Mark S. Senak's Blog, page 42

Optimizing for Mobile – Do It!

Recently a research report by Manhattan Research found that only about a third of pharma web sites have been optimized for mobile use.

While I still know people who do not have a smart phone, there aren’t many of them.   In general, apps offer an important incentive for people to make the move.  This is true for patients who can use apps to track and even monitor their health.  And for many patients, mobile is the preferred and most accessible means to use the Internet.  The Pew Internet & American Life Project 2012 Mobile Health Report found that 1 in 3 consumers use their phone to access health information, nearly double the number from 2 years prior.

For physicians – smart phones can now be used to examine test results and perform a number of important functions.  One survey of physicians found that 8 in 10 doctors are now using smartphones at the office (Wolters Kluwar survey, 2013) and that was primarily for reviewing drug information.  In short, for two primary stakeholders in medicine, mobile access is of increasing importance.

That means that Web sites used by those two important stakeholders need to be optimized for mobile.  Have you ever tried to access a web site on your phone only to find that it is in such small print, that you can only read it by pinching the screen to expand it, but then you can only read a few words at a time.  You can’t navigate it.

FDA’s site is optimized for mobile.  NIH?  Not so much.  CMS?  Yes.  HHS?  Nope.

And that pretty much sums it up.  It is the same pattern for the private sector and for professional organizations.  I’m not going to name names here – you should know who you are, but I took a look at several sites that doctors and patients might want to access on their phones and what did I find?

First, while the research mentioned above looked at scores of pharma sites, I looked at the top 10 pharmaceutical companies (US sites).  What I found there was that five sites were optimized for mobile – navigable and legible, and five were not.

Then I picked 10 medical societies covering a range of diseases from oncology to diabetes to cardiovascular and more.  What I found there was of these 10 societies, only 4 had their sites optimized for mobile.

That is really surprising given that medical meetings are of such importance – attended not only by docs seeking information, but by media who are going to write about it.  One can see all of the tweets coming out of a medical meeting by attendees – well they aren’t sending those tweets out on their laptops.  They are sending them primarily from smart phones.

It seems about half of the stakeholders have figured this out.  Half appear not to have gotten around to it.  Which half are you in?

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Weekly Roundup – 12-13-13

Ho Ho Ho.  Sort of.  Gifts not yet bought, much less wrapped.  In fact, ideas for buying gifts seem not to be forthcoming.  Cards sitting in their boxes without addresses or messages written inside.  Crowded stores.  No parking.  Traffic.  It is the sort of thing that can make one feel stressed.  And then one becomes aware of the setting sun at only 5 PM and realizes that this is the season that is all about the return of light which will start ebbing our way again in just one week. And the stress dissipates.

As we wind up the year, here is how we wind up the week:

FDA Approves Generic Cymbalta - According to a press release from FDA, five companies have been approved to market generic versions of Cymbalta (duloxetine) – a serotonin and norepinephrine reuptake inhibitor (SSRI) that is indicated for major depressive disorder, among other things.  The drug label contains a boxed warning.
Agency Announces Antibiotic Plans for Farm Animals – This week FDA said it was implementing a plan that would ensure a judicious use of antibiotics in farm animals with the launch of a guidance on the issue.  Because some of the same antibiotics are used in animals as are in humans to treat infection, overuse in the animal population could result in the development of resistant strains.  To address this the agency said that it is laying out a “road map for animal pharmaceutical companies to voluntarily revise the FDA-approved use conditions on the labels of these products to remove production indications” and to bring the OTC status under veterinary oversight.  FDA is asking the companies to notify the agency of their intent to sign on this strategy within the next three months and to then begin a three-year transition process.
Final AdComm of the Year – With the conclusion of this week there is only one more Advisory Committee meeting scheduled in 2013.  On December 17, the Risk Communication Advisory Committee will meet to discuss new methods for communication risk information that is part of a Risk Evaluation and Mitigation Strategy (REMS) – a discussion that will include how sponsors and FDA can evaluate the effectiveness of REMS communications.  And speaking of year-end, it was reported this week that FDA has approved 26 new molecular entities this year.

That’s it for me this week folks.  Hope you all have a wonderful weekend.

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Abandoned Properties – Social Media and Pharma

Every so often, one sees an article about what happens to the social media identities of people who have passed away.  But what happens when a social media asset is abandoned – abandoned by a brand?

Keeping track of social media activity by pharma is not an easy task.  There are a wide array of platforms, and characterizing the activity can be a challenge.  One of the greatest of these is differentiating the social media assets held by pharma by level of activity. When one does, one discovers that there is a bit of urban blight visible on the digital media landscape.

In the database that I have put together with two of my colleagues, we track social media activity across several platforms – Twitter, Facebook, YouTube, Pinterest and Google+.   As we become aware of an asset, the property and several of its traits – purpose, number of followers, etc. all get tracked.

While many pharma communications commentators often state that pharma is social media shy – the reality is that some pharma is social media shy while other pharma is highly active – with some running multiple outlets on each platform for specific purposes or to address key geographies or topics.  However, what one also finds is that many have dipped their toe in the water and have gone away.

Here is how it looks by the numbers when just looking at pharma sponsored outlets across these social media platforms (some OTC is sprinkled in here as well):  There are 240 Twitter feeds; 123 Facebook pages; 174 YouTube channels; 52 Pinterest pages and 80 Google+ sites.  (Caveat – These are the activities of which I am aware, but there are doubtless sites not captured.)

However, when you sort based on the level of activity and confine your search to those outlets that have regular or frequent updates and thereby omitting those with only intermittent or dormant sites, the numbers are far different.  For the active pharma users we have Twitter at 140; Facebook at 72; YouTube 72; Pinterest only 18; and Google+ at 26.  That means that pharma Twitter has 58% of its feeds active (or 42% inactive – depending on if you are a glass half-empty or half full sort of person).  Facebook similarly is at 58%, while YouTube is at 41%, Pinterest at 35% and Google+ at the bottom with only 32.5% of its pharma sites being active.

In total, the database is tracking 669 different pharma social media outlets, but only 328 or 49%, are active.

That may be indicative that there has been a high level of experimentation, or a lack of coordination within some in industry respecting the efforts.

But as a matter of brand housekeeping, dormant social media sites are probably not going to listed anywhere as a best practice.  For one thing, some of these will still show up in searches – either on a general search engine or on the social media platform.  For another, people may try and succeed in providing a comment on the property if that is permitted. Or, they may think you just don’t care.

As industry figures its way around social media (and waits for FDA to attend to guidance) it might be a good idea to go back and clean out old abandoned properties.

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Risky Business – Risk Information and Promotion

In my data base of Office of Prescription Drug Promotion (OPDP) Warning and Untitled Letters issued during the years 2004-2013, one of the many fields I track is, of course, the type of violations that were incurred.

There are many, many kinds of violations, but the primary categories that were tracked include:

Risk omission or minimization
Superiority claims
Overstatement of efficacy
Unsubstantiated claim
Broadening of indication
Promotion of an unapproved use
Promotion of an unapproved compound

There is an “other” category which is a catch-all for many other types of violations such as a failure to submit form 2253, omission of a material fact, inadequate communication of an indication and others.

The data base now contains 286 letters and over 1000 violations.  The breakdown of the primary violations (n=746) seen in the bullets outlined above is as follows:

As one can readily see represented in blue, the omission or minimization of risk information is by far and away taking the lion’s share when it comes to FDA citation for violations.  And yet, ironically, it would seem to be one of the easiest with which to comply.

Where have there been hangups?  Well, a considerable number of the violations for risk are where the communication names the product, the indication and perhaps some benefits and does not list any risk information at all.  None.  Zip.  How can that be?  Well, some of them were clearly intended as reminder ads, but in fact did not qualify as such. And some may not have included the information because the vehicle was perhaps not considered promotional.  For example, two very recent letters from OPDP involved promotional communications contained in a letter – a communications vehicle that OPDP has indicated in the past is, in fact, promotional.

Others have gotten into trouble where there has been a presentation of the benefits of a product in a way so as to obviously garner attention – large font, color settings, graphics, etc, while the risk information is presented via a more austere means – black and white, small font, no graphics –  or is positioned not in close proximity to the benefits.  And, as we all know by know, the risk information cannot be incorporated by reference or be “one click” away when the communications vehicle is digital.

The presentation of risk information is always an important factor, but if a product has a boxed warning, it may be especially so.  As mentioned a few weeks ago, products with boxed warnings may be more likely to be of greater concern and greater concern may translate into the issuance of a Warning versus Untitled letter.

Once you go beyond reminder ad status, you are in.  Once in, better to be safe than sorry.

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Warning and Untitled Letters and Spoken Words

Pulling on my database on Warning and Untitled Letters over the past ten years, I had occasion to look up those violations over the past 10 years that involved the spoken word. The database profiles each letter and tracks various characteristics – from company to drug to indication to type of letter (Warning or Untitled) and many more fields.  One of the categories tracked is the communications vehicle that conveyed the message found to be in violation by the Office of Prescription Drug Promotion.

Of the now 284 letters in the database, 12 involved the use of spoken word as the communications vehicle involved in a violation.  One interesting point to note – while a number of disease areas were involved, drugs addressing mental and behavioral conditions were the subject of four (33 percent) of the letters – 2 in schizophrenia, 1 in ADHD and 1 antipsychotic.

Under what circumstances were statements made?  One might suppose that the most common means for an oral statement to result in a violation would be during a visit from a sales representative – and one would suppose correctly.  But while common, that circumstance was involved in only 6 of the letters – so perhaps it is not as common a cause as one might be inclined to think.

Three of the violations involved discussions at a booth during an exhibit at a large medical meeting.  One involved a presentation by a key opinion leader at a lunch meeting. And the final two involved media interviews.

One of those media interviews is well known to “letter watchers” and involved statements made by an investigator in broadcast interviews which resulted in the highly unusual circumstance where the letter was directed to the clinical investigator instead of the sponsor.  The second of the media interviews was quite recent and is notable because it involved the statement of the company CEO doing an interview on a broadcast show directed to investors.

The takeaway here – unlike many other communications vehicles such as a brochure for example – use of oral statements in any capacity is a vehicle where the sponsor lacks a degree of control.  You can direct what goes into print, it is more difficult to direct what someone is going to say in every circumstance.  That emphasizes the need for really thorough training and practice for spokespeople regarding the parameters of regulated speech – those at all levels – from sales rep to researcher to CEO, especially in the setting of a wide-ranging media interview.

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Weekly Roundup 11-22-13

As many of us get ready to hit the road this week to spend the holiday with friends and family during this season when we give thanks and take stock of our many blessings, I will voice one now.  Thanks to the many readers who have subscribed to Eye on FDA this past year, as well as the six years before.  I’m indeed grateful for the opportunity to make observations, relay information, provide analysis and for interchanges with folks and for the opportunity to meet so many new people.

Despite the lack of postings this week – a busy one – here is a bit of what happened in this final full work week in November:

FDA Clears “Next Generation” Gene Sequencing Devices – Four new diagnostic devices termed by FDA as “next generation” in high throughput gene sequencing were given marketing clearance by the agency this week.  According to the release, the new technology will allow physicians to take a broader look at the genetic makeup of patients.  Two of the cleared devices will be used to detect DNA changes in the cystic fibrosis transmembrane conductance regulator gene.
FDA Has Marshals Seize Dietary Supplements – The agency announced that it had directed a seizure of over $2 million worth of goods – 1500 cases of finished goods and 1200 pounds of in-process/raw material good – because the products contained DMAA.  In 2012, FDA issued warning letters to companies to notify them that any products containing DMAA, which is not a legal component of supplements, had to be taken off the market.
Compounding Bill Passes Senate - By a voice vote this week, the Senate passed legislation passed by the House of Representatives in September that would give FDA additional authorities to regulate the pharmacies engaged in compounding.  The Drug Quality and Security Act will require facilities engaged in compounding to report what drugs are being compounded and to submit adverse event reports and subjects the facilities to a risk-based inspection schedule, among other things.  This milestone is added to the FDA and Compounding tab on the Eye on FDA website.
Advisory Committee is No More – FDA served notice this week in the Federal Register that the Veterinary Medicine Advisory Committee was terminated as of September 24, 2013.  No explanation was provided in the notice other than to say that the committee had been formed to review the safety and efficacy data for new animal drugs, feed and devices.

Be well.  Be safe.  For those in the U.S. – have a wonderful Thanksgiving.  See you next week.

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Weekly Roundup – 11-15-13

Many people this week are disappointed, chagrined even, to realize that Thanksgiving is not next week. Well, if not many, then me. Seriously, it is very late this year….and it is my favorite holiday.  Still, I am somewhat grateful for the extra week to complete the menus, iron all the table linens and have the house so clean that you would think I was putting it up for sale.

And so we had a full week this week and a full week next. Here is a bit of what happened in this:

New Approval for Rare Cancer – Imbruvica, a new treatment for patients with a rare type of cancer called mantle cell lymphoma (MCL) was the second treatment to be approved with breakthrough therapy designation, FDA announced this week.  MCL represents approximately 6 percent of the cases of non-Hodgkin lympohma and by time it is diagnosed, it has often spread to other parts of the body.  Imbruvica inhibits the enzyme needed by the cancer to multiply and spread and is the third drug approved to treat MCL and is intended for use after patients have received at least one prior therapy.
Device Approval for Treatment of Epilepsy – FDA announced approval of a device that is intended to be used to help reduce the frequency of seizures in epilepsy patients who have not responded well to medications.  The device is a small neurostimulator which is implanted under the scalp which detects abnormal electrical brain activity and responds with electrical stimulation.  FDA noted that epilepsy is the third most common neurological condition after strokes and Alzheimer’s and 40 percent of patients continue to have seizures despite treatment.
FDA Announces Recall of Dietary Supplement Products - People have often asked me if FDA ever issues a press release on a weekend.  Here, my friends, is evidence.  When there is a public health issue at stake, it would seem the FDA press office is ready, willing and able to send out a release.  In this case, it was Sunday, November 10 and the release was about the recall of OxyElite Pro dietary supplements that were linked to liver illness that was quite serious in nature.

That’s all for me this week.  Even though next week is apparently NOT Thanksgiving, I hope you have wonderful, restful, happy and safe weekends.

Photo courtesy of Anne Becker.

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Warning Letters and Boxed Warnings

My data base on warning and untitled letters now includes the years 2004-today.  It includes 282 letters covering a neat total of 1000 different violations.  When I was working on it earlier, I did a post looking at letters aimed at products with boxed warnings and thought it a good time to revisit the topic now that there is more information in the data base.

Common sense might tell one that if a product has a boxed warning – and therefore there are specific safety issues that FDA wants to highlight, then regulatory action letters from the Office of Prescription Drug Promotion (OPDP) might more often come in the more serious form – Warning Letters – as opposed to Untitled Letters (a/k/a Notice of Violation).  It appeared true in 2012.

What is the ratio of Warning versus Untitled Letters?  Of the 282 letters, 34 percent (96) were Warning Letters between 2004 and the present.  And of the 282 letters, only 14 percent (40) involved a product with with a Boxed Warning while 86 percent (242) did not have Boxed Warnings.  However, of the 40 Boxed Warning Letters, 45 percent of them were Warning Letters while of the 242 regular labels, only 32 percent were Warning Letters.

Therefore it stands to reason that when you are dealing with a product with a Boxed Warning in its label, extra care needs to be taken with regard to communications because if there is a violation, it would appear that there is a greater tendency for it to be in the form of a more serious Warning Letter than Untitled Letter.

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Weekly Roundup – 11-8-13

Oh dear.  I originally dated this Weekly Roundup as being in 2011.  That is the kind of week it has been – I’m not even sure what year it is.  The time of year, however, is obvious, with multi-tinted leaves fluttering in sunlight, shorter days, and cooler temperatures and we all are thinking about Thanksgiving recipes.  Well, I am, anyway, even if in 2011.

Meanwhile, here is a bit of what happened this week:

Trans Fats Action by FDA – FDA announced yesterday that it was taking action in relation to foods containing Trans Fats.  Noting that if industrially produced trans fat were eliminated from foots, it might be possible to prevent 20,000 heart attacks and 7000 heart-related deaths each year, FDA announced its “preliminary determination” that partially hydrogenated oils (PHOs) are no longer to be considered”generally recognized as safe” for use in foods.  The agency said that it opened up a 60-day comment period to collect input regarding the GRAS status pre-determination.  Over the past few decades, consumption of PHOs has diminished considerably, it still exists in many prepared foods.  If, ultimately, it is determined that PHOs should no longer be used in foods, FDA said that it will give a timeline for industry to comply.  The agency issued a press release on the topic as well as a blog posting on its blog FDA Voice.  The agency also took the unusual step of sending out an email to a list asking that the information be tweeted, however, by that time, the news had already saturated Twitter.
New Guidance on Devices - FDA announced availability of a new guidance entitled “Design Considerations for Pivotal Clinical Investigations for Medical Devices” which is meant to offer guidance for the design of clinical studies intended to support new premarket submissions.  It describes different study design principles for medical device studies.
FDA Seeking Comment on New Generic Rule on Information Updates – FDA announced today that it would be seeking public comment on a rule that would allow generic drug makers to use the same process as brand drug manufacturers to update safety information in the product labeling.  ”Under the proposal, generic drug manufacturers would be able to independently update product labeling (also called prescribing information or package inserts) with newly-acquired safety information before the FDA’s review of the change, in the same way brand drug manufacturers do today.”  In addition, generic manufacturers would have to inform the brand name manufacturer about the change.  Full information and background is available in the Federal Register posting on the topic.

That’s it for me this week folks.  Have a wonderful and restful weekend.

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The Great Digital Divide

I just got the new iPhone.  As I retired my old one, it went into a drawer with several smart phone predecessors.  I also enjoy my iPod touch and my iPad is always within reach – always.

However, my brother-in-law is one of three people I know who still has a dumb phone. A cousin I am fond of has neither an email address nor a computer.

In the morning, I step on my scale which is hooked up to the house WiFi and my weight is then fed to my iPad.  On my iPad, I can take my blood pressure by inserting a cuff to the iPad and my weight and blood pressure are put onto a chart which can be sent for download by my doctor.

But my doctor actually takes my iPad and hand writes the figures in his illegible scrawl into my chart.  There is no ability to electronically interface the information I collect with the information that is kept by my physician.

Then looking at the medical products industry – in the database where we track social media outlets which includes pharma and device companies, there are some companies that have social media assets represented in each major platform – Twitter, Facebook, YouTube, Google+ and even Pinterest.  Some companies have employee recruitment efforts on each platform.  And there are companies with multiple assets within each platform.  For example, we have 240 Twitter feeds that we track, but those represent only 60 different companies (including device companies) many of which have multiple Twitter feeds.

On the other hand, there are many companies with no social media assets at all, limiting themselves to Web sites.

Doubtless, there are many companies providing apps to support patients and doctors, and many which are not – just as there are many doctors and patients who would use them – and many who would not.

In short, the spectrum of health care communications has become not only diverse, it is in many respects, somewhat polarized.  As evidenced by the great work of the Pew Internet & American Life Project research that continually feeds us valuable information on trends in the consumption of health care information online.  There are many online physician communities and many docs using electronic medical records, and many who are not.  And social media assets for patients about and are even curated by sites such as Webicina.com which provide resources categorized by condition for both patients and doctors.

The consequence?  There are many – but here are only a few:

First, for communicators in health care, it spells the need to consider how diverse and complex a truly integrated communications effort must be to address the spectrum of both physician and patient digital users and non-users;
Second, while we get access to good, solid research on users, it is important to know as much as we can about non-users as well;
Third, for companies that are non-users, how do patient relations compare to those who have heavily invested in being digital literati?

Just a little food for thought as we become an increasingly diverse, and sometimes mis-matched, group of patients, providers and manufacturers.

(Disclosure – I am a member of the Webicina Advisory Board.)

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