Mark S. Senak's Blog, page 46

Weekly Roundup – 6-21-13

Summer began today.  This is my favorite day because it is the longest day of the year.  Of course, if you are a glass half-empty person, then you might think of this as the day when the days will start to get shorter, but I prefer to think of it as the peak light period. In case you haven’t picked up on it, I am a lover of light.  February is always tough for me.  June – not so much.

And speaking of light, here is a little to shed on what happened this week that was interesting:

First Test Approved for Genotyping Hep C – FDA announced this week the approval of the first test for identifying the genotype of the Hepatitis C virus that a patient may be carrying.   This development provides physicians with the ability to better target treatment to the specific type of virus that a person has.  ”Tests such as this one can help physicians gain an understanding of a patient’s HCV status,” said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in FDA’s Center for Devices and Radiological Health.  ”Along with other clinical factors, the particular type of HCV is an important consideration in aiding health care professionals in determining if and when to initiate treatment and the appropriate type of treatment.’
NIH Launches Dietary Supplment Label Database – This is pretty cool. NIH announced this week a new database that contains the label information for all dietary supplements that are sold in the U.S.  You can do a quick search for any ingredient, look at specific products, search by manufacturer or distributor and perform advanced searches – for example looking at health-related claims.  The release states that the database has the ingredients listed on the labels of about 17,000 products.  Also, noteworthy is that there is an app for consumers called MyDS – My Dietary Supplements – which helps you keep track of the vitamins, minerals, herbs and other products that you take.
NDAC to Consider RX-OTC Switch – While Rx to OTC switches used to be quite common, in recent years the rate of switches has slowed considerably.   It makes sense that as prescription drugs become more complex in nature, the ability to switch them becomes a bit more challenging.  And while there have been numerous unsuccessful switch attempts for statins, the inability to self monitor has been an inhibition though with the advent of so many medical apps, that may change in the future.  In any case, FDA is announcing a meeting of the Non Prescription Drugs Advisory Committee (NDAC) for July 31 to consider a switch for triamcinolone acetonide nasal spray for which the proposed use is to temporarily relieve the symptoms of hay fever or other respiratory allergies: nasal congestion, runny nose, sneezing, itchy nose in adults and children.

That’s it for me this week.  May today be the beginning of a wonderful summer for you  as well as a great weekend.

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RSS Feeds – Choice Time

Remember when you just read one thing at a time?  Those were the days huh?  One newspaper at a time, one book at a time, one blog at a time.  Then came along a way to aggregate all the stuff you want to keep tabs on and you were no longer reading one thing at a time.  You were multi-reading, which is like multi-tasking, only limited to reading.

About half of the people who subscribe to this blog do so by RSS Feed, while the other half subscribe by email.  RSS Feed subscribers will see a posting that gets published in their RSS feed reader within minutes of my hitting the Publish button.  Email subscribers will likely not see the posting until it arrives in their mailbox the next day, unless I happen to publish early in the morning, in which case they may get same day delivery.

Preferences rely, of course, on your needs in consuming news.  For me, a feed reader is my preference because I consume news from a ton of sources involved in various aspects of healthcare, particularly relating to the medical products industry.  A reader allows me to digest what is going on all day long from about 500 different sources and seize on those items which interest me.  Some of that news, I push out, in turn – either here on the blog or on my Twitter feed.  Aggregation of all the news I follow in this manner is an essential service for me.

For those of us who use Google Reader to aggregate our feeds, we learned in March of this year that Google would be pulling the plug on Google Reader as of July 1 – date nearly upon us – which necessitates a decision to either get a new reader or do without. The news of the shutdown was a sudden blow for many of us and there was a sense of helplessness as I wondered what I would do now…For some of us, this news was on the order of something like – oh guess what – they have decided not to make cars anymore…..

Digg has even got a countdown clock running to show how much time is left.  And Digg does so with a reason. They are in the process of constructing their own Reader to launch in time for that to be an option for those of us looking for a new reader.

I migrated my feeds effortlessly to my new reader.  If you have been procrastinating, perhaps it is time to get started on your search that will enable you to keep aggregating your news the way you want.  Happy Reading.

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Weekly Roundup – 6/14/13

Happy Flag Day!

It is difficult to comprehend the speed with which the year is going by – in just two weeks, 2013 will be half over.  I am kind of still in 1996 in my head… In any case, this week happened, with storms to spare, and here is a bit of what happened in our corner of the world:

There’s Got to Be a Morning After – This week FDA received approval for its plan respecting Plan B One-Step contraception to move to OTC status by the judge who ordered that restrictions to access be lifted bringing this years-long saga a step closer to some resolution.  This came after the government decided to drop its efforts to appeal the federal judge’s order to make the emergency contraception available.  The plan apparently applies only to the one dose version and not the two dose version which presumably it will become available once there is labeling and packaging for the product.
Guidance Issued on Codevelopment of Two or More Investigational Drugs for Use in Combination – As combination treatments become more common, FDA has issued a Guidance on developing such compounds.  The guidance is meant to provide insight into the codevelopment of two or more drugs that have not been previously approved.  The agency said that the guidance is intended to describe the criteria for determining with codevelopment is an appropriate option and makes recommendations about nonclinical and clinical development strategies as well as regulatory process issues, including labeling issues.
Draft Guidance on Cybersecurity of Medical Devices – Could someone hack into your pacemaker?  Apparently.  As described in a really interesting story in today’s Washington Post , researchers found it possible to gain access into multiple medical devices.  Consequently, FDA has issued a draft guidance for comment “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices” to outline issues that manufacturers might consider in preparing premarket submissions.  The agency is looking for public comment on the draft guidance over the next 90 days.
FDA Approves New Indication for Xgeva - Issuing its first press release in over two weeks, FDA announced expanded approval of Xgeva, first approved in 2010 to prevent fractures when cancer has spread to the bones,  to treat adults and some adolescents with gian cell tumor of the bone (GCTB) – a rare and usually non-cancerous tumor that generally occurs in adults between ages 20 and 40.

That’s it for me this week.  Please note that I have updated the legislative tab on the blog to include the latest proposed bills that would impact FDA and stakeholders, including newly proposed legislation regarding compounding.  Have a good weekend everyone.

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Twitter, Media and Pharma

Twitter is now over seven years old.  It is hard to believe that the emergence of a media platform that allows expressions only 140 characters long would transcended to become a major force in  media today.  Yet, as we have seen, as a media platform Twitter has mainstreamed.  There has been no shortage of events over the past few years where Twitter has not been an extremely essential means for finding out what is happening under circumstances where events are unfolding quickly on the ground.  As a result, traditional media outlets find themselves reporting news that has been picked up on Twitter.  And during a crisis situation, it tends to be Twitter where the communications plays out.  The importance of Twitter as a medium for journalism became apparent in early 2009 with the landing of a jet in the Hudson River – pictures of which went out over Twitter.

For journalists, Twitter offers more than immediacy, it offers a level of granularity that may not have been available without this medium.  For someone who puts together one story a day for print or broadcast, Twitter offers the ability to report on many, many smaller aspects of a story or many smaller stories that would never make it into the one big story.  In other words, Twitter offers a means of on-going relevance to reporting.

And of course, many companies are have embraced Twitter as an extension of their own communications efforts.  That is even true of the highly regulated pharmaceutical industry, despite the fact that there has been a long wait for regulatory guidance from FDA on the matter of social media.  Over the past year, I have been working on a continuing project that tracks and catalogs social media efforts by pharmaceutical companies.  It will always be a work in progress, adding to it social media assets as I become aware of them.  For Twitter, I am now aware of about 230 different Twitter feeds being run by about 50 or so different companies.  Those feeds have hundreds of thousands of followers and companies have cumulatively sent thousands and thousands of tweets.

As I examine different companies to see if they have a Twitter feed, I am struck not only by the number that do, but the number that do not.  Many companies have stayed away from this media platform – and indeed, all social media platforms, despite the fact that top tier healthcare and investor journalists are here. That is presumably because they either do not see the value or because they do not see the guidance and have regulatory concerns.  However an examination of the track record should add clarity.

The value is evident given (1) the nearly universal involvement of journalists in Twitter and (2) its role during a crisis. It is not, after all, an asset one can build in the midst of a crisis.  And a comparison of regulatory action letters by FDA of Twitter versus a Website (something no company would be without) yields perhaps some valuable insight.  Comparing the time period since 2006 (when Twitter came into being) – one finds that a web page or web site has been cited by FDA’s Office of Prescription Drug Promotion 42 times.  The number of instances involving Twitter – zero (0).

In the end, I think that the “ROI” on social media – particularly Twitter – like that of a web site – is not only a consideration about the value it brings a result of having it – but the value that is missed because one doesn’t.

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Weekly Roundup 6-7-13

I have been away on vacation and while I thought I would be posting while on vacay – not so much it appears – and yet lots has happened, so here is a brief attempt at catching up. While I have been rounding up views of the ocean, there has been a lot going on and here are just two of note.

Avandia Restrictions Reconsidered by AdComm – Surely the biggest news of the week is in relation a joint meeting of the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee.  The two day AdComm was announced for the purpose of discussing the readjudication of the Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemic Diabetes (RECORD).  The meeting was not without its controversy as noted in a blog posting on FDAVoice on the day before the meetings by Dr. Janet Woodcock – “Avandia: Hearing All Sides in Scientific Debate” where she stated that given the enormous effort that went into researching this drug, she felt that every effort should be made in assessing the results of the trial in question.  According to the GSK announcement on the outcome, the 26 panelist vote broke down with 13 members voting to remove any restrictions, 7 voting to modify the Risk Evaluation and Mitigation Strategy program in place, 5 voting to continue the REMS program and 1 voting to withdraw the drug from the market in the U.S.  This will not be the end of the story as FDA will now have to act on the committees’ recommendation.  While a there has been uncertainty expressed on a number of fronts throughout this process – one thing is certain – the situation certainly presents some unique communications challenges for FDA as the story continues.
Majority of Americans Now on Smart Phones – Pew reported this week that a majority of Americans now claim smart phone ownership – 56% this year compared to 46% last year and 35% the year before that.  Wait – isn’t that a technology story?  Yes it is, but it has increasing healthcare implications on a number of fronts.  The most obvious of these is the fact that as increasing numbers of people access information through mobile technologies, sites that want to provide health care information competitively have to be optimized for mobile use.  Secondly, the increasing numbers mean that the role of medical apps stands to increase in importance as more and more people access the technology that, when combined with an app, will let them perform all sorts of self-monitoring never before considered.  And finally, a third factor to consider is that mobile access enhances more frequent use of social media sites as well, meaning that the role of social media in healthcare may see a boost as well.

That’s it for me this week.  I’ll return next week with more regularly scheduled programming!  In the meantime, have a wonderful weekend.

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FDA “It Has Come to Our Attention” Letter on Medical App

There are Warning Letters, Untitled Letters, otherwise known as Notice of Violation Letters, and now there is the “It Has Come to Our Attention Letter”.  I have to admit, I had not heard of this particular kind of letter before, but one was sent this month the maker of a medical app that performed the task of urine analysis.  I did end up finding a few other examples, however, this was the only one I found that was actually had that as a title at the top –  ”It Has Come to Our Attention Letter”.

In any case, this “It Has Come to Our Attention Letter” – hereafter IHCOAL – raised the fact that FDA became aware of the existence of an app that served as a device allowing one to perform one’s own urine analysis with the assistance of a smart phone.  It apparently works by using the phone app in conjunction with re-agent strips – or dipsticks – the app reading the dipsticks to provide the analysis.

In the letter, FDA stated that while the dipsticks have been cleared for use, they have been cleared when used for a direct visual reading of the results.  In using the app to read the dipsticks, it was FDA’s position that the app along with the phone was functioning as an automated strip reader.  ”When these dipsticks are read by an automated strip reader, the dipsticks require new clearance as part of the test system.”  In that case, then FDA said there needs to be clearance for the whole new system of analysis – the app used in conjunction with the strips.

So – three lessons.

First, the days when your phone was just a phone are long gone and one can expect to see apps doing things that put more ability in the hands of patients to work without a learned intermediary.
Second, in the wake of issuing its Draft Guidance on Mobile Medical Applications, FDA has shed further light on its regulation over medical apps with this letter.
Third, there is such a thing as IHCOAL letters!

What next for my phone???

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Weekly Roundup 5-24-13

Yee Hah!  Memorial Day weekend is upon us – and not a moment too soon.  It is time for hectic Spring to ease into lazier days of Summer.  I hope.  As for me, it may seem that I have been lazy of late, but it has been quite the opposite.  It looks like it has been a busy week all around and here is a bit of what happened that I thought was interesting:

Dr. Woodcock Testifies on Drug Compounding – On May 23, Dr. Janet Woodcock, Director of the Center for Drug Evaluation and Research (CDER) provided testimony before the House Committee on Energy and Commerce Subcommittee on Health regarding Drug Compounding.  Citing the recent issue that arose related to a fungal meningitis outbreak with a compounded product that has resulted in multiple deaths and illnesses, she provided a historical overview stretching back to 1997 of several other incidents involving compounded products and also discussed additional incidents coming to light this year.  She outlined steps FDA is taking in instituting a risk-based model to identify pharmacies for priority inspections and using investigators who would normally be involved in the inspection of conventional drug manufacturers. She provided interesting details of this experience and noted that the agency is hampered by ambiguities regarding the agency’s enforcement authority in this space.  The testimony has been added to the FDA and Compounding resource tab that has been added to the Eye on FDA blog site.
FDA Approves Marketing of New Diabetes Diagnostic Test – Last week there were a number of “firsts” in the Weekly Roundup and this week we continue in that vein with the announcement by FDA that it was allowing the marketing of the fist A1c test labeled for diagnosing diabetes.  The COBAS INEGRA 800 Tina-quant HbA1cDx assay manufactured by Roche will be available for use by health care professionals.
FDA Activities Related to China - Ever been curious about what FDA does to support the safety of the global supply chain?  This week FDA provided testimony before the Congressional-Executive Commission on China on FDA’s activities related to that country.  Though country-specific, it is also quite educational about the challenges the agency faces and the enormous undertaking the task is in a time of increased globalization.

That’s it for me this week folks.  My thanks to those of you who joined me for the Webinar I held earlier this week.  I hope you all have a wonderful and relaxing long weekend.

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Weekly Roundup 5-17-13

It has been a busy May.  From working in the yard to transform it from looking like property on which Boo Radley might have a house to putting on panel discussions and layers of business travel to grading papers and posting final grades to end up this semester of teaching.  I didn’t even get time for the Weekly Roundup last week – when lots happened – so I was determined to get it out this week and here it is.  This week there were a spate of interesting approvals – so let’s round it up!  Yee Hah!

But before I do, let me remind you that I will be doing a Webinar on Tuesday, May 21 at 12 Noon Eastern Time where I will be reviewing my data base on FDA Warning and Untitled Letters and comparing enforcement respecting digital versus non-digital communications vehicles.  The Webinar is free and open and I will be going into more detail and discussing additional aspects beyond what was in my White Paper on the same topic from last month – so sign up here.

The Stamp of Approval was busy this week at FDA:

First Companion Diagnostic to Detect Gene Mutation Associated with a Certain Type of Lung Cancer Approved - FDA announced early this week the approval of the cobas EGFR Mutation test which is a companion diagnostic test to be used in conjunction with an already approved drug.  The test detects epidermal growth factor receptor (EGFR) which exist in approximately 10% of non-small cell lung cancers, the most common type of lung cancer.  This type of diagnostic will provide valuable direction in determining which patients will benefit from which treatment.
First Nimodipine Oral Solution Approved for Some Brain Hemorrhage Patients – Though approved on May 10, FDA issued a press release on May 14 about the approval of Nymalize oral solution to treat patients who have experienced a ruptured blood vessel in the brain.   Previously this medication had only been available as a liquid filled gel capsule.
Prostate Cancer Drug Approved – A new drug for those fighting advanced prostate cancer was approved by FDA this week called Xofigo (radium Ra 223 dichloride) three months ahead of the PDUFA date under a priority review.  Xofigo is intended for use in men whose cancer has spread after receiving medical or surgical therapy to lower testosterone.  It is the second prostate cancer treatment approved this year.
Simponi is Approved for Ulcertative Colitis - FDA approved Simponi (golimumab) injection to treat moderate to severe ulcerative colitis in adults with moderate to severe US that is resistant to prior treatment or which requires continuous steroid therapy.  Simponi works by blocking tumor necrosis factor (TNF).  Simponi is approved for the treatment of rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.

That’s it for me this week.  Have a good weekend everyone.  Come to the Webinar on Tuesday!

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Webinar on FDA Communications Oversight in a Digital Era

Many may recall that in early April, I released a paper I did here on Eye on FDA called “FDA Communications Oversight in a Digital Era” that examined the patterns of enforcement by FDA’s Office of Prescription Drug Promotion as expressed through warning and untitled letters during the years 2008-2012 assessing what differences may exist between traditional communications vehicles and digital properties.

The paper is based on a data base that I have compiled that characterizes warning and untitled letters from 2004 onward.  The years 2008-2012 were chosen to reflect a period of time when there was an increasing use of the Internet by people seeking healthcare information and by the ascendancy of social media platforms.

YOU’VE READ THE BOOK!  NOW SEE THE MOVIE!

Well, not quite a movie.  On Tuesday, May 21 at 12 P.M. Easter Time, I will be conducting a Webinar that overviews the findings from the White Paper and will provide some expanded comparisons of digital and social media, as well as a few other observations from the data base.  The Webinar is free and if you would like to register, you can do so here.

The data base allows a vast number of analyses having tracked multiple fields of characteristics including whether a communications vehicle was digital, what type of label the product had (boxed warning or not), the type of violations, the treatment area for the product involved and many more.

I hope you will join me on May 21.

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Weekly Roundup 5-3-13

The grass is not greener on my side, mainly because it is mostly not there.  The lawn, if you want to call it that, looks like it needs a lot of attention – probably more than I have to give it.  Still, that did not stop me from mowing what was there this week for the first time this season as the old mower really did (miraculously) start up for another year.  I am happy to say that many weeds met their end, pulled out by the root after a good, soaking rain….

It was a busy week on many friends, particularly for those of us with our eye on FDA. Here are a few of the things that I wanted to bring to your attention in case it got by you:

FDA Approves Plan B for Wider Age Range OTC – This was certainly one of the more interesting developments that transpired this week and a lot happened here. First, prior to this week, a court ordered that age restrictions for access to OTC Plan B contraceptive be removed.  Then – this week, FDA announced it was approving Plan B for use by women without a prescription if they were age 15 years or older.  Then, it was reported that the Justice Department announced that it would be appealing that court decision.  This has been a long, long saga. Obviously, it will get longer.
EMA Opens up Public Comment Period for Guideline on Biosimilars – This week EMA posted their Guideline on Similar Biological Medical Products on line to invite public comment.  The comment period opened May 2 and will run until October 31.
FDA Approves Procysbi for Rare Genetic Condition – Procysbi (cysteamine bitartrate), marketed by Raptor Pharmaceuticals, was approved this week by FDA for the treatment of nephropathic cystinosis in children and adults.  This is a rare genetic condition that only affects an estimated 500 patients in the U.S. and 3000 worldwide which causes a protein building block (cystine) to build up in every cell of the body which in turn, causes kidney problems and lead to small growth and stature, among other things.
FDA Investigating Added Caffeine – The agency announced this week that in the face of a growing trend where caffeine is being added to a wider span of food and beverage products there will be a higher level of scrutiny on the part of FDA. Caffeine was approved nearly 60 years ago for use in the manufacturing of cola beverages, but the agency says that existing rules never anticipated the current proliferation of products.  The Q&A supplied by FDA however did not provide much detail into the process the agency will be using to conduct its investigation into existing caffeine in products and what to do about it.

Speaking of caffeine, I think I’m going to take a break here.  I hope you all have a wonderful weekend and are enjoying Spring.

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