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Pharma Marketing

Cannes Lions Health 2014: is pharma advertising so bad?

Cannes Lions Health 2014 festival was supposed to be the world’s first contest of creativity in healthcare and pharma advertising. Made by advertising agencies and for advertising agencies, Lions Health could not find a grand prix winner in Cannes this year. Does it prove lack of creativity, or rather that the whole concept of advertising in the healthcare industry is wrong?
No grand prix of Cannes Lions Health 2014 was awarded. A Jury made only from the advertising agencies, focus on vague “creativity” and not measurable effects or validity of choice. From K-message perspective it is all failed, with the only exception of a Grand Prix for Good award given to Colombian League Against Cancer for its Cancer Tweets campaign.
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Cancer Tweets

https://www.youtube.com/watch?v=pXWgL4NrJqg

Brand: LEAGUE AGAINST CANCER – BOGOTA
Agency: LEO BURNETT COLOMBIANA, COLOMBIA
Target: Disease Awareness Social Media Campaign
Credits:

Name Company Position
Fernando Hernandez Leo Burnett Colombiana General Creative Director
Mauricio Sarmiento Leo Burnett Colombiana General Creative Director
Carlos Oviedo Leo Burnett Colombiana Creative Director
Alexis Ospina Leo Burnett Colombiana Creative Director
Rafael Reina Leo Burnett Colombiana Creative Director
Andres Salamanca Leo Burnett Colombiana Copywriter
Alexis Ospina Leo Burnett Colombiana Copywriter
Andres Lopez Leo Burnett Colombiana Art Director
Rafael Reina Leo Burnett Colombiana Art Director
Julian Velez Leo Burnett Colombiana Art Director
Alejandra Melo Leo Burnett Colombiana Community Manager
Camilo Mendivelso Leo Burnett Colombiana Community Manager
Camilo Torres Leo Burnett Colombiana Community Manager
Cesar Peralta Leo Burnett Colombiana Community Manager
Carlos Leguizamon Leo Burnett Colombiana Community Manager
Carlos Oviedo Leo Burnett Colombiana Community Manager
Andres Salamanca Leo Burnett Colombiana Community Manager
Maicol Vera Leo Burnett Colombiana Web Designer
Natalia Valencia Leo Burnett Colombiana Account Director

Campaign Description:

A cancer that follows you virtually. Cancer is a silent disease, every year millions of people die for ignoring their symptoms. That’s why we created Cancertweets, an act that make people feel what it is like to have cancer and how easy is to ignore it. We created 7 Twitter accounts that represented 7 types of cancer and ‘spread out’ the virtual cancer throughout thousands of accounts. Virtual cancer acted as a real cancer: at first, followed silently. Then, started to manifest subtle; finally expressed its symptoms directly. Those who detected on time, virtual cancer stopped following them. Those who ignored it, received a final message.

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Unfortunately other campaigns did not bring anything innovative, striking or at least, very efficient in terms of communication, as you can see for yourself clicking at the entries list. At K-message we were not even disappointed, as this whole concept seems bit weird to us. Take a look at the President of the Jury explaining why no GrandPrix was awarded:

From our perspective it is not about “setting the bar” too high. Pharma marketing is just different. We talk about serious issues, we should base our communication on scientifically proven statements. The idea of “promoting” a pharmaceutical product to patients is from the very beginning dangerous and thus forbidden in most of the world. For the healthcare professionals, we should bear in mind that any additional noise may adversely impact their decisions and, in effect, patients well-being. Human brain while making decision can process 5 to 6 factors. In medicine there are usually hundreds of factors to be taken into account. Do we really need to produce more of it? Or shall we rather focus on making the process easier to congest, by making tools for better processing the scientific information about our products and diseases to be treated? .
Saying that, feel free to take a look at the Cannes Lions Health 2014  Gold Lions awarded campaigns. While they are not worth a Grand Prix, they are well executed. Our pick from those three would be Mind Your Meds. It puts digital tactics at the core, provides not only emotional message but also valuable information.
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Cate Jackson


Brand: Simponi – Janssen
Agency: MCCANN HEALTH AUSTRALIA
Target: Promotional Communication to the Healthcare Professional: New Product Launch
Credits:

Name Company Position
June Laffey Mccann Health Executive Creative Director
Thomas Dirnberger Mccann Health Art Director
Kate Chisnall Mccann Health Art Director
Bob Johnson Mccann Health Art Director
Sophy Myer Mccann Health Account Director
Dick Sweeney Louis/Co Photographer
Glenn Edwards Castirian Editor
Tristan Coelho Composer/Produce

Campaign Description:

When you treat RA with Simponi, it only takes about ten minutes, once a month. This means Simponi is the treatment you hardly even notice. Great news when often RA is burden enough to a patient. We wanted to capture the non-invasive nature of Simponi in our creative. So we set out to capture a month of a Simponi patient on film and show how non-invasive it is. Literally. This film features a typical RA person – female between 50 and 60. It shows hundreds of moments (selected from over 10,000 shots captured by our photographer) that represent a month in the life of a Simponi patient, Cate Jackson. Amongst the hundreds of shots, there is only one that features Cate injecting herself with Simponi. The shots are run together so quickly in the film, it is near impossible to spot the moment that treatment takes place. This technique/idea highlights the fact that Simponi is very non-invasive, so you’ll hardly notice. After watching a collage of her life, a super tells us in the many shots/moments we just watched only one featured Simponi. The super then challenges: “Bet you hardly even noticed. Neither did Cate Jackson.”

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True Cost

[tabs type=”horizontal”][tabs_head][tab_title]Shampoo[/tab_title][tab_title]Tea[/tab_title][tab_title]Toothbrush[/tab_title][/tabs_head][tab]Bayer, Sativex: “True Cost” Campaign “Shampoo”

True Cost - shampoo - sativex
True Cost – Shampoo – Sativex

[/tab][tab]Bayer, Sativex: “True Cost” Campaign “Tea”
True Cost - Tea - sativex
True Cost – Tea – Sativex

[/tab][tab]Bayer, Sativex: “True Cost” Campaign “Toothbrush”
True Cost - Toothbrush - sativex
True Cost – Toothbrush – Sativex

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Brand: Sativex – Bayer
Agency: LANGLAND Windsor, UNITED KINGDOM
Target: Promotional Communication to the Healthcare Professional: Brand Re-appraisal campaign
Credits:

Name Company Position
Andrew Spurgeon Langland Executive Creative Director
Andrew Morley Langland Art Director
Harry Yeates Langland Copywriter
Andrew Morley Langland Designer/Digital Designer
Whitney Andrews Langland Senior Account Director
Elizabeth Chambers Langland Group Account Director
Graham Robinson Langland Account Manager
Claire Martin Langland Art Buyer
Jessica Stonell Langland Art Worker

Campaign Description:

Spasticity is a symptom that develops late in the course of multiple sclerosis (MS), causing muscle spasm, weakness and stiffness. Patients lose their independence and are forced to rely on family members and carers to accomplish basic tasks. The limited treatment options have significant side effects, or require an implanted pump.
Sativex is a novel treatment developed from particular strains of cannabis that significantly improves symptoms of spasticity in responders. Because it is delivered as an oral spray, patients can adjust their dose as and when they need to. However, HCPs have been equivocal about its value, and concerned about its cost.
To drive re-appraisal of the brand among prescribers, we used the unifying idea of ‘cost’ to bring together the effect of MS spasticity on patients with its broader social impact and the financial realities, increasing their motivation to gain budget approval for Sativex.

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Mind Your Meds

The Medicine Abuse Project - Mind Your Meds
The Medicine Abuse Project – Mind Your Meds

https://www.youtube.com/watch?v=BJ4kKv9-yb4

Brand: MEDICINE ABUSE PROJECT – Partnership at Drugfree.org
Agency: HILL HOLLIDAY Boston, USA
Target: Communications to Non-Healthcare Professionals
Credits:

Eric Stoltz Disorderly Conduct Director
Lance Jensen Hill Holliday Chief Creative Officer
Scott Woolwine Hill Holliday Designer/Animator
Kevin Daley Hill Holliday Group Creative Director/Art Director
Trish Fuller Whitehouse Post Editor
Tim Cawley Hill Holliday Creative Director/Copywriter
Alejandra Alarcon Disorderly Conduct Producer/Post Producer
Crash Disorderly Conduct Cinematographer
Amy Hardcastle Hill Holliday Account Team
Jenn Dodds Hill Holliday Project Manager

Campaign Description:

Teen medicine abuse is a pervasive and devastating problem, with one in four teens admitting to using a prescription drug to get high or change their mood. Most teens who report medicine abuse say they get those medications from their family or friends. The Medicine Abuse Project is a multi-year effort led by The Partnership at Drugfree.org and is designed to help combat this public health crisis deemed an “epidemic” by the Centers for Disease Control and Prevention. The Medicine Abuse Project aims to help educate parents, teens and the public about the dangers of medicine abuse and unite parents, educators, health care providers, coaches, government officials, law enforcement officers and other partners to help save lives.

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Click for the full list of Cannes Lions Health contenders and awards in Pharma category.
 

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Pharma Marketing

Gartner Cool Vendors in Life Sciences 2014 – are they really cool?

Gartner Cool Vendors in Life Sciences report may be a good predictor of what will be a hot topic in pharma. But what Gartner Cool Vendors in Life Sciences 2014 really do? Is it really worth to jump the bandwagon right away?

Why Gartner Cool Vendors in Life Sciences and similar reports are important?

The mode of action is simple, consultants from Gartner and other agencies are basing on similar rankings with their sales pitches. As Richard Meyer points out, pharma marketing insiders are not the best breed.
If the sales pitch sounds good and has a supporting proof in an expensive research report, your average pharma marketer will swallow it like a hungry pelican. In the effect, any company mentioned by big consultancy has a chance to gain market and its product may be listed as a rising trend for the year to come. Regardless of the value generated for business. While you look into the Gartner Cool Vendors 2014 list, you may guess what it will be about this time.

Gartner Cool Vendors in Life Sciences 2014

Blueprint Clinical

Blueprint Clinical - Gartner Cool Vendors in Life Sciences 2014
Blueprint Clinical

Blueprint Clinical is an U.S.-based monitoring technology company founded in 2012. It’s team has a profound experience in healthcare, and especially in clinical trials. Courtney McBean, CEO of Blueprint Clinical, has over 15 years of experience in research and medical devices business.
The main product of Blueprint Clinical is web-based product called Blueprint Compass for risk-based statistical monitoring of the study performance. It provides real-time monitoring of site performance, focusing on metrics critical for the study and with possibility to assign targeted actions to relevant performance indicators.
R&D and Clinical Research is obviously the huge chunk of pharma spending, and risk-based monitoring as such is required by FDA.  Does Blueprint Clinical answers the need for that well, it is hard to assess. So far the company provides its service together with consulting service, which means that it is rather customized offer than a mature, standard service.

Liquid Grids

Liquid Grids - Gartner Cool Vendors in Life Sciences 2014
Liquid Grids

This one is, to be honest, a very surprising choice. Liquid Grids, a Gartner Cool Vendor in Life Sciences 2014 is PaaS solution for social media monitoring and engagement (well, they call it a “precision marketing”). Started in 2010, Liquid Grids positions itself as dedicated to health care industry. It claims that it offers “direct to patient” marketing. The problem is that from the global perspective it means a clear no go.
Pharmaceutical marketing directly to consumer is allowed only in specific markets, specifically the United States and New Zealand. What is more, from European perspective any attempt to obtain personal data and target communication to the patient without direct consent is clearly illegal.
It may be a cool vendor for Gartner, but for any pharma marketer outside of U.S. working with Liquid Grids may end with a very cold shower from your legal team (or even worse from the regulatory agency). Let us be clear, for pharma digital marketers it is extremely hard to implement even social media monitoring for product related keywords, as there is a constant awareness of drug safety obligations.

Ontoforce

Ontoforce is one of the big data vendors. Founded in 2011 company from Belgium as its main product offers a semantic search engine disQover.
Clearly, making the tons of data we have gathered in pharma searchable in a contextual way that allows discovery of unknown connections is something that may change the paradigm of research. While we are sceptical about replacing scientific method with brute force statistics on big amounts of data, there is a potential there to find new insights. On the other hand, even if Ontoforce is really Cool Vendor, the competition in this field is very strong

Pitcher

 

Pitcher is another surprising choice. eDetailing is obviously a big trend, but Pitcher is not the only one in its field. We can easily name strong contenders (or even leaders) with similar feature set. Veeva, Agnitio, Showpad and Cegedim are all offering the same service as Pitcher. We love disruptive startup companies entering digital marketing space in healthcare, but Pitcher has yet to prove its coolness.

Scigilian Software

Scigilian Software - Gartner Cool Vendors in Life Sciences 2014
Scigilian Software – Gartner Cool Vendors in Life Sciences 2014

Scigilian is a cloud-based software platform for managing logistics of Pharma R&D. At K-message we are specialized in digital marketing, and we cannot assess this tool capability, but the sales pitch sounds very well. Normally we could build an ERP or LIMS system for such purpose, but the solution would never be ideal. ERPs are too complex and hardly customizable, and LIMS would not cope with the complexity. The solution is to build your own software, or… ask Scigilian. Being outside of the lab, we really like the idea.
As you may see not all of the Gartner Cool Vendors in Life Sciences 2014 are cool enough to make us excited. The trends are clear, however. In pharma marketing the focus is on e-detailing, CLM and Social Media Management. In R&D hot topics are big data, clinical research support and logistics for labs.
Be prepared, consultants are coming!
 
 
 
 

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Pharma Marketing

Pharma digital marketing in the U.S. Spending more and wrong.

The US Healthcare and Pharmaceutical Industry 2014: Digital Ad Spending Forecast and Trends, a new report from eMarketer shows that Pharma Marketing spending on digital remains on steady 3.0% of the total digital ad spending level. Unfortunately half of it is spent wrong.
This has been a common joke of marketers and advertisers for a long time: If I only knew which half I spend on wrong tactics I would make myself and my company rich. However, jokes aside, at K-message we can clearly see which quarter of this budget is going wrong way. We talk serious money here, healthcare and pharma ad spending is now at USD 1.41 bn level, and by 2017 we will pass the threshold of two billions.

US Healthcare and Pharma Industry Digital Ad Spending 2012-2018. Source: eMarketer.com
US Healthcare and Pharma Industry Digital Ad Spending 2012-2018. Source: eMarketer.com

eMarketer takes into account all healthcare and pharmaceutical digital marketing spending in the United States. It includes prescribed (Rx) and over the counter (OTC) products, specific products and services addressed to healthcare professionals, as well as direct to consumer advertising of products, services, hospitals, health insurers etc.
More than half of this budget (56%) goes for direct response advertisement. The remainder of 44% is spent on branding campaigns. This is an artificial segmentations, as the objective of campaign usually is not so clear in the American, DTC driven market. Every branding effort may bring direct response.
What is more striking in eMarketer’s report is the share of spending on healthcare and pharma digital marketing by channel. It seems that mobile is still an ugly duckling for pharma marketers, who dedicate only 26.5% of their budget to mobile formats.
It is incredible if you look at this from the perspective. The same crowd that claims “we want more direct response and we spend more than half of our budget for it” in the same time neglects the channel that is the best to accomplish this objective.
Healthcare and pharma marketing is the single industry that spends on mobile the smallest chunk of its budget. Even PC makers spend 33% of their budget on mobile, but we in Pharma remain connected to the desktop. If we go mobile, pharma marketing focus mostly on mobile search advertisement.
US Digital Ad Spending by Industry and Channel 2014, Source: eMarketer.com
US Digital Ad Spending by Industry and Channel 2014, Source: eMarketer.com

We can try to persuade ourselves, that there is some logical reasoning behind this inefficient budget allocation. However, at K-message we tend to believe that the only reason to avoid mobile advertising in pharma is simply change-aversion. Mobile advertisement is well regulated, rules are clear, and results are easily measurable. It allows better interaction than PC in many dimensions: it can be geo-located, instant, personalized. The only disadvantage over display ad on PC screen? It requires additional work.
Digital marketing is not a rocket science that Pharma R&D are performing. You can start simply with text messaging in your next multichannel campaign. Make sure that your next edetailing is part of the CLM. Give your audience some thrill with elements of gaming. Do not fly everyone to the remote conference site, use virtual one instead. This is pharma digital marketing, not putting banners every here and there.
We really hope that pharma marketers will surprise eMarketer by proving they know how to use digital marketing tactics efficiently. Fingers crossed!

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Pharma Marketing

Text messaging in multichannel pharma marketing

Multi-channel marketing strategies usually include old tactics such as telemarketing, direct mailing and printed detail aids to accompany more fancy mobile applications, eDetailing on tablets and over the Web. Good old SMS text messaging is forgotten in the era of smartphones. Is it really so smart?

SMS in pharma marketing

Text messaging is a tactic that pharma marketers used in the past. There were successful pharma marketing campaigns with text messaging at the core of the execution.
One such example is Pfizer’s recruitment for a study that targeted teenage smokers with a radio campaign. The call to action instead of traditional “call us now” was replaced by “text us now” which allowed young audience to discreetly make a contact with researchers, even if they listened to the spot in their (unaware of teen’s deadly habit) parents’ car.

Novartis with its SMS for Life campaign allows better access to malaria treatment in Africa. A successful pilot in Tanzania that has been running since 2009, has encouraged the company to roll it out in other markets, including Kenya, Ghana and Cameroon. So far the results were very impressive, allowing company to reduce stock-outs of the antimalarial ACTs from 26% to just 1% of the facilities.
GSK is using text messaging to increase childhood vaccination rates in Mozambique and to fight counterfeit products in Tanzania. Merck is running a diabetes sms campaign in Kenya and Uganda…
But wait a moment, it is all just marginal actions, and never the core of the brand strategy in the product lifecycle. It seems that text messaging is no longer considered as a part of still trendy mobile marketing. Ask your average pharma marketing expert for mobile tactics, and you will get a standard list:
– build a mobile app
– build a mobile or responsive website
– make your e-mails mobile ready
This is all fine, but:
– a mobile app is usually a costly mistake that with limited reach and extremely short lifespan
Only 30% of apps is downloaded. Of those, only 30% is ever opened. For free apps, only 5% are still being used after one month. Astonishing 80% of mobile apps have less than 1000 downloads.
Yes, you can be lucky and make an app that is actually useful and used, as Merck was with its Clarityn’s Pollen Forecast app. But if you are in the Rx world, there is a very slight chance that a mobile app will work for you.
– a mobile or responsive website is good to have, but to convey a scientific message you need a big screen anyway. Check your current web entities for stats of mobile usage and you will be surprised how rarely HCPs are visiting it with the mobile device that is not a tablet. And for tablets, a standard website is perfectly fine.
– the e-mails are often read on mobile, that is true. Therefore, it is worth an effort to make your e-mails mobile friendly, but never stop here. If your e-mail reached a user on the mobile, the landing page should be optimized for mobile as well. Do not expect anyone to read a scientific paper on an iPhone or, even worse, Blackberry. Instead make the user journey mobile end-to-end – let them order delivery of the paper with one tap, rather than providing a download button as you would do for PC or Mac users. Limit length of the survey, make sure the landing page is light on text, etc. etc.
What your consultant probably forgot to add, a text message is much more friendly for phone users than e-mail. It can be even richer in content, especially if you decide to embed in your campaign OTT messages.
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Text message marketing vocabulary
Short Message Service (SMS) – the oldest standard for text messaging. It allows sending 160 characters, plain text. It is extremely cheap and can be very narrowly targeted. It can reach every phone, which gives you maximum potential reach. Arriving SMS is accompanied with buzz sound set by the user, thus it is important to set silent hours for SMS campaigns.
Multimedia Messaging Service (MMS) – a standard to send messages with multimedia content to and from mobile phones. MMS can convey messages much longer than SMS, up to thousands characters or up to 1MB content. Unfortunately, its implementation differs from operator to operator and from device to device. Quality of the video and its length is also restricted, so limit yourself to 30 seconds, or use OTT instead.
Push notification – a service that allows an app installed on the device alert user with a message.If a push notification is received, an app will display it with its icon on the status bar of the device. It is useful for e-commerce applications (ie. while searching for an item, you may receive a push notification with a special time-limited offer from the merchant nearby). Unfortunately, the reach is limited to smartphones. On the other hand, users are keen on accepting Push while installing an app easier than to opt-in for SMS campaigns. Push is also cheaper than SMS.
Cross-channel messaging – messaging service can be used to seamlessly put content on other channels (ie. it is possible to receive and post Facebook comments via text messages, or use MMS to upload images on Flickr).
Over-The-Top messaging (OTT) – messaging with multimedia content that is enabled by mobile applications not associated with mobile operators (ie. Apple iMessage, WhatsUp, Blackberry Messenger). Messages are downloaded via data connection. If WiFi is used to send/receive OTT messages, it allows geolocation of the device. The best practice is to combine SMS/MMS with Push and OTT services.
Instant Messaging (IM) – real time text based communication over the Internet. From a mobile device it is non-discernible from OTT, and in some applications also merged with SMS/MMS service in one application view.
Short Code – a short, 5-6 digits, number for standard and premium rate use on assigned territories. Used for mass marketing campaigns. You can use a shared short code from your vendor to launch your campaign faster, but it will limit available keywords (each can be used only once per code). The best practice is to register single short code for your brand, especially in the long term campaigns.
Long Code – 10 digits phone numbers, as used by standard subscribers in person to person communication. They may be used for campaigns that happen across different territories, but the limitation is the amount of messages that can be processed via long code at the time.
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Advantages of SMS marketing for pharma and mobile health

 
Forgotten by external consultants in the age of pharma cross-channel marketing, mobile messaging is still alive and growing. Actually, it is the most-used non-voice channel in the world, with 14.7 trillion messages sent worldwide in 2012. With the rise of OTT and IM applications the growth of this way of communication may be even faster than expected, going well beyond an estimated 28.2 trillion threshold by 2017.
Everyone gets now text messages from banks after transactions, from airlines when the flight is ready to board, from retailers who offer us their special deals. Pharma marketers could learn from their clients how to use text messaging.
Healthcare providers are sending messages to:
– manage appointments,
– provide information,
– inform on the prescriptions
– remind patients that there is some FSA money left to be spent before the end of the year.
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For non-US readers:
FSA stands for Flexible Spending Account and allows to pay for some medical and dental procedures or products and deduct it from the tax
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Pharmacies are sending out pick-up notices, links to package inserts content, and allow text-to-refill service to their customers.
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SMS and mobile messaging advantages for pharma marketing:

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  • Improved relevance: Message can be easily tailored for the specific recipient, embedding itself into the CLM concept with tracking capabilities.
  • Cost efficiency: Efficiency much better than e-mail notification in terms of Open Rate (~90%). Response rate is also very high ranging from 5 to 25%, around eight times better than for e-mail.
  • Always within context: Text messages are opened at the time of receipt. You can make sure that the message content is aligned to the schedule (or even location with Push and OTT) of your recipient.
  • Providing value through the whole process of customer relationship management, from the initial opt-in confirmation at an appointment, through reminders to thank you messages. Always interactive and fully tracked!
  • Compliant: SMS/Texting follows similar pharma/healthcare industry regulations as other communications channels.

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Use cases for text messaging in pharma marketing and medical affairs:

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  • Patient recruitment for clinical trials
  • Patient adherence (in clinical trials and after marketing authorization during therapy)
  • HCP and Sales Representative relationship: appointments, reminders, additional information in two-way communication

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How to make a text messaging campaign that converts?

 
If you reached to this point, you are probably convinced, that text messaging is the tactic to include in your strategy. That is fine, but to make sure you are successful, we have prepared some tips and tricks, that will make your campaign better. We are all about digital marketing, so we assume you know the basics – your KPIs are already defined, and you will measure your conversion rates. So how to make sure your text message will convert?
Some of the tips are no brainers, but differ a bit in messaging campaigns from an e-mail world.
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Tips for converting text messaging campaign

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  • Carefully consider timing of the campaign. With an e-mail, you targeted specific days of the week. With mobile campaigns, you need to be perfectly clear about an hour (and a time zone!) when the message buzzes in your audience pockets.
  • Targeting your audience is similar to what you do in other digital channels. However, your text message will probably come from the same code through the campaign, and your audience may respond. To ensure success, first shape your communication to the audience group (ie. cardiologists), then make a tree of possible reactions and answers to them.
  • It is somewhat similar to what you would do providing a script for telemarketers. You need to think about the message as a part of longer conversation. Never repeat the same message, always refer to the previous state, and make the user journey interesting with different call-to-action.
  • Whenever you can, do A/B testing of your messages. We are aware you need to submit them to the regulatory, thus submit different versions of the message, just in case the original one is not working as well as supposed.
  • Call to action is really important, especially if you have 160 characters, and you need to make sure that there is a Fair Balance in your message. Therefore, try to embed your messaging into other elements of the campaign. The most important will always be the landing page, but text messaging allows more response types than other channels.

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After receiving and viewing your message, recipient can:
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  • call back (make sure there is a call center ready)
  • schedule an appointment with rep
  • start remote detailing
  • order samples or research paper delivery
  • watch video, document or website content
  • download an app or bookmark page
  • share some content via social media or e-mail
  • answer a short survey
  • enroll to the program
  • opt-out from the communication (you have to always provide this possibility!)
  • probably you can imagine some other responses as well

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As you can see there is a lot that you can do with simple message, and the more options you have in your campaign, the better results. You just need to test and fine-tune your campaign to select what works the best to deliver your key message and build valuable conversation with your audience.

Regulatory constraints for an SMS marketing in Pharma

As with every pharma marketing tactic, you must be aware of certain regulatory constraints while planning your text messaging campaign. The most important document to follow is CTIA Compliance Assurance Solution Mobile Commerce Compliance Handbook.
For U.S. run campaigns, you also need to be compliant with TCPA, HIPAA and (if you address children) COPPA regulations.

The key considerations from a regulatory compliance perspective for use of text messaging in pharma marketing:

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  • You have a permission from the consumer to send messaging from your company (Prior Express Written Consent)
  • The short code used is the same for which consumer opted-in
  • Your campaign has been approved by carriers
  • All medical information is governed by HIPAA in terms of privacy protection
  • Consumer has always an opportunity to opt-out from all communications and is always informed about any cost that may be charged against him due to participation in your program.
  • In the U.S., according to 21 CFR 314.81(b)(3)(i), all advertisements and promotional labeling for a particular drug product must be submitted to the FDA at the time of initial publication or dissemination.  Each submission is required to be accompanied by a completed transmittal Form FDA-2253.

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Rich Communication: the future of mobile marketing

Mobile messaging campaigns with SMS, MMS, Push and OTT is already very efficient channel. However, the technology is going forward, and new capabilities are being rolled out. Rich Communications Services (RCS), marketed as “joyn”,  is the platform that enables the delivery of communication experiences beyond voice and SMS, providing consumers with instant messaging or chat, live video and file sharing – across devices, on any network.


With RCS, we will be able to combine in one interaction a message, video, call, and remote detailing. Joyn does not need any additional setup from the end-user. It is provided by a carrier and ready to use within compatible devices. Supported by GSMA, the technology is already being rolled out across the globe. This new standard will be yet another reason to think “messaging” as the first option where it comes to mobile marketing.

Categories
Pharma Marketing

Hard Trends for Innovation in Pharma Marketing

Success in pharmaceutical industry depends on innovation. We are in the constant race with mutating microbes, viruses and cells. New regulations, stakeholders and disruptive competitors are changing industry landscape every day.

Innovation
Innovation (Photo credit: Thomas Hawk)

At the recent Pharma Customer Experience Management Summit in Berlin, where I was one of the speakers, the innovation was a leitmotif. One particularly strong accord was played by Alexander Simidchiev from GSK. In his presentation, Customer-Centric Approach in Pharma: Future of Healthcare?, Alex has pointed out what I believe is the best approach to smart innovation in pharmaceutical marketing.
Inspired by Daniel Burrus’ methodology described in the book Flash Foresight, Alex advises pharma marketers to look for the “hard trends”.
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Hard trend is a projection based on measurable, tangible, and fully predictable facts, events, or objects. It is something that will happen: a future fact that cannot be changed.
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In the day to day practice of pharma marketing we can often see urge to innovate based on the opposition of the hard trend. Something, that Burrus would call a “soft trend”, something, that only might happen.
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Soft trend is a projection based on statistics that have the appearance of being tangible, fully predictable facts. It’s something that might happen: a future maybe.
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Such “soft trend” is easy to be sold by marketers and consultants. You may hear that we should go mobile (the smartphones are on the rise, aren’t they?). You may learn, that eDetailing on tablets is a must (everyone has an iPad, buy one too, quickly!).
It is not a bad thing to identify such soft trends and use them for your innovation. The thing is, however, that soft trend can be influenced and changed. It is the change of this trend that innovator should capitalize on. Followers of those soft trends risk being punished with the next disruption.
However, such approach is not enough. As Alexander Simidchiev said, basing on his experience in pharmaceutical industry, for K-message.com:

Most of what I currently percieve is cosmetic changes in the industry which has changed little since the hayday of anilin based medical wonders, currently addressing mainly short term priorities and tactical issues. The result is that the industry chronically suffers from suboptimal reputation, and we are always “on the back foot” trying to defend past practices, instead of treading the virgin soil (together with other partners and stakeholders) of how to overcome the current challenges facing the healthcare system, for which (my personal deep belief) pharma is one of the possible, if not dominantly positive solutions. This requires that current marketing practices refocus from talking product to joint solutions for societal needs.

To be prepared for what will happen, you need to look at hard trends. This will not change, and it provides a solid foundation for growth. Hard trends are derived from demographics, regulations and technological advances (in terms of growth of “three digital accelerators”: processing power, storage and bandwidth).
Alexander Simidchiev in his presentation has applied this approach to look at pharmaceutical industry. Hard trends derived from demographics facts are stunning. Simple combination of current knowledge of age profiles for public expenditure on healthcare in EU countries (how much is spend for the healthcare of people in certain age), with data on ageing of the population shows, that current system cannot be sustainable in the near future.
 

Age profiles for public expenditure in health. Economic Policy Committee (2001) “Budgetary challenges posed by ageing populations” p. 34 [PDF]. An arrrow added by K-message.com
Age profiles for public expenditure in health. Economic Policy Committee (2001) “Budgetary challenges posed by ageing populations” p. 34 [PDF]. An arrrow added by K-message.com
On the other hand the same fact of ageing population affects how HCPs of today are working. 2014 was a tipping point, when the majority of HCPs in the EU is digitally native. All newly qualified doctors now, were born after 1988, and started their studied in 2005, which means they used the Internet to learn medicine (PubMed has started in 2006). They find digital more natural than printed materials for acquiring professional knowledge.
Those are hard trends, not guesses, and pharma marketers have to face it or their companies will struggle. We need to be prepared for dramatic shift in our business model, with less money for much bigger population in public healthcare system. We have to use digital channels to be understood by new generation of HCPs, and to provide information the new, digitally savvy patients.
It is not about nice mobile apps or shiny presentations on iPad. It is about the future. As Alexander Simidchiev, quoting Peter Drucker, has closed his presentation: The best way to predict the future is to create it.

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Pharma Marketing

Do not join the Dallas Buyers Club. Expanded Access explained.

Dallas Buyers Club is a powerful movie. Based on true story of Ron Woodroof it shows how patient has to fight the system instead of receiving a treatment for the deadly disease. Everything seems to ally against suffering patient. Health Care Professionals driven by greed offer inefficient therapy under strict clinical trial regime. FDA officers are enforcing cruel regulations confiscating “illegal” but life-saving medications. Even the judge from liberal California, although compassionate is forceless. Dallas Buyers Club is a coalition of suffering people turned into outlaws for trying to save their lives.
Is pharmaceutical industry and its regulators really so cruel? Why Woodroof and his club were persecuted instead of receiving help? Is it possible that such story happens today with some other disease?

Clinical Trials – Why Ron could not get AZT in the proper dose in the hospital.

At the moment depicted in the Dallas Buyers Club, AZT (zidovudine, also known as azidothymidine, trade name Retrovir) in the U.S. was in the clinical research, probably in Phase III of the process.
 

English: AZT (zidovudine), the first medicatio...
English: AZT (zidovudine), the first medication shown to be effective against HIV. From the National Institutes of Health website. (Photo credit: Wikipedia)

 
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Phases of Clinical Research

[checklist]

  • Phase 0:  The first in-human research of new drug is called an exploratory investigational new-drug study or phase 0 study. It is done before traditional phase I trials. Smaller than therapeutic doses of a new drug are given to a small group of patients (typically fewer than 15) for roughly a week to determine pharmacodynamic and pharmacokinetic properties.
  • Phase I: Researchers test a new drug or treatment in a small group of healthy volunteers for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
  • Phase II: The drug or treatment is given to a larger group (about 100 -300) of people who have the disease or condition that the product potentially could treat. In this phase researchers see if the medicine is effective and are able to further evaluate its safety.
  • Phase III: The drug or treatment is given to large groups (1000 to 3000) of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
  • Phase IV: Studies are done after the drug or treatment has been marketed to gather information on the drug’s effect in various populations and any side effects associated with long-term use.

[/checklist]
 
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Phase 2 and Phase 3 clinical trials generally involve a “control” standard. It means that some of the participants do not get tested substance, but inactive placebo or other, existing treatment if available. To avoid any bias, there is a special process to randomly decide who gets a tested substance, called randomization. At this point no one knows if the new therapy is efficient or maybe dangerous, so getting placebo is not necessarily worse option. Additional process to avoid bias in the results of the research is called blinding. Single-blinding means, that patients do not know whether they are treated with tested substance. Even better procedure, double-blinding means that also the research team does not know who receives what. Patient is informed about the substance s/he receives only at the specified time of the study, when it cannot impact the results.
Due to this procedures, it is not possible for patient to decide a dosage or even to be sure that the specific drug is given. In the story of Dallas Buyers Club, Ramona starred by Jared Leto could not be sure that her medicine is AZT and not just placebo.
Clinical studies are necessary to identify adequate dosage and eliminate risks that could overwhelm benefits of new therapy. There is always limited number of participating patients with specific conditions, so it takes long time to gather representative sample and see the results of the study. The whole process takes years to be completed, but it is needed to approve new drug to be available on the market.  

Expanded access – Would it be possible to import medicine for Ron legally?

AIDS patients could not wait for clinical trials, this is why Dallas Buyers Club and other similar communities existed. In that time, there was no easy, legal way to provide access to the treatment for patients in need. This experience affected current regulations in the U.S., and now there is a number of ways that allow access to the investigational or non-approved therapies for serious or life-threatening conditions, including but not limited to HIV/AIDS. Additionally, there is a way to expedite process of approval for the treatment in so-called FDA fast track drug development program.

Access to Investigational Drugs Outside of a Clinical Trial (expanded access)

Expanded access, sometimes called “compassionate use,” is the use of an investigational drug outside of a clinical trial to treat a patient with a serious or immediately life-threatening disease or condition who has no comparable or satisfactory alternative treatment options.
FDA regulations allow access to investigational drugs for treatment purposes on a case-by-case basis for:
[checklist]

  • individual patients, including in emergencies

  • intermediate-size patient populations

  • larger populations under a treatment protocol or treatment investigational new drug application (IND)

[/checklist]

To permit treatment of a patient with an investigational drug under an expanded access program, FDA requests following conditions to be met:

[checklist]

  • The patient’s disease or condition has no satisfactory approved therapy. An example of this is a rare type of cancer that has no known or approved treatment. Or, it may be the case that the available treatments did not work for the patient.

  • The potential benefit for the patient justifies the potential risks. An example of this is the potential for longer survival with a disease or condition.

  • The expanded availability of the untested drug will not interfere with that product’s development. For example, access to an investigational drug should not interfere with enrollment in clinical trials needed to demonstrate the drug’s safety and effectiveness.

[/checklist]

Additionally, the drug manufacturer and the patient’s doctor must make special arrangements to obtain the drug for the patient. These arrangements must be authorized by the FDA. These safeguards are in place to avoid exposing patients to unnecessary risks.

Just as in clinical trials, these investigational drugs have not yet been approved by the FDA as safe and effective. They may be effective in the treatment of a condition, or they may not. They also may have unexpected serious side effects. It is important for you to consider the possible risks if you are interested in seeking access to an investigational drug.
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How to Get Expanded Access to an Investigational Drug?

The process must begin with your healthcare provider, who should follow these steps:
[checklist]

  • Your healthcare provider must contact the company that manufactures the drug to make sure it is willing to provide the drug.

  • Your healthcare provider must submit an Investigational New Drug (IND) [link to section below] application to the appropriate FDA review division.

  • In an emergency situation, the request to use the drug may be made via telephone or other rapid means of communication, and authorization to ship and use the drug may be given by the FDA official over the telephone. With emergency INDs, shipment of and treatment with the drug may begin prior to FDA’s receipt of the written IND submission that is to follow the initial request.

  • In a non emergency situation, the IND must be received by FDA before shipment of and treatment with the drug may begin. These non emergency requests are known as individual patient INDs.

[/checklist]

The IND Application

The IND application is required to gain access to an investigational drug outside a clinical trial. The application should include the following information:
 

  1. Statement that this is a request for an individual patient IND for treatment use (specifying whether it is an emergency IND or individual patient IND), which should be included at the top of the correspondence and on the mailing cover.

  2. Brief clinical history of the patient including:

    • Diagnosis

    • Disease status

    • Prior therapy

    • Response to prior therapy

    • Rationale for requesting the proposed treatment, including a list of available therapeutic options that would ordinarily be tried before the investigational drug, or an explanation of why use of the investigational drug is preferable to the use of available therapeutic options

    • Reference for a published protocol or journal article, if appropriate

  3. Proposed Treatment Plan including:

    • Dose (how much and how often)

    • Route of administration (by mouth, injection, etc.)

    • Planned duration (how long the product is to be taken)

    • Monitoring procedures

    • Modifications (e.g., dose reduction or treatment delay) for toxicity

  4. Chemistry, Manufacturing, and Controls Information and Pharmacology and Toxicology Information, including a description of the manufacturing facility. This can be done by providing a letter of authorization (LOA) that refers to this information if it has been previously submitted to FDA (for example, to an existing IND or new drug application). The treating physician should contact the sponsor of the previously submitted information for the authorization and letter. The LOA should include identifying information, such as the sponsor’s application (e.g., IND) number.

  5. Informed Consent Statement noting that informed consent and approval by an appropriate institutional review board (IRB) will be obtained prior to beginning treatment. In the case of an emergency, treatment may begin without prior IRB approval, provided the IRB is notified of the emergency treatment within 5 working days of treatment.

  6. Investigator Qualification Statement that specifies the training, experience, and licensure of the treating physician. The first two pages of a curriculum vitae typically contain this information and are usually sufficient.

  7. FDA Form 1571 completed with the treating physician listed as the sponsor. Download Form 1571 and view the instructions.

[Source: FDA]

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Expedited approval

For the drugs that are the first available treatment or have advantages over existing treatments, the Food and Drug Administration has developed four distinct approaches to make such drugs available as rapidly as possible:
[checklist]

  • Priority Review

  • Accelerated Approval

  • Fast Track

  • Breakthrough Therapy

[/checklist]

Priority Review

Prior to approval, each drug marketed in the United States must go through a detailed FDA review process. Since 1992, under the Prescription Drug User Act (PDUFA) a Priority Review designation is used to the evaluation of applications for drugs that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications. A Priority Review designation means FDA’s goal is to take action on an application within 6 months (compared to 10 months under standard review). Priority Review does not affect the length of the clinical trial period.

Accelerated Approval

It takes many years to fully assess whether a drug provides a real effect on how a patient survives, feels, or functions, and brings a clinical benefit. To make drugs for serious conditions that filled an unmet medical need approved earlier, FDA can use Accelerated Approval process and base its decision on a surrogate endpoint. A surrogate endpoint is a marker of therapeutic effect, that is thought to predict clinical benefit but does not measure it. Drug still needs to be evaluated after approval in Phase IV studies, and basing on the results of this Phase IV FDA can change its initial decision on approval (ie. withdraw one of labeled indication, or completely withdraw drug from the market if confirmatory tests do not prove enough clinical benefit).

Fast Track

Fast track is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need.

A drug that receives Fast Track designation is eligible for some or all of the following:

[checklist]

  • More frequent meetings with FDA to discuss the drug’s development plan and ensure collection of appropriate data needed to support drug approval

  • More frequent written correspondence from FDA about such things as the design of the proposed clinical trials and use of biomarkers

  • Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met

  • Rolling Review, which means that a drug company can submit completed sections of its Biological License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the application is completed before the entire application can be reviewed.  BLA or NDA review usually does not begin until the drug company has submitted the entire application to the FDA

[/checklist]

Breakthrough Therapy

Breakthrough therapy is the latest program at FDA that will complement the programs listed above. It facilitates and expedites drug development and review for serious conditions and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s).

A drug that receives Breakthrough Therapy designation is eligible for the following:

[checklist]

  • All Fast Track designation features

  • Intensive guidance on an efficient drug development program, beginning as early as Phase 1

  • Organizational commitment involving senior managers

[/checklist]

[Source: FDA]

 

British MHRA’s Early Access to Medicines

Early access to the innovative drugs is still a topic for regulators not only in the U.S. In the United Kingdom the latest development is an Early Access to Medicines program unveiled by the Government on 7th of March 2014. The program aims to accelerate access to innovative medicines for serious conditions, allowing doctors to prescribe the drugs after an initial scientific assessment by the Medicines and Healthcare Products Regulatory Agency (MHRA).
The program, funded by pharmaceutical companies, will be launched on April 2014. Suitable drugs  will receive a “promising innovative medicine” (PIM) designation. PIM designation will be  based on several years of clinical data assessed by MHRA, but before completion of Phase III trials. This will probably save several years in comparison to the standard process for approval, that will be run in parallel to the new program.
Early Access to Medicines is modeled after the FDA’s breakthrough therapy designation. British regulatory agency estimates that one or two therapies could be designated under the scheme each year. 
It seems there is no need for Dallas Buyers Club anymore.

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Digital Health MedTech Pharma Marketing

How Quantified Self, mHealth and Wearable Technology are Changing Pharma Marketing

Quantified self, mHealth and wearable technology. While you could hear about those trends in the past, the tipping point has been reached at the CES 2014. What was supposed to be the future is our present much faster than industry expected. Enterprise market is again far behind consumers. Health care industry tethered by regulations just cannot catch-up quickly enough.

At K-message however, we can take a look at the forefront of the consumer technology and assess its possible impact on the industry, and our focal point – pharmaceutical marketing. But first, let us define what we are talking about.

What is quantified self? Who wears technology? What is mHealth?

Quantified self (QS)

Quantified self (QS) is a trend of personal data collection via technology. The idea is to acquire data on person’s state, actions and performance using wearable technology and/or mobile applications.

Track Yourself Map of Quantified self apps by Rachelle DiGregorio

Wearable technology is a description of any electronics that one can wear. It may be something with a sensor for quantified self purposes, but it can be also a T-shirt with LEDs intended just to look nice. From quantified self perspective, wearable technology is a trend that enables the whole movement by devices that can capture personal data.

mHealth is a general term for usage of mobile devices (mobile phones, smartphones, tablet computers etc.) in connection to medicine or health care. mHealth includes providing information to the patients or HCPs, but also collecting patients data.

Is Quantified Self big and mature enough to have an impact on health care industry?

The topic is huge. On the Quantified Self Guide – a website that collects different Quantified Self applications, there are 505 different tools listed at the time of writing this article. Of those 65 are tagged with medicine and 124 with fitness category tag. Wearable technology was main topic of CES 2014. If you look around in the office of any healthcare corporation (or, even better, on the jogging path) in the developed world,  you will notice wearable sensors in form of bracelets, chest bands or small items in the shoes used by increasingly high population. Users of the smartphones install “measuring” applications on their devices.

Gary Wolf: The quantified self


What are the numbers? Runtastic, a mobile app dedicated to track running performance has recorded 60 million downloads worldwide and 25 million registered users on Runtastic.com. Similarly targeted device and app Nike+ platform claims 18 million users. Fitbit.com, the website that allows to see the results of tracking with Fitbit range of devices according to Quantcast has around 2 million users from the U.S. only. Quantified Self is definitely mass market now and it will not fade away. Instead it seems it will get more devices and applications as the tech industry embraces it.

Quantified self: dangers versus benefits

From the pharma marketer perspective quantified self may be even more disruptive than the raise of social media (which, by the way is still not accommodated properly). As it gives more knowledge to the user it takes away control from the HCPs. Fitness trackers are obviously beneficial as they encourage the best prevention against disease – exercise and movement. On the other hand the trend brings some risks with it.

PBS: The Quantified Self: Data Gone Wild?

Interpretation of the data gathered by the device or application, even if supported with some mHealth resource filled with scientifically proven knowledge may lead to wrong decisions. Innocent life-logging app that counts calories intake may lead to starvation, or at least to non-balanced diet for some users who want to lose weight too quickly (not mentioning here eating disorders). A non-calibrated blood pressure and pulse tracker may put people with cardiovascular issues at risk (I cannot breath but the reader says I can still run…). The device alone can affect users health by allergy (that happened with Fitbit Force recently), heat, permanent exposure to radiation. There was also at least one occurrence when using activity tracking device, and competing for better score was connected with a tragic death of one too motivated biker.
In pharmaceutical industry there is a lot of pressure put on the patient data privacy. Quantified self puts those data in open, sharing the very personal information on the activity publicly, sometimes without informing user about it. This was a real case when Fitbit.com allowed public to see users who were logging their 30 minutes very active sexual encounters.
What is fascinating in Quantified Self movement is how the application can change focus from empowering by giving the knowledge to the patient to enslaving by enforcing control over users behavior. In one of the quantified self business use cases, not related to health care, a QS device called Hitachi Business Microscope worn by office workers was mapping their communication patterns within organization, pinpointing unnecessary meetings, organization social graph and communication issues.

If we take it to the field of pharma marketing, QS may be seen as a great tool to improve patient compliance or to provide personalized healthcare, but also as a menace of higher insurance rates for any misbehavior – be it sitting too long on the couch or having one drink too much.

Yuri van Geest – The quantified self: within 20 years no doctors needed

Quantified self and EHR, EMR and PHR solutions

One of the promising features of the quantified self is possibility to include the data acquired by sensors directly into electronic health records systems (EHR). Electronic Health Record is not exactly what industry widely embraces as EMR – electronic medical record. Although the data gathered, stored and processed in EHR are more or less the same, the source is different. EMR can include only data provided by medical institutions and healthcare professionals.
EHR is open to any source of data. It includes what can be gathered from EMR, but also accepts patient input, quantified self devices and applications feeds and other sources. A specific range of EHR, that includes only data provided and managed by the user (in this case – patient) is Personal Health Record (PHR). The most renowned solutions of this kind are Google Health (decommissioned) and Microsoft Health Vault, but there are also other providers.  

Microsoft HealthVault – an example of PHR
Microsoft HealthVault – an example of PHR

This brings new opportunities as we get really Big Data in EHR, but also some risks. Data in EHR and PHR cannot be really trusted, as they come from not validated sources and can be contradictory.  The sampling (how often you take a data point) is not standardized and quality of the input is questionable. Nowadays, adoption of EHR and PHR is very limited, as is their functionality and usability. However with the growth of the quantified self we can expect rising importance of such hubs for the medical information.

Quantified self and regulatory compliance: HIPAA and HITECH

Quantified self movement adoption is nowadays limited to developed nations, and the biggest market for those solutions is in the United States of America. There are two regulatory bodies in the US that overlook quantified self devices and applications. For non-medical use the main authority is FTC. Privacy and access to the health related data is regulated by HIPAA and HITECH regulations.

HIPAA Compliance Checklist

  • Have you formally designated a person or position as your organization’s privacy and security officer?
  • Do you have documented privacy and information security policies and procedures?
  • Have they been reviewed and updated, where appropriate, in the last six months?
  • Have the privacy and information security policies and procedures been communicated to all personnel, and made available for them to review at any time?
  • Do you provide regular training and ongoing awareness communications for information security and privacy for all your workers?
  • Have you done a formal information security risk assessment in the last 12 months?
  • Do you regularly make backups of business information, and have documented disaster recovery and business continuity plans?
  • Do you require all types of sensitive information, including personal information and health information, to be encrypted when it is sent through public networks and when it is stored on mobile computers and mobile storage devices?
  • Do you require information, in all forms, to be disposed of using secure methods?
  • Do you have a documented breach response and notification plan, and a team to support the plan?

If you answered no to any of these questions you have gaps in your security fence.
If you answered no to more than three you don’t have a security fence.

Quantified self and regulatory compliance: FDA guidance on medical mobile applications

For medical mobile applications relevant authority is the FDA. The Agency considers mobile phone as a medical device as soon as it meets one of the following:

  • It works expressly for medical purposes and offers medical or health-related apps
  • It acts as an effective accessory or component to aid medical health

While assessing medical mobile applications the FDA applies the same risk-based approach as for other medical devices.  The guidance document  provides examples of how the FDA might regulate certain moderate-risk (Class II) and high-risk (Class III) mobile medical apps. The guidance also provides examples of mobile apps that are not medical devices, mobile apps that the FDA intends to exercise enforcement discretion and mobile medical apps that the FDA will regulate in Appendix A, Appendix B and Appendix C.
For many mobile apps that meet the regulatory definition of a “device” but pose minimal risk to patients and consumers, the FDA will exercise enforcement discretion and will not expect manufacturers to submit premarket review applications or to register and list their apps with the FDA. This includes mobile medical apps that:

  • Help patients/users self-manage their disease or condition without providing specific treatment suggestions;
  • Provide patients with simple tools to organize and track their health information;
  • Provide easy access to information related to health conditions or treatments;
  • Help patients document, show or communicate potential medical conditions to healthcare providers;
  • Automate simple tasks for healthcare providers; or
  • Enable patients or providers to interact with Personal Health Records (PHR) or Electronic Health Record (EHR) systems.

Note, that PHR and EHR systems are not covered by the guidance on medical mobile applications.
Here you can see the list of examples of mobile medical applications the FDA has cleared or approved.

This is the list of examples of mobile medical applications for which the FDA will exercise enforcement discretion. Those applications may meet the definition of medical devices but they pose a lower risk to the public in the Agency’s view.

Quantified self: issues to resolve

The quantified self will gain more importance in the healthcare industry. However, there are still some issues to be addressed before embedding them in the marketing strategy. Before building your own application or choosing one from the market consider them carefully.

Tracking versus privacy

Regardless of HITECH privacy considerations, the pharmaceutical company has to be extremely careful about patient data privacy. It has to be absolutely clear to the patient and the organization, that all data are owned by the user of the application and not the company. You need to have users’ direct consent if you are going to aggregate, store, process, or use the data in any way.

Data reliability

Your quantified self-application or device will gather data in connection to patients’ health. Therefore it is important to achieve possibly high level of accuracy and ensure the integrity of this data. It should be also clearly stated what are limitations of the sensors and technology used.

Fallback in case of failure

You need to make sure that in case of failure or loss of the device, patients will still be able to be treated or diagnosed with a fallback solution.

Interoperability

If your application allows data exchange with EMR, make sure it uses open standards, so that it can be used regardless of the health care provider chosen by the patient. This applies also to interoperability with PHR solutions.

Clear guidance for the interpretation of data

Make sure that the data gathered and provided to the patient are not subject to misinterpretation. There should be a clear explanation of the result provided, and if not possible the instruction should point the patient to the HCP who will be able to interpret the data. Even the best result on the application should not encourage patients to be not compliant with the treatment ordered by his doctor.

Co-operation with HCPs

If every patient comes to his GP with gigabytes of life-logging data, there is no time for a proper diagnosis. Valuable information will be hidden in the noise like a needle in a haystack. Not to mention different UIs of the applications and general annoyance with non-standard requests coming out of the blue. To avoid this you need to provide HCPs with clear instructions on what to look for and make sure they will know it at the first glance. Think about a separate dashboard for the physician or even better – distribute the app through the trained HCPs.

Example of quantified self in pharma marketing: Eli Lilly’s Talking Progress.

Talking Progress - Eli Lilly & Company Quantified Self mHealth App Screenshots
Talking Progress – Eli Lilly & Company Quantified Self mHealth App Screenshots

Talking Progress (this name applies for UK & Ireland markets) is an application available for iOS and Android, that was presented by Claire Perrin on the recent Social Media in the Pharmaceutical Industry conference in London.
Talking Progress is dedicated for adults suffering from depression. Using this app patient can record his/her mood to produce progress charts which can track the recovery and help inform discussions with the doctor. It is extremely important, as one of the symptoms of depression is lack of focus and gaps in the memory.


The app also contains useful hints and tips about lifestyle changes as well as information on causes of depression and treatments.
Talking Progress Features:

  • Educational information about depression
  • Mood Diary
  • Note pages
  • Healthy living advice
  • Medicine reminder alarm

Together with an app Lilly provides a booklet for the patient and small information desk stand for the HCPs. Embedding quantified self elements (diary and note pages) with mHealth features (educational information, lifestyle advice and compliance reminder) makes this app a perfect companion for patients suffering depression. Providing HCPs with the information pack (they are supposed to “prescribe” an app) guarantees that the data gathered via the app will be used and understood by the doctor.

 Quantified self in pharma marketing – an opportunity for everyone

It looks like the quantified self movement will stay with us for longer. Lilly’s example described above shows that properly used it may be beneficial for all – patients, HCPs and pharmaceutical industry. We can without doubt add payers to the list. Correctly applied quantified self is great way for prevention via changing lifestyle habits, increasing disease awareness and improving patient’s adherence to the prescribed treatment. Will we use this opportunity? Quantified self may save lives and money. It seems that even regulatory bodies are up to date with the trend, so the only thing missing is pharma marketers involvement. Do you plan to include quantified self and mHealth elements in your brand strategy?

Categories
Pharma Marketing

Top 3 Key Lessons on Social Media in the Pharmaceutical Industry

On 22nd and 23rd of January in London I was honored to be a speaker at the Social Media in the Pharmaceutical Industry conference. Now back in Swiss Pharma capital city – Basel, let me summarize the key lessons on the social media in pharma industry I took back from the United Kingdom.

Social Network Analysis book cover [social media in pharmaceutical industry]
Social Network Analysis book cover (Photo credit: Matthew Burpee)
First of all, the event itself was really worth to attend. If you heard alarm bells buzzing on the bullshit bingo sequence of social media in pharma, this time it would be a false alarm. Not because of my humble presence, but because of the other participants and the content of their presentations. The chairwoman of the event, my ex-colleague at Roche, now enjoying freedoms of the external consultant, Alexandra Fulford (@pharmaguapa) made sure that we were not lost on the way. Having said that, let us digest the content of the conference.

Social Media in Pharmaceutical Industry Key Learning #1: Social Media is not a marketer’s toy, but a source of powerful intelligence data. A Big Data!

A diagram of a social network [social media in pharmaceutical industry]
A diagram of a social network (Photo credit: Wikipedia)
My senior colleague from Roche, Dr. Alfred R. Steinhardt now in the hat of PA Consulting Group and his own Alfred Steinhardt Consulting, showed us an incredible power of the Social Media used not for standard “what they said about us”. Dr. Steinhardt provided example of social media used by pharmaceutical industry for recruitment to clinical trials (social patient). We could also see social media as a tool to identify and engage with Key Opinion Leaders (in this new world, aren’t they rather Influencers?) who do not necessarily recruit from academia as in the past. Maybe most striking, even if not the most common usage of Social Media was tracking origin of counterfeit drugs sold online.
As we discussed after the presentation, Social Media is not such a big revolution as some pundits say and it will not replace scientific method with statistical analysis of huge amounts of data. Still it is an extremely useful tool that should be looked at out of plain pharma marketing perspective. Which was further confirmed by Dr. Sherri Matis-Mitchell, an Associate Principal Information Scientist R&D Information at AstraZeneca Pharmaceuticals. Dr. Matis showed us how Social Media, when properly used, can provide important answers to R&D teams in pharma industry and help identify unmet needs of patients.

Social Media in Pharmaceutical Industry Key Learning #2: Legal Team is not a threat (and can be a savior) for social media in pharma.

Let's Make It Legal [social media in pharmaceutical industry]
Let’s Make It Legal (Photo credit: Wikipedia)
An eye opening presentation of Audrey Hagege, a Legal Manager and Todd Kolm (@toddkolm), VP and Head of Global Digital Strategy from Sanofi showed us not only what Legal Teams think about Social Media. Even more important was how distorted is an image of legal teams in the eyes of us, digital marketers working on social media in pharma. At the end it is easy – just let your legal or compliance officer know what you are going to do. They are in the organization to help and protect, and not to stop any activities.
On the other hand, while social media in pharma is becoming more and more regulated, I had an impression that some of our colleagues are going dangerously close to the line. Ms. Müge Gizem Bıçakçı Akalın (@MGizemBA), a New Promotional Models Manager at Boehringer Ingelheim’s Turkish affiliate shared with us plans to promote a Facebook page of a feminine avatar with a name very closely resembling a brand of prescribed drug for menstrual pains. Is it already promotion and communication DTC, or still just a disease awareness campaign? Let’s hope Gizem has very good friends in her legal team and they are crystal clear about their legal framework.

Social Media in Pharmaceutical Industry Key Learning #3: Social media in pharma can be measured and data driven (but not always is).

Gary Monk (@Garymonk) from Havas Lynx and John Pugh (@JohnPugh) from BI shared similar thoughts on how to measure efficiency of pharma activities in social media. As we were sitting in the UK, for obvious reasons there were not much about direct impact on sales. However, we could see important metrics on the engagement. Both speakers provided some hints on what can be improved in Facebook and Twitter presence of the analysed brands, but it is not what is the most interesting from my point of view.  
What is more important is just an attempt to step back and look at those activities and try to measure them against each other. Then track what works and what is not. How your facebook page welcomes user? How fast do you respond (do you)? How often do you tweet? Do you follow others and do you retweet or share their posts? What makes Eli Lilly or Boehringer more successful in Social Media than in the market? We can find those answers, and we should as we are no longer pioneers in the social media. It is time to treat it as a serious communication channel with real budget and real targets to meet.
The lessons on social media in pharma listed above are not a comprehensive list. I have learnt much more, and I am going to share those lessons soon on K-message in other posts. There were great examples of social media and digital in action. Mobile app helping patients to fight against depression (Claire Perrin), Catz against Asthma (Ben Furber @BenFurber), Knowledge database available online to HCPs thanks to Merck and their Univadis (Thibaud Guymard @thibaudguymard), I will not be able to mention them all now. But I can now say thank you to all participants, speakers, and SMi for making this event so inspiring. Thank you!

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Pharma Marketing

Why Pharma Marketing is Boring? Archetypes!

Pharmaceutical brands are not loved. Products of the pharma industry are saving lives every day (not to mention removing headaches of the day after). Still, an average John Doe is not grateful to the manufacturer. To be honest even if he knows the brand, he rarely likes it. Pharma is rarely connected to wellness or innovation, almost always to disease and its cost.

Why is that? The answer may be in something that pharma marketing is lacking. At K-Message we believe, that pharma brands are not understood by people. They are not understood, because they do not refer to archetypes.

12 Primary character archetypes
12 Primary character archetypes

English: Carl Gustav Jung, full-length portrai...
English: Carl Gustav Jung, full-length portrait, standing in front of building in Burghölzi, Zurich (Photo credit: Wikipedia)

According to Carl Gustav Jung, a Swiss psychiatrist,  human is not born with a clean mind or tabula rasa. Instead, we all universally share some embedded events, figures and motifs that are easily understood by anyone and that trigger unconscious reaction, similar to most if not all the people. Those universal patterns of mind are called archetypes.

Jung believed that archetypes are truly universal and not related to the culture, education or any other circumstances. While it all may sound bit odd and bit “psychic” to pharma marketers who tend to look for substantial evidence, there are some scientific research that look after archetypes in human genome (Stevens, Archetype: A natural history of Self) and locating them in the human brain (ROSSI, E. (1977), The Cerebral Hemispheres in Analytical Psychology. Journal of Analytical Psychology, 22: 32–51. doi: 10.1111/j.1465-5922.1977.032_1.x).

Regardless of the philosophical questions about human nature, archetypes are extremely useful in marketing. Whether they are embedded in the human nature or learned through socialization process, the effect is the same. Archetypes allow us to build strong, appealing and memorable stories.

The concept of brand is intended to produce unconscious emotional reaction and attitude towards it and affect conscious behavior of target audience. Jung would tell, that brand has to influence psyche to react in a certain way. Archetypes are doing just that. Therefore if you want to make your brand narration efficient, you should look for the archetypes that are connected to reactions and attitudes you want to trigger.

There are 12 main archetypal characters, from which marketer can select the one that fits the best his brand. This will allow to focus content marketing on the story that reflects brand character. There are also so called archetypal events (ie. birth, death, end of childhood, creation of the world, journey or quest) and archetypal people (mother, father, old wise man, villain) that embedded into the story will make it emotional and moving for the audience.

Pharmaceutical brands for many reasons, including regulatory, cannot promote products with more than factual stories. However it is not forbidden to build their own image in a way that makes them more human. From 12 primary archetypal characters there are eight that are reflecting exactly what most of pharma companies would like to be known for.

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8 Archetypes for Pharma Marketing

The Innocent

Is the archetype that believes in a beautiful, protected world where everybody can be happy. It is full of faith and optimism. It’s greatest fear is to be punished for doing something bad. It is an archetype that looks good for all pharma companies, as at the end they want to eradicate disease. Vaccines may be the best example here.

The Orphan

Known also as a regular guy or the everyman, the Orphan believes in equality. It also wants to connect with others and does not want to be left behind or stand out from the crowd. This makes it great archetype for any generic drug manufacturer.

The Caregiver

The Helper is an obvious choice for Healthcare Industry, it is the one who help others. This archetype who shows compassion and generosity and fears of selfishness is like created for pharma marketers.

The Explorer

The seeker looks for the freedom to explore the world. This archetype fits to disruptive companies, to those who change old rules.

The Creator

The creator is an artist who can create valuable things out of a dream. What he fears of is the failure to deliver completed masterpiece. Doesn’t it sound like pharma development?

The Sage

This is the sage, the scientist, the researcher. The Sage believes in the truth and is always looking for it. The only thing he fears is ignorance. While this archetype sometimes is not able to act, it’s wisdom makes it perfect for innovation in pharma.

The Magician

The magician, known also as the healer tries to understand the universe and make dreams come true. What he fears are adverse effects of his action, but this archetype is also very close to what pharma does with its research and application.

Which archetype reflects your pharma company the best?

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To be clear, we are not sure whether we are born with embedded stories in our guts. It is more probable, following the Ockham’s razor, that archetypes are just a way of describing something that is shaped by our historical and cultural heritage. It does not matter, as what we can observe is that archetypes indeed are embedded in the best stories of our times. From Harry Potter and the Lord of The Rings to the Wolf of Wall Street we can see the figures and events as described by Jung and his followers.

As soon as you identify the archetype that fits your brand, you do not need to really tell anyone, just brief your agency having in mind what Jung discovered. What is the story behind the Archetype Character, what is it looking for and what are the values it follows?

Pharma marketing knows real stories about the most archetypal events of human birth and death, it is all about heroic fight against disease and looking for truth that changes world. It is hard to understand why looking for examples of branding with archetypes we never see pharma. Is it because pharma marketing does not ember those “magic” patterns in their stories. Why don’t we change it right now?

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Pharma Marketing

FDA Guidance on Social Media in Pharma: We need more of this

Federal Drug Administration (FDA) has announced its draft guidance on Social Media in Pharma. What question does it answer and what remains still unregulated? What are the consequences of this guidance and expected next steps? 

English: Logo of the .
English: Logo of the FDA. (Photo credit: Wikipedia)

When finalized this guidance will regulate all Internet activities of pharmaceutical companies operating in the United States. The guidance was long expected by the pharma industry. According to earlier announcements from FDA more comprehensive guidance shall be released by July 2014.

Main proposals of the new FDA guidance for Social Media in Pharma

Pharma companies responsibility for the content published in social media:

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  1. 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.

  2. Under certain circumstances, a firm is responsible for promotion on third-party sites.

  3. A firm is responsible for the content generated by an employee or agent who is acting on behalf of the firm to promote the firm’s product.

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Pharma companies obligation to submit interactive promotional materials to FDA:

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  1. At the time of initial display, a firm should submit in its entirety all sites for which it is responsible on Form FDA 2253 or Form FDA 2301. For example, the firm should submit the comprehensive static product website with the addition of the interactive or real-time components.

  1. For third-party sites on which a firm’s participation is limited to interactive or real-time communications, a firm should submit the home page of the third-party site, along with the interactive page within the third-party site and the firm’s first communication, on Form FDA 2253 or Form FDA 2301 at the time of initial display.

  1. Once every month, a firm should submit an updated listing of all non-restricted sites for which it is responsible or in which it remains an active participant and that include interactive or real-time communications. Firms need not submit screenshots or other visual representations of the actual interactive or real-time communications with the monthly updates.

  1. However, if a site has restricted access and, as such, FDA may not have access to the site, a firm  should submit all content related to the discussion (e.g., all UGC about the topic), which may or may not include independent UGC, to adequately provide context to facilitate the review. Screenshots or other visual representations of the actual site, including the interactive or real-time communications, should be submitted monthly on Form FDA 2253 or Form FDA 2301.

  2. When submitting the site, FDA recommends that a firm take formatting factors (e.g., appearance, layout, visual impression) into consideration to enable the Agency to view the communications as a whole.

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What the industry expected to be addressed? Is it addressed with the new FDA draft guidance?

In general FDA has addressed two of five main points raised by pharmaceutical companies. Those are responsibility for the content published in the Internet and in Social Media, and 2253 Submissions requirements.

Internet control and 3rd party controlled social media responsibility

FDA has defined scope of responsibility for pharma companies. In general pharmaceutical companies are responsible for any content that they have control or influence on. Let us repeat the phrasing of the document:

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Pharma companies responsibility for the content published in social media:
1. 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.

2. Under certain circumstances, a firm is responsible for promotion on third-party sites.

3. A firm is responsible for the content generated by an employee or agent who is acting on behalf of the firm to promote the firm’s product.

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2253 Submissions

FDA requires all prescription drug labeling and advertising to be submitted at the time of initial dissemination through an FDA Form 2253. [21 C.F.R. § 314.81 (b)(3)(i)].

Until this draft guidance however, it was not clear what are companies obligations for submitting social media content. For the sake of security social media activities were limited to the safe topics and avoided mentions of any product. It may change now, as the guidance states clearly what and when should be submitted to the Agency. While industry may not be happy with the request to feed FDA with all User Generated Content that may be considered promotional, at least now everyone knows what to report.

What is left unanswered by the new FDA Guidance on Social Media in Pharma?

Space limitations and one click statement rule

FDA requires that every promotional material includes comprehensive information about the product, including safety information. Due to space limitation and “hypertexted” nature of the digital media, pharmaceutical industry developed theory of  so called “one-click rule”. The assumption was that to meet FDA’s expectation it is enough to provide on the interactive promotional material a link to the website that would include required information.

This has been questioned by the Agency which issued enforcement letters to 14 companies who used Google display advertisement where risk information was available under “one-click”. In the following statements FDA declined existence of any one-click rule, but did not offer any alternative. New guidance does not refer to this aspect of the regulation. Therefore any promotional activities mentioning pharmaceutical products on platforms with limited message space ie. on Twitter are still not possible.

Off-label discussions

Another issue that is not addressed by the guidance is off-label use discussion. Promotional messages may not recommend or suggest the drug for off-label uses. Technically it means that anyone in relation to the company is not allowed to even mention any use of the drug that is not approved by FDA. Any response to such mention in social media by pharmaceutical company may be considered as suggesting and therefore promoting off-label use. As we are discussing here open communication channels available to general public, even scientifically valid and supported by pending trials question about any product use that is not approved has to remain unanswered. This limitation remains in force with the new draft guidelines.

Drug Safety and Adverse Events Reporting

Drug Safety or Pharmacovigilance is probably the most important reason why embracing social media in pharma marketing is so slow. It is extremely important (human life is at stake), and there are too many questions unanswered around it.

The first obligation is to provide possibility to report any adverse event to the public. For websites addressed to US-based audience it is usually solved by adding MedWatch icon/link, or easily available report form. In social media this is much more difficult, as there is no way to include such link in every message.

If the company engages in social media, should not it also proactively monitor this space for any possible adverse events? Companies are obliged to report any AE found within limited timeframe, but there is possibility that report is discovered long after it was posted online. It may be written in exotic language and not recognized immediately.

Another question is if the company is obliged to actively pursue any post that may be adverse event but does not include all necessary information for AER. If that would be the case the workload could be overwhelming. Another complication is when the post mentions generic name of the drug manufactured and distributed by many companies. Shall all of them contact the original poster to find out missing information?

Those questions remain unanswered with the draft guidelines.

What will happen next?

All interested parties can submit their comments to FDA within 90 days from the date of publication in the Federal Register (01/14/2014) to www.regulations.gov electronically or in written form to the addresses provided in the document. We also expect more comprehensive guidance as mandated in FDA Safety and Innovation Act (FDASIA) of 2012. Section 1121 of FDASIA orders FDA to, “issue guidance that describes FDA policy regarding the promotion, using the Internet (including social media), of medical products that are regulated by the FDA.”.

Although in his e-mail conversation with Regulatory Focus Stephen King, FDA’s spokesman maintains that the guidance released on 13 January 2014 actually meets the statutory requirements of FDASIA, FDA “plans to issue additional guidance for drug and device manufacturers related to the Internet and social media,”  Those documents, according to the same spokesman: “Issues with character space limitations, links (the appropriate use of links), and sponsor correction of misinformation about their products disseminated by third parties.” We may then wait longer than expected for full set of regulations, but at least some steps have been done and we know that there is no need to submit every tweet to FDA before publication.
Full text of the FDA guidance: Guidance for Industry Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics
Federal Register link

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