It is an interesting development from a number of angles.  The website marketing of the product bills it as “breathable energy” and it is used when you open up the tube and pull in some caffeine into your mouth to dissolve there, providing you with an energy boost that the website says is equivalent to a cup of coffee without the calories and without filling you up.  You put the caffeine in your mouth where it is dissolved, but it is billed as “breathable energy”.

That differentiates it from an energy drink, or from coffee itself, which might be filling and might have calories.

It will be interesting to watch FDA approach this new category of “breathable foods” – how is it different from an energy drink, if at all, when it is being administered via a powder on the tongue?  The entire examination may end up raising more questions than in having more answers.

Stay tuned and let’s discuss soon over a cup of coffee!

First let’s look at the enforcement pattern compared to previous years.  The chart below plots out the number of letters issued each year since 1997.  While enforcement began to creep back up slowly in 2009 and 2010, it appears to have fallen off again.

Moving on to the letters of the fourth quarter themselves… During the first three quarters of the year, OPDP had issued only 21 letters. During the final quarter of 2011, they sent 9 more that covered 24 different cited violations;

• Minimization/omission of risk information – 9
• Unsubstantiated Superiority Claim – 4
• Overstatement of Efficacy -4
• Unsubstantiated Claims – 2
• Omission of Material Facts – 1
• Misleading Claim – 1
• Inadequate Presentation of Established Name – 1
• Inadequate Statement of Indication -1
• Promotion of Unapproved Use -1

The communications vehicles involved included 2 Websites, a rebate card, an exhibit panel, and exhibit booth, 2 sell sheets and oral statements.

While each violation cannot be reviewed, here are a few of the more interesting:

• The statement that a treatment provided “most relief” was deemed to be a unsubstantiated supriority claim;
• The phrase “simple, hassle-free use” became an unsubstantiated claim when the PI described a thirteen-step procedure;
• A booth display that had the indication information on top and the risk information on bottom where it was obscured by bags, boxes and materials was deemed a de facto  omission of risk information.

There were many more, but the risk information issues have always been the most prevalent violation cited in regulatory action letters. As to the number, even with the surge of the last quarter, there is still a decline from the previous year.  There had been some thought that when policy was changed in 2009 that no longer required review by legal counsel of most action letters, that there would be an increase in the level of enforcement, but that does not appear to be the case.

Meanwhile, in 2012, FDA’s OPDP has issued its first letter of the year.

Another snowless week, even when snow was predicted leads one to speculate that the daffodils, pushing their heads up so early, might not bloom just in time to have their heads poking up in a freakishly late blizzard.

Meanwhile Valentine’s Day beckons.  Good luck to all you sweethearts or sweetheart wannabes.

And here is a bit of note to be aware of from our corner of the world this week:

• FDA Issues Draft Guidance on Biosimilar Development – For a long time, the United States has been trying to figure out how it wants to oversee the development of biosimilars and it has been a slow pathway, but a milestone was reached this week when FDA issued three new draft guidances involving critical areas in the development of biosimilars.  These were “Scientific Considerations in Demonstrating Biosimilarity to a Reference Product“, “Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product“, and finally one entitled “Biosimilars:  Questions and Answers Regarding Implementation of the Biologic Price Competition and Innovation Act of 2009“.
• FDA Testimony on Biosimilars and on Drug Shortages – Yesterday CDER Director Dr. Janet Woodcock delivered testimony before the Subcommittee on Health of the Energy and Commerce Committee in the House.  She outlined generic drug and biosimilar user fees.  She then discussed the steps FDA has taken on the drug shortage issue that included, among other things, doubling the number of staff in the Center to assist in coordination and response and working with the Department of Justice regarding issues related to stockpiling.
• Social Media Week – It’s Happening – Social Media Week is happening this next week and will include Washington, D.C. this year and it is including health care in the line up of topics and activities.  The dates are February 13-17 and if you are interested in attending any of the events occurring in cities all over, check it out.  I think I may be participating in one virtually that is happening in New York.
• Draft Guidance on Unsolicited Requests for Off-Label Use – Hey – remember that draft guidance the agency issued over Christmas break (and did not issue a press release about) that many said was a partial draft guidance about social media, but in fact was a draft guidance about something entirely different that just happens to mention social media?  It was entitled “Responding to Unsolicited Requests for Off-Label Information About Prescription Drug Products and Medical Devices.”  Yeah, that one.  Well anyway, the comment period for that is still open, but I would imagine will be closing soon, so if you have a comment about it, here is the spot to do it!  Comments are due by March 29.

That’s it for me this week.  Have a good weekend everyone.

Yesterday NIH launched “NIH Clinical Trials Research and You” which takes some steps to answer some of the many questions patients might have about clinical trial participation.

Essentially the information is categorized neatly on the landing page of the site.  There is one bucket entitled “Why Should I Participate in a Clinical Trial? that leads through a myriad of text and FAQs. Then there is another one called “The Basics” that is also extremely text heavy with more questions.  Taking them in clockwise order, the next category of information is called “Finding a Clinical Trial” that is mercifully short on text but has explanation and links to searching.  The next is a small section called “Researcher Stories“that contains two videos – one an interview with a researcher about why she does research.  Finally, in the last box is “Volunteer Stories” which a collection of several videos of patients who volunteered for studies in many different conditions and diseases.

The page shows up on the first page of search when you use the terms “NIH” and “clinical trials”, which is important, but was lower than other NIH clinical trials resources, of which there are many and some of which are difficult to distinguish.  It did not show up on the first page of search, however, when just entering the terms “Clinical Trial Participation” though other NIH clinical trial information sites did.  For this reason, it is important that the other NIH clinical trial information sites offer a link back to this site for patients.

The information on the new site is thorough though a few of the information buckets could stand to be less text heavy.  Some video that addresses some of the text would be handy as would some podcasts that contain explanations of the written materials.

A big step in making this site useful will be its linkage to other sites that are regularly accessed by patients.  While the information on this site is good, and there are new videos that can be shared through social media, this is still a static Web site.  For that reason, NIH may want to consider developing an NIH Clinical Trials and You Facebook page as well.

There is a sidebar that offers promotional materials, but they are all in the form of posters, flyers and slides – nothing digital.  A widget that would send people back to this site and that would carry news of updated material might have been a good idea.

Overall, the new NIH site is a good and welcome step.  Over time, one hopes that it will also include more digital strategy behind it.

Another week has zoomed by and we have already entered the second month of 2012 and yet in my head, it is still really the 1990s.  Really.

But for those of you who are in real time, it was an interesting week and here is a bit of what happened:

• FDA Approves Treatment for Cystic Fibrosis (CF) – One doesn’t often see the word “breakthrough” used in serious circles, but the FDA used it this week in the subtitle of the agency’s press release announcing the approval of Vertex Pharmaceutical’s Kalydeco.  CF affects about 30,000 people in the U.S. and about 4 percent of them are people with a particular mutation known as G551D for which this treatment is effective.  FDA reviewed and approved the application in just 3 months under priority review, and was approved ahead of the PDUFA date.
• Komen Withdraws Planned Parenthood Support – Two women’s health giants were in the news this week as on withdrew support from another.  Susan G. Komen announced this week that it was withdrawing support from Planned Parenthood, igniting a firestorm of criticism and commentary.  While not commenting on the issue itself, it provides an interesting case study on the role of social media in crisis communications demonstrating how quickly the flames of action and reaction can ignite on a grand scale.  Today, the Komen blog stated “We will continue to fund existing grants, including those of Planned Parenthood, and preserve their eligibility to apply for future grants…”
• FDA Sued for Allegedly Reading Employee Emails – And speaking of crisis, employees who are said to have been involved in questioning the agency’s approval of some devices and notifying Congress and the Administration of same, have brought a lawsuit against the agency alleging that their personal email accounts were viewed by the agency.  This, in turn, has prompted Senator Charles Grassley to send of another letter for the FDA to read expressing strong concern, posing several questions, and providing a detailed account of the situation.  This will likely be an interesting one to watch for some time to come.

That’s it for me this week.  Enjoy the Super Bowl – if you are a fan and going to watch it or if you are like me and headed to the malls to shop because it won’t be crowded….

Today Mashable carried a posting that quoted Dick Costolo, CEO of Twitter, as postulating that the election of 2012 would be the “Twitter Election“.  Even people who do not participate in Twitter will likely have seen articles regarding trends in Twitter topics on the elections as potential predictors for primary outcomes.  Recently the TweetReach blog looked at the reach of candidate mentions during a debate and suggested that it could be a predictor of outcomes.

In fact, it is often that in mainstream media Twitter trends have become news – Twitter is not just a news medium, it is also news.

Don Costolo is correct, this will be the Twitter election – but Twitter has been significantly re-shaping journalism and the news market place since 2009 and the impact of those changes reach far beyond elections.

For example, most journalists are now on Twitter.  The primary benefits for a journalist is obvious.  It increases their exposure and therefore their influence considerably.  Instead of being names behind a headline or talking heads on a screen or behind a microphone, they are now in a venue where they can interact and develop relationships.  And instead of writing just one big story that gets printed or aired daily, they can report all day long on much more granular subjects or report in a continuous stream from a live event – such as an FDA Advisory Committee meeting.

What else has changed in journalism as a result of Twitter?

Last week I noted a high profile journalist who regularly reports the pharma beat issue a #PRFail via Twitter for the lag time between an FDA approval of a new compound and the issuance of a press release.  Press releases are by no means over, but in the Twitterverse, things happen in real time.  The minute something happens, the release needs to be there and tweeted.

And consider the media list.  Today’s media list needs to include a reporter’s twitter feed, following and some way to measure influence such as a KLOUT score.  Without that information, a media list is only partial.

Other ways Twitter may change our view of the media?  Tweetreach itself is an interesting example.  One can use it to measure the reach of a hashtag during a medical conference or to assess the baseline reach of a subject before and after a campaign.  It is in these terms we need to be thinking about media today.

Think not that many reporters are on Twitter?  Think again.  In the media lists I’ve assembled lately where I’ve had this information included, I’ve also noted the date that reporters began their twitter feeds and what quickly became apparent was that in 2009, mainstream journalists, with few exceptions, migrated heavily into Twitter and began acquiring their followers.

Sometimes as change occurs, the strategic aspects of it slip by us.  Make no mistake, however, in today’s market, particularly in healthcare, a Twitter strategy is an essential component of any media strategy.

In the meantime, here is a bit of what happened this week that caught my eye:

• Consent Decree Signed with Ranbaxy – A consent decree was filed by the U.S. Department of Justice resulting an injunction against generic manufacturer Ranbaxy addressing current good manufacturing practice (CGMP) as well as data integrity issues in India and CGMP issues at its U.S. facility located in Gloversville, New York, now closed.  The company will have to achieve compliance with third party audits to confirm.  The decree creates provisions for liquidated damages, among other things.
• FDA Approves First Once Weekly Diabetes Treatment – Amylin Pharmaceuticals announced today that the FDA has approved Bydureon (extended release exenatide) as the first once weekly treatment for diabetes.  Bydureon is a glocagon-like peptide-1 (GLP-1) receptor agonist that is indicated in addition to diet and exercise to improve glycemic control in adults with Type 2 diabetes.  Bydureon uses proprietary technology from Alkermes to provide the controlled release of exenatide.  In addition to the company’s press release on the approval, there is also a link to a multi-media release complete with video.
• FDA Approves Treatment for Advanced Kidney Cancer – Pfizer’s Inlyta (axitinib) was approved this week by FDA for the treatment of advanced kidney cancer – the seventh kidney cancer drug to be approved since 2005.  According to the company release, Inlyta is indicated for use after failure of one prior systemic therapy.  Inlyta is a kinase inhibitor designed to selectively inhibit VEGF receptors 1, 2, and 3 that influence tumor grown and is an oral therapy.
• FDA Reopens Comment Period on DTC Rule Regarding Major Statements – The FDA is reopening the comment period on specific data related to a proposed rule first published in a March 29, 2010 Federal Register Notice to establish standards that would be considered in determining whether the major statement in DTC TV and radio ads regarding side effects is presented clearly.  The agency added a document to the docket entitled “Experimental Evaluation of the Impact of Distraction on Consumer Understanding of Risk and Benefit Information in DTC Prescription Drug TV Ads” for which it is seeking further comment.

That’s it for me this week folks.  I have been travelling a good deal and posting has been tough, but hopefully I’m around the next few weeks.

Photo taken by friend Anne Hainsworth and used with permission.

Each day I step on my Withings scale in my bathroom, equipped with WiFi which then sends my weight into a cloud where I can retrieve it in a chart (lately not an attractive chart) on my i-Pad.  I can attach a cuff to my i-Pad which will then also take my blood pressure on my i-Pad and plot it out along with my weight in either chart or graph form by date and available for my physician.

The problem is that my physician then hand enters the readings into my chart with a pen and paper.

Change has happened.  The number of medically related apps is prolific.  Some, the FDA has deemed as medical apps, such as my blood pressure cuff, and have provided guidance for their development, use and approval.  Others may have a medically related purpose but are not medical apps – such as a calorie counter.  I have an app that will track my bicycle ride and estimate the calories burned and even post it on the Internet.

Patients are changing.  They are accessing medical information differently, they are storing it differently and they are consuming it more voraciously.  This access to medical information and tools means that many patients are more medically conversant and knowledgeable than the patient of just five years ago.  Medical literacy is likely on the rise.

It also changes the way physician and patient communicate.  Five years ago, I never would have considered the need for email between my physician and myself, thinking it impractical.  Today, I think a physician needs to have some portal of access for the exchange of data and information.  Here are my readings – blood pressure, blood sugar, whatever… – for the week.  The medical record will reflect information not just gathered at an exam in the office, but that gathered by my apps when I am not in the office.  And when I’m diagnosed with a new condition, I fully expect either the physician or someone in his or her office to not only prescribe some medication, but to pull out an i-Pad to steer me to some good resources, including apps.  If the condition is one where there are few treatment options and I’m expected to consider a clinical trial, the i-Pad should have a clinical trials app that lets us look at what’s available together.

The use of e-tools has become so ubiquitous, many physicians may not be aware the extent to which the patient experience is being changed.

Past milestones have had an impact on the medical literacy of patients.  Direct-to-Consumer advertising is one – where patients got greater exposure and understanding of treatments.  Search engines were another – where patients could seek out information from that great data base in the ether.  But the advent of social media with access to medical app support takes the patient to a whole new level, compelling physicians to change with them – from keeping electronic records to changing the means by which they communicate.

However, at some point, you or your care partner will begin to take action.  You will likely want to learn as much as you can about your new enemy and about opportunities that might be available to you.  And one of the first places you will probably go is the Internet. What happens when you do?

As a little experiment, I entered several different disease states into the search bar.  What came up was interesting.  What didn’t come up was also interesting.

Entering the terms “breast cancer”, “prostate cancer”, “diabetes”, “HIV” and “hypertension”.  Using diabetes as an example – what came up on the first upper page of the search were (1) ads for unspecified treatments, (2) ads for meal plans, (3) ads for supplies and (4) ads for getting information about signs and symptoms.  What also came up aside from ads were a link to the NIH site for information about diabetes, a link to the American Diabetes Association and links about signs and symptoms.  If you scroll down, you get more of the same.

What didn’t appear were any resources, paid or otherwise, that link to information about clinical trials and diabetes.

Of course, a person interested in clinical trials would enter that in the search term.  But wouldn’t it also be logical for a link to clinical trials would appear along with links to organizations, diets, treatments and supplies?  If a patient were interested in supplies, wouldn’t they also put that in the search term box?

So let’s take it to the next level and put in “diabetes clinical trials”.  This time you do get some paid ads regarding diabetes clinical trials, along with ads for cancer clinical trials.  You also get an ad for NIH clinical trials.  Other than ads, what you get are two links to trials information – one at ClinicalTrials.gov and one at the Mayo Clinic.  But above them are links to information about the subject of diabetes clinical trials (such as why you should participate in them).

There is no question that search engines are equipped to find clinical trials for a person determined to find them.  But it would also appear that clinical trials are not one of the subjects to appear when one is searching for information about a particular condition.  Yet if they did appear, it might cause some to inquire further once presented with the option.

This means two things.  One, linear search has its limits and eventually we may be better served by search that more comprehensively displays our options – not unlike the apparently now defunct Google Wheel which presented various directions for a search once the term was entered.

Second, whatever the type of search mechanism, as the results above clearly demonstrate, the search engine optimization of clinical trial materials is essential.

We may be a way off from having a different search option than the current linear search, but in any case, good search engine optimization and good search engine marketing might go a long way to expanding the pool of potential patients for future clinical trials.

From time to time, I look to see what is going on with pharma and FDA in the various social media platforms – taking the temperature on Twitter or looking to see how folks are doing on YouTube.  I thought that this week for the Weekly Roundup, it might be fun to feature a few videos that caught my eye when looking over all of the pharma and FDA YouTube channels.  The industry, for the most part, has not exactly mastered YouTube, though there have been some exceptions and some bursts of creativity. Here are a few that caught my eye this week for being either innovative or interesting. Had a lot of trouble embedding them, so there are links to the videos.

• It Gets Better – As many know, there has for a while now been a campaign known as the “It Gets Better” project that speaks out to lesbian and gay youth to let them know that if they are the victims of bullying, they can get help and life will eventually get better and many different people and institutions have posted videos to send that message including government agencies and high profile celebrities.  Posted this week to YouTube, GSK joins them putting up the company’s own “It Gets Better” video featuring an entire chorus of GSK employees.  You can view it here.
• Connecting Hearts Abroad – YouTube is a wonderful way to bring home an understanding of what can be, and is being, done on the ground in the way of global development and philanthropy.  LinkTV created ViewChange.org which is a great example of bringing stories from around the world that we wouldn’t normally see about global development.   For pharma, YouTube is a great way to demonstrate that kind of philanthropy in action, but is largely under utilized.  This week Lilly put up three videos about a program called “Connecting Hearts Abroad”.  The first video introduces the program by Lilly to choose up to 200 employees to send around the world during 2011 to serve in a volunteer capacity for community development, education and in health clinics .  You can view the inaugural video here.    What would make this really great is to have the employees take videos that show the work done in-country and then put those up on this channel in their own playlist.
• Managing Chronic Disease in Rwanda – In the same vein, the Medtronic Foundation is bringing us video from an in-country effort.  They support Partners in Health which worked with the Rwandan Ministry of Health to create a model for the management of chronic disease.  This video, actually posted a month ago, overviews the project in a simple, but very effective way and you can view it here.
• Raising Disease Awareness and Having Fun – The people at the PfizerUK channel rarely disappoint.  In this video you can see a few hundred people on the street in London wearing flesh colored body suits sculpt themselves on the street into the shape of a hand to raise awareness of Dupuytren’s Disease.  Clever, short and attractive and getting a very impressive number of viewings, and you can be one of them by clicking here.

That was fun wasn’t it?  Now go forth and emulate….