Sunset on the ROI of Social Media and Pharma Discussion

While many pharma companies have developed a wide and deep footprint in social media, many others have not.  When exploring the issue of whether or not to involve a brand, there are several questions to consider.  Some are very important considerations – for example – what is your communications goal and will social media help you achieve it?  And another perennial question is – what of the return on investment?  What is to be gained for a pharma brand by being involved in social media?

For those who face those discussions, here are a few considerations that I think might indicate that the days of having the ROI discussion are essentially over.

  1. Participatory Media is Here to Stay – Some considering whether or not to engage in social media will wonder – even still – if social media is here to stay. Whether or not the individual social media platforms that are popular today – Facebook, Twitter, YouTube, continue in their current form or maintain their levels of popularity – they stand for something bigger.  Social media is representative of a seismic shift in the way we communicate.  Just as television fundamentally changed the way we communicate by bringing the camera into the equation and eclipsing the spoken word of broadcast radio, social media ushered in an era of participation in communications and the balance of power between the communicator and audience shifted forever in favor of the audience.  We, the audience, can now take your message, comment on it and pass it along in the public discourse of things.  We now participate in communications and we are not likely to give that up.
  2. Social Media is Bigger than Patient Engagement – Many will wonder what value there really is in engaging with patients, their communities and their advocates.  It is doctors, after all, who write the prescriptions.  But, for many categories of drugs, it is the patients who ask for them.  Granted, in areas of medicine that involve high expertise a patient may rely more heavily on their physician.  But for a large range of medications, the patient will engage in conversation with the doctor, make suggestions or even demands for specific medications.  Beyond that, today’s media environment includes journalists – many key ones in the pharma space – who are heavily involved in social media on a daily basis and who have large followings.  Mainstream media has migrated to digital media in general and to social media in particular.  And so have doctors, who are integrating social media into the practice of medicine more and more and for whom social media is increasingly important in medical meeting venues.
  3. Social Media is Now Installed in the Wall – What that means is that social media is no longer something that is added on to a communications set of tools.  It is like the wall socket in the wall.  It is there.  It is part of the structure.  True, whether or not you plug into it or not is up to you.  But the fact that houses are now wired for electricity kind of diminishes the power of the question – what is the return on investment for my using electricity?  Likewise, social media has become part of the fundamental communications infrastructure.  Not utilizing it is an option, but it may not be a competitive one.
  4. Everyone Has Moved OnPerhaps nothing is more symbolic of the way that communications has changed than with the uptake of the smart phone.  Remember when you used your phone to call people?  Now, your phone is probably used as a phone less often than it is used to access the Internet or to use an app to get directions, measure my bike ride or count my calories.  Your phone is an entirely different communications device than it was just a few short years ago.  It has become practically ubiquitous (though I do know people without a smart phone) and we don’t even think about the way that it allows us access to constant communications and very few of us would entertain the discussion – what is the return on investment for using my smart phone?  You just do it.

So, all that is to say that in my opinion, the question on ROI has gone the way of the question of the shape of the planet.  It may still be worth having the discussion if for no other reason than to actually get grounded in your goals and objectives.  But in fact, we have all moved on and we are not turning back.  It is probably as much good to ask what the ROI is on social media in the same way you might ask what the ROI was on your press releases, your web site, or the electronic socket in wall.  In the end, it may not be a question about the return on investment as much as the cost of not doing business.

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Weekly Roundup 4.4.14

Dumbfounded by another week packed with business travel.  It was a week that truly involved planes, trains and automobiles.  I wish I could say that it will be a while before I am once again in an airport, but it would not be so.  In any case, home today for the first time in a week, and here is a bit of what happened that was pretty newsworthy that came out while I was standing in one line or another.

  • Approval of Sublingual Allergen Extract - FDA announced approval on April 3 of a new tablet called Oralair manufactured by a French company called Stallergenes.  Oralair is a once-daily dose and indicated for the treatment of hay fever induced by grass pollens and is the first under the tongue (sublingual) extract approved in the United States.  The first dose is administered in the physician’s office and thereafter can be taken home for use.  Oralair contains a mixture of freeze-dried extracts of pollens of five different grasses, including Kentucky Blue Grass, Orchard, Perennial Rye, Sweet Vernal and Timothy.  One interesting note for those of us in the pharma communications trade – FDA’s press release came out two days after the company announced approval with its own release dated April 1 and hence the unusual language in the FDA release that was dated April 3 which stated that the agency had “recently approved Oralair”.
  • Opioid Overdose Treatment – It is an unfortunate circumstance that drugs meant to alleviate the serious pain of people suffering from disease are not only often abused, but in a way that puts a life in danger from overdose.  In fact, drug overdose deaths are not the leading cause of injury death in the United States, according to FDA, suppressing motor vehicle crashes.  This week FDA approved a new hand-held auto injector to be used in an attempt to reverse the effects of an opioid overdose treatment that can be used by families or law enforcement for emergency treatment called Evzio.  Evzio contains a single dose of naloxone that is administered by a hand held auto-injector.  This is a step forward over what had been the status quo which involved administration by syringe from trained medical personnel.  The announcement was accompanied by a statement from Commissioner Hamburg regarding FDA efforts to combat prescription drug abuse.
  • Battlefield Wound Dressing - More successful innovation emerged this week when FDA announced it would allow marketing of an expandable sponge that could be used under emergency circumstances to control bleeding for “certain types of wounds received in battle.”  FDA’s release notes that the U.S. Army says that nearly half of all combat deaths are due to bleeding out and that approximately half of those could be saved if appropriate care – presumably something to stop the bleeding – could be available.  The sponges are administered by syringe and expand into the wound and are later removed from the body.  To support the removal process, each sponge contains a marker that is visible when X-rayed.

That’s it for me this week.  I am working today to produce a few think pieces for next week so that there are some more postings outside of the Weekly Roundup – due to the really busy schedule I have had since the New Year started.  Have a wonderful weekend everyone.

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Weekly Roundup 3.28.14

You know I’m busy when I don’t even have time for the Weekly Roundup.  I have had a very heavy travel schedule and a workload that has been quite a heavy one.  And sadly, there is no letup in sight for the next few weeks.  On the bright side, we seem to be past the weekly snowstorm conditions, at least here in the Mid-Atlantic states.

Fortunately this seems to coincide with the fact that FDA is running at a particularly slow pace.  The Office of Prescription Drug Promotion (OPDP) has managed to only eek out 2 letters so far this year.  There hasn’t been a press release all week until today, and there have not been any interesting speeches or testimonies submitted for quite a while.  So while I’ve been distracted, it has come perhaps at a good time.  I will be including some of the events from the week prior given that last week, I missed the Weekly Roundup.

  • New Hemophilia B Agent with Less Frequent DosingFDA today approved the first long-acting recombinant coagulation Factor IX for use in adult Hemophilia B patients.  The product, Alprolix, was approved to help control bleeding episodes and as a prophylaxis to prevent them.  Alprolix is another in what has been a long line of orphan drug approvals recently by FDA, with Hemophilia B affecting approximately 3300 patients in the U.S.
  • Migraine Prevention Drug for Adolescents - Also today, the agency announced approval of a drug for use in the prevention of migraines in adolescents called Topamax.  First approved in 1996 to prevent seizures and then approved in 2004 for prevention of migraines in adults, it is now being authorized for adolescents.  The product will come with a MedGuide.
  • Approval for Patients with Psoriatic Arthritis - From last week, a new treatment option was approved for patients with psoriasis who develop arthritis. Treatment options until now included corticosteroids, TNF blockers and an interleukin inhibitor.  Otzela is an inhibitor of phosphodieasterase-4 (PDE-4). The release advises that patients who are on the treatment should be monitored for weight loss during use.

That’s it for me.  Hopefully soon I will have more time.

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Weekly Roundup 3.14.14

The nation is on the lookout for Spring.  And so am I.

Despite the harsh, harsh and cold winds of this week, and the redundant snowfall last week, there nevertheless appear daffodil buds above the dirt, some quite robust in appearance, as if emboldened by the lack of warm days.  They seem to cope better than I.

I have been distracted from reporting by a heavy travel and work schedule, but also FDA itself seems to be somewhat quiet.  Until the 11th, there had not been a press release since February 27 and there have been only two letters issued by the Office of Prescription Drug Promotion (OPDP) all year.  Perhaps the cold is bothering them as well.

Here is a bit of what caught my eye.

  • Pew Creates Excellent World Wide Web Timeline – That never-ending font of all things good related to knowledge and research involving the Internet – the Pew Internet Research Project – put together a most excellent timeline to mark the 25 year anniversary of the World Wide Web.  The web, which involved a whole bunch of information made foundable by the development of search and about which we wanted to talk about in via our new interconnectedness that began with email and instant messaging and went on to all forms of social media, bears some remarkable milestones, many of which were relatively recent.  A few of my favorites – 1990 – 42% of American adults have used a computer; 1996 – 77% of online users send or receive an email every few weeks; 1997 – Google registers as a domain… and there are many more gems.  Check it out here.
  • Migraine Device Approved – If you saw this, you might have been confused like I was at first.  On March 11, FDA issued a press release entitled “FDA Allows Marketing of First Medical Device to Prevent Migraine Headaches“.  Why confused?  Because it said “First” and yet I had a tremendous sense of having seen this before.  So, I consulted my new, handy, dandy data base that I made of FDA press releases and did a sort on “Approvals, Devices and Migraine” and there it was from December 2013 – “FDA Allows Marketing of First Device to Relieve Migraine Headache Pain“.  And so, mystery solved – the most recent was to prevent migraines and the earlier was to relieve.  Two different devices, two different companies, one prevent and one relieve.  One interesting thing of note here – the December 2013 announcement on the device to relieve migraine pain was also released in Spanish.  The 2014 announcement about the device to prevent migraines was only released in English.  It is a challenge to those of us trying to discern the pattern here.

That’s it for me this week.  I hope everyone has a great and trending warmer weekend.

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OPDP Issues Untitled Letter Involving Social Media

Sort of.

There is, of course, a difference between a regulatory action letter that is issued because of a social media use and a regulatory action letter that is issued the communication happens to involve a social media platform.  In the former, there is something about the unique aspect of the social media platform chosen that has caused there to be a violation. That was the case in 2010 when FDA issued a letter regarding the use of a Facebook share widget that did not convey the risk information with it.  The latter, however, involves the use of a social media platform to convey a communication that would have been a violation if it had been via social media or if it had been written on a piece of paper in a brochure.

This week FDA’s OPDP issued only the second violation letter of the year.  It was an untitled letter to a company because of the use of its Facebook page. It was not the fact that Facebook was being used, but rather the fact that there was a statement on the page that advised the reader  - if you had been diagnosed with the condition for which the drug was indicated, you should talk to your doctor about a prescription.  The mention of the indication and the drug, which has a boxed warning on the label, included no risk information about the drug.

In addition, the Facebook page failed to mention some of the limitations of the use of the drug – the boundaries of its indication.  For these reasons – failure to include risk information and omission of material facts, FDA stated that the page was violative.  FDA directed that the company cease the violation.  A response could be amending the page with the edifying information or taking the page down.  Following the link provided in the letter to the Facebook page, apparently the page was taken down.  FDA, however, provided a shot of the Facebook page with the material on it here.

It is worth noting because there is sometimes a hypersensitivity to risk involving social media that leads some to believe that any use of social media is inherently risky.  But in this case, the medium did not provide the risk.   It is not unlike videos that have been cited in violations on YouTube where risk information was not conveyed.  Like them, it was the classic case where – as FDA stated in the podcast here on Eye on FDA in April 2009 – it was the message, not the medium.

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