Posts Tagged 'regulatory'

Balloon animals

A quick apology to readers of this blog. I really enjoy writing here, but the past month has thrown up a number of challenges.

One of these challenges is actually finding something interesting and, importantly, new, to write about. There are so many bloggers out there that I feel I would be doing you a disservice if I wrote basically the same stuff that others have already covered.

Social media is no longer new and exciting, and in the pharmaceutical sector at least, little has changed with regards to its use, other than the fact that pharma companies know more about it than before. Especially in Europe, where regulatory guidance is a long way off; don’t get me wrong, there have been excellent examples of innovative use of social media, however all the signs show that we are ‘over the hump’ of social media hype and are now, quite rightly, looking at it as a channel to be considered and utilised in an appropriate manner as part of an integrated plan. Not so much a bursting of the social media bubble, more a slight deflation so that we can make balloon animals (to overextend my mixed metaphor for appropriate consideration and usage of social media). Essentially in 2011, it is necessary for Pharma to bring social media into the Venn diagram and start using it appropriately.

What about the rise and rise of mobile and tablet healthcare with native apps (and in my opinion this is also something that is still overhyped and not rationally used as a tactic in an integrated plan, but I expect that to continue for the moment). I think Android will play a much larger part in healthcare as a platform with some major players bringing out Android-based tablets in 2011 (with implications in terms of enterprise, cost and accessibility).

Let’s not forget the possibilities of near-field communications (NFCs), especially now that mobile handsets are starting to integrate this technology (notably Google’s upcoming Nexus S made by Samsung, which also inexplicably has no LED indicator or SD card expansion slot). This is something that will gain momentum in 2011, with possibly some good use coming of it either late in 2011 or more likely in 2012.

Now to a topic I’ve also been banging on in this blog about recently: integration, and I think actually this will be a key theme for the focus of my commentary in 2011 – integration of digital into overall healthcare strategy. We need to be savvy that digital must fit within our offerings in an integrated manner, and that we shouldn’t get overexcited about ‘the shiny’ (be it platforms or gadgets). I expect 2011 to be the year where the ‘bedding in’ of digital occurs, where we all go back from being ‘digital strategists’ to just ‘communication strategists’, because this is where the benefits for patients, HCPs and Industry lie.

I’m excited by the prospect of 2011 in digital. Happy holidays to you all.

Paul

Social media sharing for pharma

I probably don’t need to tell you that there has been buzz recently about the new FDA guidance on social media that is predicted to appear in this year Indeed, John Mack predicted that the guidance would be issued in sections, and he puts forward a theory that guidance on short-format or space-limited communications will be published first. Whether Mack is right or not, this issue will be discussed within FDA guidance, as it has a huge effect on how we currently communicate and share information about pharmaceuticals.

I’d like to examine the current situation from the social sharing widget/link point-of-view. For those who are unaware, social sharing widgets (such as ShareThis allow users to post up snippets of content from your website on to their social media space, for example share with a status update or wall post on Facebook. This will display a small snippet of information and this has implications because invariably these snippets use metadata from your site, which is not part of the content that the user reads – it’s hidden within the code for that page.

The problem? Illustrated by the widely-cited warning letter to Novartis on their use of a Facebook sharing tool. Metadata can be very short and therefore it would make creating this snippit with fair balance very difficult. So with this in mind, how are pharma companies using sharing tools on their sites? My experience when discussing this with clients is that they are not willing to risk being in breach of regulations, and the concept of social sharing tools on pharma websites, even non-promotional ones are quashed very early by regulatory departments, even if the metdata is crafted to remove any claims and can be approved in their own right.

Of course, enterprising companies are rushing to try to give pharma companies more control over their sharing options. For example, there is the Share, Send, Save widget from Intouch Solutions and the competing tool from Bridge Worldwide and ShareThis. Currently I can’t say I have seen these tools being used on pharma-backed sites at all, but at least these give options to allow users to share content with others whilst keeping more control over the information that is provided through these tools.

So the question is, will the new FDA guidance pave the way for additional social sharing tools, will there be enough guidance for Pharma to be confident about using this functionality, and will Pharma take the plunge into social sharing in a big way?

Let’s see what the guidelines say.

When is digital strategy not digital strategy?

I want to pick up a bit more on the closing remark from my DigiPharm Europe 2010 posts. If you recall, I said:

To survive in this landscape, Pharma must make inroads into developing a digital strategy – and by that I mean integrate your digital tactics into your overall strategic plan, and at the same time, generate and maintain internal buy-in by developing a corporate digital strategy that integrates digital into the fabric of your organization’s culture and operations.

Although I work on the agency side myself, this is something that I face every day – My agency is full-service, so we integrate strategy with digital as well as traditional medical communications and we employ a range of highly skilled staff to satisfy that requirement, so there can be a challenge of enlightenment with regards to the uses of digital as a means to communicate with some people internally. Its a balancing act, and there is always resistance from those who don’t see the value of these channels or those who are set in their ways, unwilling or unable to move from their comfort zones. I approach these individuals with a mix of elucidation (e.g. demystifying microblogging), training (e.g. the concept of information architecture and the process of designing and developing a web project), encouragement (setting up a LinkedIn profile is a start) and information (circulating good examples of digital communication); all mixed in with the ol’ Jacobs Charm(tm).

For Pharma, the challenge is greater, as we have to layer on the regulatory and legal aspects (not to mention the challenge made by the boundaries of geography, where regulatory jurisdiction hinders us at every step!). For Pharma marketers wanting take advantage of the rich digital opportunities out there, it can be a daunting and frustrating task. However, with a bit of perseverance and the right inclusive and encouraging approach, it is achievable even in the most conservative of companies to gain buy-in from key stakeholders.

As a strategic thinker, its important to consider digital in your corporate, franchise and brand strategy, but I want to make absolutely clear that the phrase ‘digital strategy’ is a misnomer when it comes to a communications plan. When we consider the use of digital channels or tactics, we must also remain mindful that these are tools within the communications plan to serve the strategy, and not to replace the strategy. Pharma marketers need to be very clear that using a digital tactic will achieve those strategic imperatives. We all love iPhones, gadgetry, social media, interactive games and multimedia – but we must also make sure we take a step back and think – will this suit our needs? Or will we be better off with a simple or traditional print tactic?

Still having trouble? There are loads of great agencies out there who can help. Get a recommendation, throw a stone or ask me.

DigiPharm Europe 2010 Pt 7

Here’s my final post on the #DigiPharm narrative. Part 7! Again, I am reporting on selected sessions from Day 2, ones that I found of note or interest. You can read the twitterstream for more information on the presentations not covered here.

Part 1
Part 2
Part 3
Part 4
Part 5
Part 6

Still friends
First up after lunch was John Mack of Pharma Marketing News detailing to us Europeans the new rules for new media: a funny thing happened while waiting for FDA guidance. Waiting on the FDA is ‘Waiting for Goduidance‘; apt, considering the FDA hearing was October 2009. 70 presentations at the FDA hearings came from stakeholders, and interestingly the stats show that industry service providers made a large proportion of those presentations. Mack thinks that they are ‘pushing Pharma outside of the social media envelope‘. In addition, because of the first-come first-served basis, the share of voice for patients and HCPs was much reduced from previous hearings (1997).

From a survey taken by his readership, Mack explains that Pharma parses into different categories what they are accountable for and what they are not according to the way the funds have been given/spent (grants, paid content, display ads). Interestingly, around 45% of Pharma responders said that Pharma should be accountable for the content even on sites they do not have direct control of (funded by grants). There are also mixed views on accountability with regards to correcting third-party misinformation, with 12% of Pharma suggesting that all off-label information should be corrected by Pharma and 49% of Pharma opining that no corrections should be mandated on third-party sites.

Regarding space limitations, most responders to the survey did not know if space limitation is a problem in Pharma online communication, and therein lies the challenge: how do we make 140-character messages meaningful to the patients in addition to fair and balanced? Mack focused one of his infamous ‘Mack Attacks’ on the Race With Insulin Twitter page featuring promotional Tweets from Race driver Charlie Kimball on behalf of Novo Nordisk (although a picture of the two smiling together may indicate they are still buddies – not sure where Kimball’s hands are though!). A big thing for Pharma are Adwords and search results (around 40% of US Pharma’s online spending budget says Mack), and because Google was losing the Pharma revenue, they piloted and presented a solution for prescription drugs that included a fixed warning of 60 characters, a link to more information and a fixed landing page in the headline.

So where is the draft guidance? Mack predicted that we will get guidance by the end of October, but the FDA will produce and roll out draft mini-guidance documents over time, the first of which, he predicts, will be concerning space limitations. However, he says, that hasn’t stopped Pharma diving into social media, although there have been problems around mishandling (citing sanofi-aventis’ VOICES page being assaulted by a patient who suffered permanent hair loss from the chemotherapy Taxotere, resulting in the comments being turned off). He concludes by suggesting that the greatest mistake for an online pharma initiative is to not have a crisis plan.

Following the presentation, Mack sat down for a panel debate with Chandler Chicco’s Sam Walmsey, taking questions from the floor. Walmsey asks why he is so critical of the industry, and he admits that he “…doesn’t make a living by telling people what they are doing well, he leaves that up to awards ceremonies (it’s a dirty job but someone has to do it?). But do ‘Mack Attacks’ help Pharma? Responses from the floor suggest that they do, but it does involve a headache of lawyers (I believe that is the collective noun), Gary Monk recalls individuals who received a Mack Attack and this significantly increased their Twitter following.

The right measurement
A quick note about the presentation from Preston Hennington of PR Newswire on building your brand using multimedia. I didn’t really take much away from this, but when he was talking about using free online tools to track sentiment, buzz and influencers (such as Social Mention, Twitority and Twitalyser), it rang alarm bells. I feel strongly that these free social media tools should be used with caution, especially when interpreting the results. You are better off spending some money and getting it right!

I expect in 2040 we will all have cell towers grafted on at birth
A brief mention here of the Mobile presentation from Hedwig Scheck of GSK. Frankly I found there is nothing new here (considering my avid interest in mobile), but of note some responses from the floor from questions: most of the room are thinking about launching an iPhone app, but only a handful actually have done so. Also of note is that sanofi-aventis has unveiled an iPad and iPhone app glucometer with add-on hardware and GSK have developed an iPhone app for the German market to help allergy patients. She predicts that by 2011, more than half of brands are expected to use between 5 and 25% of their marketing budget for mobile marketing. My thoughts are that Pharma should be careful of focussing too hard on iPhone specifically to the detriment of Android – consider that Gartner predict by the end of the year it will become the number 2 mobile operating system (after Symbian and above BlackBerry and Apple). There are, of course costs associated with Android, considering the breadth of handsets and the fragmentation of the operating system. We should also be mindful of the new operating systems due: Windows Mobile 7, MeeGo (Nokia’s new smartphone OS) and Bada (Samsung), plus the launch of a number of app stores.

Microchips and pills
Next up is connecting patients and physicians to treatment outcomes in the digital era presented by Todd Stephens of Merck Serono. He starts by asking: ‘Which of these three can you do well?

  • Product leadership
  • Operational excellence
  • Or customer intimacy?’

It is difficult to move focus from one to the other, or indeed to get a balance. He says the problem currently is that Pharma needs to choose the technology they invest in three to four years in advance. There is a displacement in timelines between technology development, application of that technology, legal and regulations and roll out. Indeed, the choice of technology is relatively redundant to payors, as they are focused on outcomes, not technology: ‘Drugs are not reimbursed if they are not proven to improve treatment outcomes‘ A question: will we be looking for reimbursement of medical apps? Interestingly, Stephens implies that Merck Serono are working on a mobile compliance tool in endocrinology.

So will adherence/compliance be the next important topic in digital? I say this is one part of the patient story. With the rise of mobile help or hinder this? Will Mobile compliance apps be the way forward or, as Stephens alluded to, will ‘intelligent medicines’ as being trialled by the NHS be the way forward? More questions to debate.

The end? Not by a long run
Here endeth the narrative from DigiPharm Europe 2010, but looking back at the presentations, data, case studies, demonstrations and discussions, I can’t help but think that these are challenging and exciting times in the Pharma industry. I for one am encouraged by the growing effective use of digital technology and channels, and at the same time worried about the potential direction this could take. I think two things have become very clear from this conference:

  • There should be some discussion and agreement on regulatory issues with regards to digital and to social media in particular, and this discussion should focus on the global nature of the internet and therefore consider the cross-boundary nature of how the drug industry should be regulated.
  • To survive in this landscape, Pharma must make inroads into developing a digital strategy – and by that I mean integrate your digital tactics into your overall strategic plan, and at the same time, generate and maintain internal buy-in by developing a corporate digital strategy that integrates digital into the fabric of your organization’s culture and operations.

Thanks for reading!

DigiPharm Europe 2010 Pt 6

So here’s the penultimate part of this week-long series. Today I am focusing on the morning session of Day 2 of DigiPharm 2010 and the concluding blog post tomorrow will cover the afternoon session. I will not cover every presentation from Day 2, just the ones that had impact with the audience.

Part 1
Part 2
Part 3
Part 4
Part 5
Part 7

One-way Code
First up on day 2 was Heather Simmonds from the Prescription Medicines Code of Practice Authority (PMCPA), who is responsible for administering The Association of the British Pharmaceutical Industry’s (ABPI) Code of Practice. Simmonds stressed how important it is to follow the code of practice, even if may seem out of date (2008 was the last update). She quips ‘”Heather said it was OK” does not trump the ABPI code of practice!’.

Her advice is that ‘if you put your head above parapet, consider how you will defend what you’re doing if you have to – if a complaint is made‘. She also says that even if embarking on an educational campaign, Pharma should treat everything as promotional unless you can clearly show that it isn’t and that many EU States consider every piece of information from Pharma to be classed as advertising. I’ve often experienced this from a medical education standpoint when providing educational materials for a launch product – the materials were treated and scrutinized exactly the same way as a promotional detail aid and a journal advertisement.

With reference to the relevance of codes of practice to digital and social media, Simmonds states that in the EU, self-regulated Pharma codes of practice are media-agnostic. The ABPI Code has planned updates in November, but will be limited in scope (requirement to provide unsubscribe link in emails). She says that they know Pharma wants to use social media, but are not clear about what that use would be. The ABPI plan to first issue ‘guidance’ on social media before introducing it into the Code.

Simmonds covers the traumatic journey of the proposed EU Directive amending legislation about Pharma providing information to the general public about prescription medicines. She says that the aim is to avoid changes allowing the direct to consumer advertising that is common practice in the US. the drugs industry want to be able to provide information directly to patients, but don’t want to advertise to them.

With regards to the reach of the ABPI, if a UK company posts promotional information on the internet outside of the UK, it still falls under the remit of the code. The main questions in the UK from the PMCPA are:

  • Why do you think that social media is not covered in the 2008 code (even though it is not explicitly mentioned)?
  • What do Pharma actually want to do?
  • What will be the impact of the EU directive on providing information to patients?

Discussions on Twitter surround the fact that social media is a global phenomenon and that regional regulatory bodies need to consider this if they are to grow and adapt alongside these channels. They should possibly look at other globally-regulated industries to see how they achieve their goals in this space. There are call for a public forum to discuss these issues and the redesign of medicine regulations globally.

Comments are on
A change in topic to engaging with patients sees Gary Monk of Janssen on the stage: from innovation to integration – ‘engaging with connected patients and HCPs’. Gary talks us through a successful patient social media project using a YouTube video on ADHD that was part of an integrated approach. Monk mentions that there were practical challenges for internal agreement that included engagement and education. He says he used a YouTube video to sell the project internally (I couldn’t find it from searching YouTube, unless it’s this…?). Janssen seeded the campaign to targeted groups (parents and teachers), and the level of engagement was good.

A key point made by Monk was that the success of the programme rested not only on seeding the content well, but finding an agreement internally regarding the comment policy. In fact, it was evident that allowing moderated comments yielded more effective results than that of Pharma marketing messages. He commented that the public discussion in the comments area balanced out naturally, even the difficult discussions. Examples of comments that were not published included those that were off topic, with strong language or turn of phrase or if they mentioned specific products. With regards to the process, moderation took longer in the beginning, but became easier.

eMarketing excellence
Rene Neubach of Pfizer on how to successfully launch online programmes and engage with HCPs. He says that it is crucial for Pharma eMarketing teams to have internal guidelines for individual channels and that these guidelines should be working and evolving documents. The devil is in details: concentrate on what we know we can do well: delivering information to customers (I read this to say that obviously this isn’t the whole story, deliver info first, engage when ready). He mentioned that a website bounce rate benchmark is normal if 30-35% and that Pharma needs to get digital basics better, such as usability, language and relevance; as well as KPIs on the likes of bounce rate. He warns that Pharma can’t use literal translation of materials for multi-country initiatives: transliteration needs to understand the intent/topic and therefore this should be carefully considered (As Global, ask affiliates to manage the translation for their company).

Neubach presents Pfizer Engage, a system that allows for continued engagement with HCPs post-conference. Essentially, they use iPads during the conference and sign HCPs up to receive the enduring content. In this way, they build on the time, effort and expense of the conference, maximising the return. Pfizer measure success using an engagement index, and the programme works as it is scientific, unbranded and personalized to each HCP, although they are learning and improving constantly.

He goes on to present experience with Back in play, a patient campaign educating around the symptoms of ankylosing spondylitis that uses football (soccer) as a ‘hook’ to drive the messaging. Neubach stresses that the concept was tested with the target audience first, and it has become a great success (2 million players in a very short time).

Finally Neubach talks about integrating the emarketing team (like a centre of excellence), so that all the knowledge is collected in one global place – this avoids the problem if a brand manager leaves, carrying all the local knowledge with him. A challenge with that, as pointed out by John Mack, is that this may encourage ‘edumbness‘ in the local teams, but Neubach states that the central eMarketing team at Pfizer act like an internal agency and are very quick to respond to requests.

That cover’s today, tune in tomorrow when I start with John Mack’s Hawaiian-shirtless presentation on the process leading up to the imminent FDA guidance.


About me

Hi, my name is Paul Jacobs and I write the Medigital blog, as well as being the Director, Digital Strategy at Sonic Boom, a digital and social agency. I hope you enjoy reading my thoughts about the digital domain in pharma and medical communications/education.
Please note that opinions expressed in this blog are my very own and do not necessarily reflect those my employer, family or pets. Twitter: @PJ_Medigital
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