Mark S. Senak's Blog, page 45

August 2, 2013

Weekly Roundup 8-2-13


Today is the day that the Congress, specifically the House, leaves our lovely town and heads home, converting my 40 minute commute to 12 minutes.  Thanks guys!


The grass is brown.  The mosquitos are ferocious.  The weeds are back.  But it is Friday and here is a little of what happened this week:



GAO Issues Report on Compounding – This week the GAO issued a report “ Drug Compounding:  Clear Authority and More Reliable Data Needed to Strengthen FDA Oversight ” the title of which sort of says it all.  In fact, the opening few lines should be enough to frighten us all – “Two federal court decisions have resulted in differing FDA authority in different parts of the country…”   The report states that not only is there a confusion around authority that inhibits FDA from inspecting facilities, but there is a lack of information available as well.  The notice of the report has a highlights page and a podcast as well as the report available on it.  A link to the report has been added to the Eye on FDA Compounding Tab on the blog site.
Primer on the Affordable Care Act – Thanks to my buddy Kip Piper for the heads up on this.  Despite the fact that today, once again, there are members of Congress attempting a vote to repeal the Affordable Care Act, chances are it is going to be implemented and that day is not far off.  Truth is, my feeling is that most people are pretty unaware as to many of the details.  The Congressional Research has put together a nice overview that sheds some light on how the tax issues work with relation to the credits for purchasing insurance.
Legislative Update – I update on interesting bits of proposed legislation before Congress as I become aware of them and add them to the Eye on FDA Proposed Legislation Tab on the blog site.  Today I am adding H.R.1801 – Cancer Drug Coverage Parity Act which would amend ERISA to require that coverage for cancer drugs not be less in a plan than coverage for any other kind of drug.  The bill has no related bill in the Senate, but has 57 sponsors in the House.

That’s it for me this week folks.  I hope you all have a great weekend.




Share this:



Share this page via Email


Share this page via Stumble Upon


Share this page via Digg this


Share this page via Facebook


Share this page via Twitter
 •  0 comments  •  flag
Share on Twitter
Published on August 02, 2013 07:15

July 30, 2013

Is There a Doctor in the House? The Medical Background of Congress

Congress oversees a great deal that has to do with health care.  You may have heard a little about that little piece of legislation that was passed called the Affordable Care Act (a/k/a Obamacare), comprehensively reforming our system of healthcare to extend coverage to those previously unable to get insurance.  You may also be aware of Congressional oversight and the passage of occasional legislation related to the Food and Drug Administration, an agency which regulates one-fourth of the U.S. economy.


But what you might not be aware of is how many members of Congress come to the institution with a medical background.  Thanks to the recent update of Norm Ornstein of the American Enterprise Institute, Tom Mann of Brookings, Michael Malbin of the Campaign Finance Institute of Vital Statistics on Congress, we have the most up to date information that provides a historical look at many valuable aspects of Congress over time.  One item tracked was the profession of members of Congress over time.  How many of them came with a medical background?  Here is an overview that reveals that there has not only been an increase in the number of members coming from a medical profession, but that in fact it stands at the highest number over time.



If you breakdown the representation of the medical professions by party, an interesting pattern emerges.  For many years, the two parties were somewhat in parity throughout the various Congresses, but in the 103rd Congress in the early 1990s, the GOP began to outpace Democratic members quite a bit.  The chart below only provides a breakdown between the parties through the 112th using the data from Vital Statistics, however I believe after a review from a JAMA article – “Physicians in Congress”, that the breakdown in the 113th would be 18 GOP and 2 Democratic.



In any event, when you compare the number of lawyers in Congress – in 1953 there were 247 members from the legal profession while there were only 6 members from the medical profession.  By 2013, the number of members from the legal profession dropped to 156 while the number from the medical profession rose to 20.  I will leave you to draw your own conclusions.




Share this:



Share this page via Email


Share this page via Stumble Upon


Share this page via Digg this


Share this page via Facebook


Share this page via Twitter
 •  0 comments  •  flag
Share on Twitter
Published on July 30, 2013 06:31

July 26, 2013

Weekly Roundup 7-26-13


The week has brought great relief from both the heat and the humidity this week which was most welcomed.  The garden got a break as did the gardener.  Soon the Congress will all go home and the town and the traffic will subside somewhat for the last month of summer vacation.  That is good.


While we anticipate that, here are a few points of interest to observe from the past week:



FDA Seeks Public Input on Menthol Cigarettes –   The agency announced that it was issuing an Advanced Notice of Proposed Rulemaking (ANPR) to seek additional information to help the agency make informed decisions about the presence and effects of menthol in cigarettes.  The agency has issued a preliminary evaluation of the possible health effects of menthol in cigarettes and is inviting comment on that as well.  FDA is finding three menthol-related studies;  1) looks at whether genetic differences in taste perceptions explain why certain racial and ethnic populations are more likely to use menthol cigarettes; 2) to compare exposure to smoke-related toxins and carcinogens from menthol and nonmenthol cigarettes; 3) to examine the effects of menthol and nonmenthol compounds in various tobacco products  on both addiction and toxicants.  Written or electronic comments (link above) may be submitted until September 23.
Warning Letters Sent to 15 Companies Marketing Diabetes TreatmentsFDA this week took action against 15 companies that it said were marketing treatments for diabetes, some labeled as supplements, advising consumers not to use these particular products or those deemed similar.  The letters were sent to companies marketing the products both online and in retail stores.  The release from the agency said that many of the company promotions for these products stated that they could “prevent diabetes” and “can replace medicine in the treatment of diabetes”.  Some of the products, FDA said, contained undeclared active drugs.
FDA Allows Marketing of New TB Test - A first for the U.S., FDA announced that it will permit the marketing of a test that is being labeled for the simultaneous detection of TB bacteria as well as for resistance to the antibiotic rifampin.   The release stated that the test – called Xpert MTB/RIF Assay – is less copmlex to perform than other previous tests for detecting TB bacteria and results are available in approximately two hours.
FDA MedWatch Alert Regarding Ketoconazole – While I don’t usually carry much news about MedWatch alerts, this one struck me only because of the length of time that ketoconazole has been in use.  Back in my days of work in HIV/AIDS in the early 1980s, I recall its widespread use for people with AIDS in the treatment of oral candidiasis (a/k/a thrush).  Today FDA issued a MedWatch alert announcing several actions related to ketoconazole warning that there is a possibility of severe liver injuries and adrenal gland problems and that there is a potential for harmful drug interactions.  The actions include a label change and revised MedGuide.
Two New Proposed Rules from FDA Regarding Imported Food – A public comment period was opened regarding two new proposed rules under the Food Safety Modernization Act (FSMA).  Importers would b e held accountable for verifying that their foreign suppliers are implementing prevention-oriented food safety practices, achieving the same level of safety as domestic growers and processors.  In addition, the rules aim to strengthen the quality of foreign food safety audits.  Comments can be made until September 16, 2013 though the agency states in the release that it intents to grant a 60-day final extension.

That’s it for me this week.  I hope everyone has a wonderful weekend.




Share this:



Share this page via Email


Share this page via Stumble Upon


Share this page via Digg this


Share this page via Facebook


Share this page via Twitter
 •  0 comments  •  flag
Share on Twitter
Published on July 26, 2013 08:39

July 25, 2013

Can Technology Usher in New Era of OTCs?

As many long time readers know from earlier postings about this topic, when I step on my bathroom scale, it records my weight and sends it to my iPad.  I have a blood pressure cuff that hooks up that very same iPad and takes my pressure and the two figures are then put into a chart which I can share electronically with my physician.  With the advent of the smart phone, self-monitoring has taken on new dimensions.


Activity trackers are hitting the shelves like crazy, with some even recording your heartbeat.  I now have added to my collection a wrist band that monitors the quality of my sleep – recording how many times I wake up each night and how much of my sleep is spent in “deep sleep” as opposed to “light sleep”.


Today mobilhealthnews reports on research into non-invasive sensors that are becoming increasingly sophisticated – (“Wearables to move beyond activity, vital signs to biosensors“).


As noted here in the past, the pipeline for RX to OTC switches seems to have slowed down in recent years.  In the 1990s and early 2000s, there were significant numbers of new categories of treatments making their way from prescription to drug store shelf. There were were also some attempts that did not make it, notably statins for the treatment of high cholesterol.


Ultimately, the switch for statins failed because an important element of any switch is that the drug can be used without the “intervention of a learned intermediary” – or in other words, can be used without a doctor.  I attended these switch meetings and the panelists were not convinced that the public understood cholesterol levels well enough and would lack the ability to monitor liver functions.  While you could take an OTC pill for a runny nose and know when your runny nose was no longer runny, you could not take a pill for your cholesterol and know when you had achieved your target.


But as technology made dumb phones smart, it may also put patients in a “smarter” place as well.  What if my wrist band that now monitors my sleep and steps and heartbeat can have non-invasive sensors that track all sorts of things from my sweat and an occasional pin prick?  Can a wrist band actually do all that?  A few short years ago, getting an ECG on a phone would have been inconceivable, today – not so much.


If an OTC product such as a statin had an app and a wrist band that came with the initial purchase of the product that would then allow you to self-monitor and electronically report the results to your physician, as my scale and blood pressure cuff do now, then perhaps we could be in an era where a whole host of monitoring functions could pave the way for new classes of OTC switches.


It was only about a decade ago that the switch attempts for statins occurred, but certainly times have changed.




Share this:



Share this page via Email


Share this page via Stumble Upon


Share this page via Digg this


Share this page via Facebook


Share this page via Twitter
 •  0 comments  •  flag
Share on Twitter
Published on July 25, 2013 10:22

July 19, 2013

Weekly Roundup 7-19-13


Ok.  I keep thinking summer is going to be the time when things slow down and I have a little more time for posting.   I’m not teaching over the summer, people are on vacation, life slows down, right?  Not so much.  Hopefully next week I will have a little more time for posting – I certainly have some good stuff I’m mulling around in my head, if I can just get it onto the blog.


In the meantime, here is a bit of what happened this week:



FDA Permits Marketing of First Brain Wave Test to Assess for ADHD – Certainly an interesting development here – the agency announced the approval for marketing of the first medical device to use brain waves as part of the assessment of attention-deficit/hyperactivity in children.  The device is to be used as part of a complete medical and psychological evaluation.  It is called the Neuropsychiatric EEG-Based Assessment Aid (NEBA) and is a 15-20 minute non-invasive test that works by calculating the ratio of two  brain wave frequencies.
Dr. Woodcock Again Addresses Regulation of Compounding – It was only in May that Dr. Janet Woodcock, Director of the Center for Drug Evaluation and Research (CDER) offered testimony before the House Subcommittee on Health, Committee on Energy and Commerce entitled “Examining Drug Compounding“.  She returned for a sequel this week when she offered another statement before the committee “Reforming the Drug Compounding Regulatory Framework“.  She set forth a framework that would recognize the two types of compounding – traditional and non-traditional (customizing an existing medication to suit a particular patient versus compounding a drug to meet a specific medical need).  She acknowledged that some products should not be compounded under any circumstances.  She stated that the agency should have the clear authority to collect and test samples of compounded drugs and collect pharmacy records and that there should be an accurate inventory of pharmacies engaged in non-traditional compounding – all of which might be supported through a user-fee type program.  Her testimonies, along with other compounding links are all housed on the Eye on FDA Compounding Tab on the blog site.
Congressional Update on Legislation – This was not introduced this week, but recently and has been added to the Proposed Federal Legislation – 113th Congress tab on the blog, where you can find several pieces of legislation that would impact FDA and/or industry.  First is H.R.2315 - Preserving Access to Orphan Drugs Act of 2013, introduced by Rep. Jim Gerlach, which would amend the Affordable Care Act (ACA) which would exclude orphan drugs from the annual fee due from manufacturers with sales exceeding $5 million.  The companion bill in the Senate is S.1128 and was introduced by Senator Pat Toomey.

That’s it for me after this long, hot week.  A cool front is coming through and I look forward to it.  Have a good weekend everyone.




Share this:



Share this page via Email


Share this page via Stumble Upon


Share this page via Digg this


Share this page via Facebook


Share this page via Twitter
 •  0 comments  •  flag
Share on Twitter
Published on July 19, 2013 11:40

July 12, 2013

Weekly Roundup 7-12-13


Don’t know about where you are, but here in Washington, D.C. the rain has been of epic proportions.  The gardens are getting a good long drink and I always like to think, whether or not it is true, that a good, wet summer means for a colorful autumn….


Last week because of the short week with the U.S. holiday, there was no Weekly Roundup so this week may contain a few items of note from last.



FDA Proposes “Action Level” for Arsenic Levels in Apple Juice – The agency announced that it was setting 10 parts per billion (ppb) as the “action level” at which FDA will consider an enforcement action when it finds that there is an amount of arsenic exceeding this level.  The press release does not provide any context or background so some may find it alarming that any arsenic at all is acceptable. However that is addressed in a blog posting to FDA Voices by Deputy Commissioner for Foods and Veterinary Medicine, Michael R. Taylor entitled “Why FDA Proposes an Action Level for Arsenic in Apple Juices“.  This level, he notes, is the same level that EPA has for drinking water, which is consumed in much larger quantities.
FDA Acts on Petition Regarding BPA in Infant Formula Packaging – In response to a petition filed by Rep. Edward Markey of Massachusetts (now Senator-elect Markey), FDA announced an intention to amend food additive regulations to no longer provide for the use of BPA-based epoxy resins as coatings in packaging for infant formula.  The petition contained information collected from a survey of all U.S. registered manufacturers of infant formula to support the claim that all U.S. infant formula manufacturers have abandoned the use of BPA-epoxy resins as coatings in all food contact packaging for infant formula.
GAO Publishes Report on Challenges of Regulating Rogue Internet Pharmacies – On June 27, FDA announced a very large action to protect consumers against potentially dangerous medications sold by Internet pharmacies involving over 9,600 sites.  This week, the GAO issued a report on just how challenging that can be.  Among other challenges, the 55 page report points out that rogue sites are difficult to investigate because they may be “composed of thousands of related websites, and operators take steps to disguise their identities.”  On top of that, of course, a site can exist anywhere in the world, crossing jurisdictions and other authorities.  It was a timely report given the fact that just a few weeks before, FDA apparently made it clear that despite the challenges, it can be done.
Postscript to the Quarterly NOV and Warning Letter Update - I received a communication via Twitter from a reader that the assessment I made near the end of the last posting on the Quarterly NOV and Warning Letter Update was incomplete.  I had stated that the minimization of risk was attributable to the fact that the product had a boxed warning and that while the statements made regarding the indication included bold faced print, the print for the risk information did not.  While correct, he stated that more to the point, FDA had stated that by putting the information on the previous page without any of the emphasis used with the efficacy claims (i.e., print, color scheme, borders, layout) that the risk information did not appear connected to the efficacy claims.  He was right – and hat tip for the correction.  The lesson from that letter was really the totality of the picture between the risk information and the efficacy information.  Thanks to the reader for the Tweet!

Wherever you are, may the sun shine on you.  May it shine on me too sometime soon.  In the meantime, have a good weekend.




Share this:



Share this page via Email


Share this page via Stumble Upon


Share this page via Digg this


Share this page via Facebook


Share this page via Twitter
 •  0 comments  •  flag
Share on Twitter
Published on July 12, 2013 12:24

July 10, 2013

Warning and NOV Letter Summary – 2d Quarter 2013

It is so hard to believe the year is half gone, but it is and that means – among other things – that it is time to look at the past quarter of enforcement letters from the Office of Prescription Drug Promotion (OPDP), formerly known as the Division of Drug Marketing, Advertising and Communications (DDMAC).  Each quarter we review what has happened by the numbers and look for any lessons that may be learned.


The first quarter was a slender volume, with only 3 letters issued in February and March. The second quarter was a little more active, but so far the year overall is rather slow compared to almost any previous year.  If we annualize this rate (in the chart below) 2013 will only see a total of 20 or so letters.



What of the 7 letters from this quarter.  There were 7 letters involving 7 communications vehicles. Therapeutically speaking, there were 2 in the CNS category, 3 in oncology, one in cardiovascular and 1 in opththalmology.  While none of the violations in the first quarter involved a digital property, 4 of the 7 for this quarter did – meaning that for the year, 40% of the violations so far were among digital properties.  The digital properties were, with 1 exception, were all Websites.  All of the letters for this quarter (and this year) have been Notice of Violation (NOV) letters – no Warning Letters.  And of note, 4 of the seven products had boxed warnings.


The 7 letters involved 16 violations:



Over one-third (n=6) of the letters involved the Omission or Minimization of Risk information;
Unsubstantiated Claims constituted 4 of the violations;
There was one Superiority Claim;
There was one Overstatement of Efficacy;
One involved promotion of an Investigational Drug;
Three were in the “Other” category – Two were Omission of Material Facts and another involved Misleading Claims.

The minimization or omission of risk was, as is almost always the case, the most common violation.  On this count, one of the more interesting letters from this quarter involved a DTC print ad for a product with a boxed warning which had copy that had many of the benefits listed in bold face for emphasis, but risk information to the side in small, regular copy with out any of the emphasis that was used in talking about the benefits.


All of this year’s letters have been added to the FDA OPDP Warning Letter database that I have put together, meaning that it now includes letters from 2004-mid-2013, containing 276 letters involving nearly 400 different communications vehicles and almost 900 violations.




Share this:



Share this page via Email


Share this page via Stumble Upon


Share this page via Digg this


Share this page via Facebook


Share this page via Twitter
 •  0 comments  •  flag
Share on Twitter
Published on July 10, 2013 03:47

July 3, 2013

Postscript – RSS Feeds – Choice Time

Got Google News Alerts set up?


A few weeks ago I wrote a posting about the pending shut down of Google Reader that was scheduled (and happened) after July 1.  I noted that it was time for people who, like myself, are highly reliant on RSS feeds and were Google Reader users to consider – if they hadn’t already – migrating their feeds elsewhere as I did.


However, a postscript is in order.  The shutdown did occur and my material migrated easily to a new reader I am using, but one thing stayed behind.


As part of my drive to know the news as it happens, I am an avid user of another Google Tool – Google News Alerts.  When you set up an alert, you have a choice to send alerts as-they-happen, daily, or weekly.  I am in need of knowing when many things happen as they happen and I happen to think I get too many emails, so I had a lot of material scheduled to come through “as it happens” and by my feed reader.


Well guess what?  When my feed subscriptions migrated to my new reader, the news alerts did not migrate with it.  In other words, Google News Alerts by feed reader were collateral damage to the removal of Google Reader.  It makes sense, but I didn’t think of it.  Now the only option on your Google News Alerts is to have them sent by old fashioned email…


So you may want to go to your Google News Alerts and edit any alerts that you had set up to send to your Google Reader and modify them to send to you by email.  Otherwise, you could find yourself like me, sitting in the dark with no news.  And in my business, no news is no news.




Share this:



Share this page via Email


Share this page via Stumble Upon


Share this page via Digg this


Share this page via Facebook


Share this page via Twitter
 •  0 comments  •  flag
Share on Twitter
Published on July 03, 2013 11:14

June 28, 2013

Weekly Roundup – 6-28-13


Where does the time go?  One minute dandelions are yellow and before you know it, they are fuzzy and blowing away in the wind….


It has been quite a week outside of our little world.  The Supremes sure were busy and did some stopping in the name of love.  In the meantime, here is a little of what happened that, while less momentous, is noteworthy.



FDA Approves 1st Recombinant Coagulation Factor IX for Prophylactic Use – We always love firsts and one happened this week when FDA announced approval of Baxter’s Rixubix for use in people with hemophilia B over 16 years of age for the controla nd prevention of bleeding episodes, perioperative management and routine use to prevent or reduce the frequency of bleeding as a prophylaxis.
Agency Announces 1st Decisions on New Tobacco Products Thru Substantial Equivalence Pathway – Yes, another first!  The Family Smoking Prevention and Tobacco Control Act of 2009 authorized FDA to review tobacco products to be marketed to determine if they are substantially equivalent to a valid predicate product already on the market.  In doing so, FDA determined that out of six reviews, two new products could be marketed and denied four others.  According to the agency’s release, any product that raises different questions of public health will be found to be not substantially equivalent and FDA said that a variety of factors went into the decision against the four that did not receive marketing authorization.  These decisions will provide the first insight into the agency’s approach to approval and non-approval.
FDA Takes Action Against Websites Selling Prescription Products - The agency announced this week that it had taken action against more than 9,600 websites that were illegally selling unapproved prescription medications to consumers as part of a global effort and in partnership with other regulatory bodies around the globe.  FDA said that the websites displayed fake licenses and certifications to appear legitimate.  The actions taken by FDA and the regulatory agencies involved the issuance of warnings and the seizure of offending websites as well as illegal medicines.

That’s it for me this week folks and I am sorry I was late to press today.  Busy week!  Hope you all have a wonderful weekend as we slip into July together….




Share this:



Share this page via Email


Share this page via Stumble Upon


Share this page via Digg this


Share this page via Facebook


Share this page via Twitter
 •  0 comments  •  flag
Share on Twitter
Published on June 28, 2013 15:45

June 25, 2013

Who is Doing What on Twitter?

Earlier this month, I wrote up a posting called “Twitter, Media and Pharma” about the transforming effects of Twitter on media reporting by journalists and consumption by patients.  Some people tweeted out the question – what will Pharma do?  Well, let’s take a peek.


As it turns out, some have done a lot, some have done a little and some have not done anything. Back in February, I mentioned that in addition to the FDA Warning/NOV data base I have been working on (See “Some Digital and Social Media Guidance – FDA Regulation of Pharma Communications in a Digital Era“) I was also putting together a data base that tracked the social media activity of pharma of which I have become aware. By social media activity, I specifically mean Twitter, Facebook, YouTube and Pinterest. By pharma, I mean pharmaceutical companies, biotech and device companies.


I do this for a few reasons.  One, by knowing what everyone is doing, it spells out opportunities.  Two, I think most companies are not actually aware of what other companies are doing in social media.  Three, I’m just that geeky.


Today, I’m going to focus just on Twitter.  Here is a little bit of what I found – bearing in mind this represents only that activity of which I am aware and does not claim to be the complete universe of pharma Twitter activity.  As I become aware of them, they are added to the data base along with a few characteristics, including the primary purpose of the feed.  Here is a bit of what can be observed:



All in all, have discovered about 227 Twitter feeds being run by 51 companies;
There are over 770,000 people following these Twitter feeds, which is up by about 50% since last July when that number was closer to 500,000 (this means that more people signed up and that I have added more feeds as I found them);
About one-third of the company Twitter feeds are updated at least daily while 1 out of 5 appear dormant;
The overwhelming majority (two-thirds) are “corporate” or general news feeds while only a handful were product-specific;
For job seekers, there are at least 21 feeds that are involved in recruiting (see below for the link to these);
The feeds with the highest number of followers were @Pfizer_News (Over 44,000), @Novartis (Over 40,000) and @Roche (Over 32,000);
Highest KLOUT scores however went to @GSK (87) followed by GEHealthcare (83) and @AstraZeneca (82) – very high scores.

If you are interested, the Eye on FDA Twitterfeed has a Twitter list of these pharma feeds where you can follow just that particular list.  I have also created a list for job seekers that allows you to only follow job postings from pharma and related feeds.  And lastly, there is a list of the FDA Twitter feeds so that you can follow only what FDA is saying.


Happy Tweeting everyone and remember.  Be safe out there.




Share this:



Share this page via Email


Share this page via Stumble Upon


Share this page via Digg this


Share this page via Facebook


Share this page via Twitter
 •  0 comments  •  flag
Share on Twitter
Published on June 25, 2013 06:46