

"One example," says the FDA, "is a light emitting diode (LED) included on a mobile platform with a mobile app to make that LED operate. If the manufacturer intends the system to illuminate objects generally (i.e., without a specific device intended use), neither the mobile app nor the mobile platform would be considered medical devices. If, however, through marketing and distribution, the mobile app is promoted by the manufacturer for use as a light source to examine patients, then the mobile app would meet the definition of a device. (In this case, the intended use of the light source would be similar to a conventional device such as an ophthalmoscope.)"

Are there any pharma developed and promoted mobile apps that fit this definition and thereby SHOULD be regulated as a medical mobile app?

YES, THERE IS!

Back in March, I suggested that Janssen's "Psoriasis" app for the iPhone and iPad may be a candidate for regulation as a medical device. You can read all about that in this blog post: "FDA Promises Still More Guidance! This Time It's Mobile. Janssen's Psoriasis iPhone App May Need It" and in this Pharma Marketing News article: "Pharma SmartPhone/Tablet Apps. Is There a Regulation for That?"

One of the questions I had about Janssen's Psoriasis app concerned the accuracy of the formula used to calculate PASI ("Psoriasis Area and Severity Index"), which is a tool for the measurement of severity of psoriasis. The app is intended for physicians to use in diagnosing their patients. Suppose there was a "bug" in the program that calculated the PASI score? It seems that such software needs to be regulated as a medical device by the FDA.

In fact, I notice that there is an update available for Janssen's Psoriasis app. It was issued on 31 May 2011, about a month and a half after I blogged about the app. The note relating to the update merely states "bug fix." Could there have been a "bug" -- ie, ERROR -- in the formula used?

I updated my iPhone version of Janssen's Psoriasis app, but I do not notice any difference in the app nor the instructions that come with it. The "bug fix," therefore, could actually involve the software that calculates PASI.

Regardless of whether such pharma apps may be regulated by FDA as medical devices, I strongly believe that developers of health-related apps should explain in detail what "bugs" were fixed so that users have an idea of how the "bug" may have affected them. Shame on Janssen for not being more transparent in this regard!

[This post originally appeared in Pharma Marketing Blog. 

Make sure you are reading the source to get the latest comments.]

Markets as Conversations: Can You Have a Discussion with "Psoriasis 360" on Facebook?

Alex Butler, Digital Strategy and Social Media Manager at Janssen and candidate for the Pharmaguy Social Media Pioneer Award, just informed me by email that he and his team have launched the Psoriasis 360 Facebook page, which is part of a larger disease-awareness campaign.

Alex wrote:

"The Psoriasis 360 campaign has been developed by Janssen as part of an ongoing commitment to improving the lives of patients through the provision of useful and relevant information about psoriasis. We know that people who live with psoriasis don’t always get the help and support they need to manage their condition. Many people are not aware how severe their psoriasis is, the impact that this has on their life and how to speak to their doctor about managing the condition.

"This information forms the core of the content on the psoriasis 360 website. We would like people to join our community on Facebook and share their experiences with ourselves and others. They can also connect with us and follow the latest psoriasis and 360 community news on twitter. Shortly there will also be a YouTube channel that has been set up with the primary goal of YouTube itself in mind-letting people touched by the condition broadcast themselves and share their stories with others, helping people to live better with psoriasis.

"We believe strongly that people should be able to share their views in an open a manner as possible for a regulated industry and the commenting policy reflects this attitude."

I think this pharma social media site is the first to publish ALL comments BEFORE they are reviewed. Janssen, however, reserves the right to remove any comments "if they directly talk about medication or could be offensive to people."

It also appears that Janssen will allow links to third-party videos and other information: "Janssen are (sic) not responsible for third-party materials appearing on the Psoriasis 360, including but not limited to linked third-party videos, linked third-party sites, and third-party advertisements," says the comment policy. "Janssen does not control or endorse this third-party content and makes no representations regarding its accuracy."

Of course, this leaves the door open for Janssen and/or their agency partners to post all kinds of links to information that Janssen MAY endorse and be responsible for under other circumstances.

But let's not put the cart before the horse and start criticizing this policy before we see more "conversations" on the site.

Speaking of "conversations," I will be interviewing Doc Searls, one of the authors of the Cluetrain Manifesto, about the relevance of the Manifesto for the pharmaceutical industry in today's social media world.

According to the ClueTrain Manifesto "A powerful global conversation has begun. Through the Internet, people are discovering and inventing new ways to share relevant knowledge with blinding speed. As a direct result, markets are getting smarter—and getting smarter faster than most companies."

The first 6 theses of the Manifesto state:

1. Markets are conversations.
2. Markets consist of human beings, not demographic sectors.
3. Conversations among human beings sound human. They are conducted in a human voice.
4. Whether delivering information, opinions, perspectives, dissenting arguments or humorous asides, the human voice is typically open, natural, uncontrived.
5. People recognize each other as such from the sound of this voice.
6. The Internet is enabling conversations among human beings that were simply not possible in the era of mass media.

I'm most interested, however, in latter theses that are relevant to the growing list of pharmaceutical Facebook pages; namely "The ideal, according to the manifesto," as reported in wikipedia, "is for the networked marketplace to be connected to the networked intranet so that full communication can exist between those within the marketplace and those within the company itself (thesis 53.) Achieving this level of communication is hindered by the imposition of ‘command and control’ structures (thesis 54-58) but, ultimately, organizations will need to allow this level of communication to exist as the new marketplace will no longer respond to the mass-media ‘voice’ of the organization (theses 59-71)."

What I notice on the "Psoriasis 360" FB Wall as well as other pharma FB Walls is that often the response to comments come from unidentified, branded accounts that may or may not be real "human beings." On Psoriasis 360, the responses come from "Psoriasis 360." It's a closed loop that does not bring me to any real human being.

Therefore, I made this post today to the Psoriasis 360 FB Wall:

"Good luck on your new FB page. A piece of advice I'd like to see implemented is for the Janssen people who are responsible for this FB page AND for the ppl who are part of the psoriasis team at Janssen to perhaps identify themselves and/or post their photos to the site. I know this is sometimes a problem because of pri...vacy issues, but eventually the general public would like to know who they are talking to. Having replies come from REAL identifiable ppl may help generate discussion better than having replies come from 'Psoriasis 360.' What do you think?"

Until pharma can break down the "command and control" structure within its marketing organization and allow voices from real people within the organization to respond to consumers, it will never achieve the vision of the ClueTrain Manifesto.

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The Relevance of the Cluetrain Manifesto in a Social Media WorldWhat's Still Not "Conversational" in Today's Markets?


A conversation with Doc Searls, Senior Editor of Linux Journal and co-author of The Cluetrain Manifesto, about the relevance of the Manifesto for the pharmaceutical industry in today's social media world. Doc will preview the keynote presentation he plans to make at the upcoming Digital Pharma East conference. (See guest bio.)



Airs LIVE on: Thursday, October 7, 2010 * 2 PM Eastern USA

Go to this Pharma Marketing Talk Segment Page to listen to the LIVE show via streaming audio on the Web or to listen to the podcast archive afterward.

Will Janssen-Cilag's ADHD YouTube Video Go Viral and Win an Award?

I, and others, have often criticized pharms's forays into social media as being "inauthentic" because no real dialogue is allowed (see, for example, "Pharma "Social Networks": Close But No Cigar Award"). Without the dialogue, social media campaigns are not likely to reach full potential by "going viral," which is the point recently made by my Twitter friend @jonmrich during an #hcsmeu discussion last Friday. "Here's a hint for pharma," said Jon, "Nothing will go viral if you don't allow 'Likes' or comments. Guaranteed."

There are, however, a few pharma social media sites that DO allow comments and Johnson & Johnson (JNJ) leads the pack in that regard.

Today, I discovered (hat tip to @andrewspong) that Janssen-Cilag, Ltd, part of the Johnson & Johnson family of companies, is probably the first European pharmaceutical company to produce a non-branded disease awareness YouTube video that allows comments and "Likes." The video is entitled "ADHD: A day in the life by Janssen-Cilag Ltd." You can view the video here or see embedded version at end of this post. But just in case it is pulled in the future, here's a screen shot:

According to the channel notes "This new short film, produced by Janssen‐Cilag Ltd , tackles some of the issues surrounding Attention Deficit Hyperactivity Disorder (ADHD) from the perspective of a child with the condition. For more information visit www.livingwithadhd.co.uk.

"The film was made after talking to groups of doctors, patients, parents and teachers, who told us that too often people think 'ADHD' is just an excuse for 'badly behaved kids'. The film should help people understand what it's like to actually have ADHD.

"If you know anybody affected by ADHD, please do share this film with them. Together, let's make sure all families get the help and support they need."

The "Commenting Policy" states "All submissions will be reviewed and may not be posted if deemed inappropriate. Comments which are off-topic, offensive, or promotional, will not be posted. Please note that we will not post comments about any specific products or treatments, whether they are sold by Janssen-Cilag Ltd or not."

@garymonk, who apparently is the person responsible for this YouTube site, says that Janssen-Cilag has published the "vast majority" of comments. I believe it because there is "a couple of spats boiling away" according to @andrewspong, another Twitter friend of mine.

The site also allows visitors to vote whether or not they "Like" the video. As of today only 51 votes have be cast (43 like the video, 8 do not like it).

Will this video go viral? So far the video has been viewed 58, 624 times since it was uploaded on June 9, 2010.

It's interesting to note that the Johnson & Johnson (JNJ) YouTube video, "Brad's Story: A 12-year old with ADHD," is at the top of the list of related videos. It also allows comments and "Likes." The JNJ ADHD video was uploaded to YouTube back on June 22, 2009 and has been viewed 62,983 times (150 "Likes" vs 12 dislikes). So, by that measure, the Janssen-Cilag video is doing rather well. It should be pointed out that JNJ's YouTube Health Channel includes 302 videos. In all, the total upload views for JNJ's videos is 2,170,352.

JNJ Health Channel's Rob Halper, Director, Video Communication at Johnson & Johnson, is a "Friend" of Janssen-Cilag's Living with ADHD. "Great channel! Terrific contribution to You Tube," said Rob. BTW, Rob Halpert is one of the people nominated (by me) to receive the coveted Pharmaguy Social Media Pioneer Award (see the announcement below).

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The Pharmaguy Social Media Pioneer Awards

We might be tempted to give Janssen-Cilag a reward for launching "ADHD: A day in the life" social networking campaign. But instead of having awards for specific pharma social media sites or campaigns, why not give awards to the pioneers who have lead the way? We can learn more from how these pioneers overcame the obstacles to launch social media projects or promote social media than from the end result – even if the end result is flawed. People tend to live much longer than their creations and pharma social media pioneers are no exception. They may move on to new positions and spread their influence far and wide.

Who is @garymonk, for example? I want to know more about this person. How did he get to be in charge of the Janssen-Cilag YouTube ADHD channel? What are the issues he had to deal with? Etc.

That is what the Pharmaguy Social Media Pioneer Award is all about. Let's discover the pioneers and hear their stories. Please use this online form to nominate candidates. The introduction explains the rules for nominating candidates and you can also vote on a dozen or so candidates that I have already chosen.

P.S. I found out who @garymonk is. He is Gary Monk, a Product Manager (Marketing) at Janssen Cilag and, according to his LinkedIn profile, he has already won a few awards such as: The "2009 PM Society Digital Awards - Triple Award Winner (1) Best overall promotional solution (2) Best Integrated Campaign (3) Best Edetail." Nevertheless, I added his name to the nominees for the Pharmaguy Social Media Pioneer Award.

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