Mark S. Senak's Blog, page 39

Upcoming AdComms by Subject Matter

In prior years, near the end of a calendar year, FDA would put up a schedule of Tentative Advisory Committee Meetings with tentative meeting dates scheduled for each Advisory Committee.  This year, however, the calendar went up, but very few dates were committed to meetings.

The meetings were always listed by committee and by date.  In February I provided an overview of upcoming advisory committees organized by subject matter and it turned out people seemed to like seeing what was coming in one spot sorted in that way, so here is an updated version.  The February posting was notable because there were very few drug approvals but this round has some interesting drugs and devices being considered.

ALLERGY

RX to OTC Switch – On May 2, 2014, the Non-Prescription Drugs Advisory Committee will meet to consider the RX to OTC switch application of trade name SINGULAIR for the temporary relief of symptoms due to hay fever or other upper respiratory allergies:  Nasal congestion, runny nose, itchy watery eyes, sneezing, itching of the nose.

AVERSIVE CONDITIONING

Safety and Efficacy Review – On April 24, 2014, the Neurological Devices Panel will meet to discuss the current knowledge about the safety and efficacy of aversive conditioning devices that are intended to deliver a noxious electrical stimulus to a patient to modify undesirable behavioral characteristics.

CARDIAC ARREST/FAILURE

PMA Approval Decision – On May 6, 2014, the Circulatory System Devices Panel will meet to consider an application for separate devices used together to enhance venous return to the heart and blood flow to vital organs during CPR to ultimately increase survival and neurologic outcome in patients suffering from cardiac arrest.
Classification of Systems – The following day the committee will consider classification of long-term pulmonary support systems during the first session and in the second session will consider classification of “More-than-Minimally Manipulated Allograft Heatt Valves”.

COMMUNICATIONS

Consumer Updates – On May 5-6 the Risk Communication Advisory Committee will meet to discuss how FDA can evaluate whether its Consumer Updates are effectively reaching the target population and increasing understanding of key risk messages and whether they are having the intended effect.

CONTACT LENSES

Guidance Documents – On May 13, the Ophthalmic Devices Panel will meet to discuss FDA guidance documents related to contact lenses and accessories.

OBESITY

PMA Approval Consideration – On June 17, 2014, the Gastroenterology and Urology Devices Panel will meet to discuss consideration of a PMA for an implantable device for the proposed indication for use in weight reduction in patients with obesity as the agency considers a ban on such devices.

ONCOLOGY

NDA Approval Consideration - On June 24, 2014, the Oncology Drugs Advisory Committee will be meeting to consider an NDA submitted by AstraZeneca Pharmaceuticals for olaparib for the proposed indication as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed ovarian (including fallopian tube or primary peritoneal) with BRCA mutation who are in response (complete or partial response) to platinum-based chemotherapy.

PAIN

NDA Approval Consideration – The Anesthetic and Analgesic Drugs Advisory Committee will meet today to consider an NDA from QRxPharma for MOXDUO (morphine sulphate and oxycodone hydrochloride) for the proposed indication of management of moderate to severe pain where use of an opioid analgesic is appropriate, representing the first drug combination utilizing two immediate release opioids.

Share this:

Warning and NOV Letter Summary – 1st Quarter 2014

Each quarter, I provide an overview of the most recent Warning and NOV letters from OPDP to gain insight into any lessons learned and to look at overall trends.  But this quarter, it is really slim pickings.  More than slim in fact.  This quarter, OPDP issued only two (2) letters. Still, remaining true to form, let’s take a look at them.

Needless to say this is not the norm, but if OPDP would continue at this rate, it would mean that for the year, there would only be eight letters, which would be the lowest number in a year.

Both of the products involved in the letters had boxed warnings. One involved a non-digital property – the other digital.  Between the two of them there were seven violations:

Risk Minimization – (2)
Superiority Claim (1)
Unsubstantiated Claim (1)
Broadening of Indication (1)
Omission of Material Facts (2)

Both letters this quarter were untitled letters and given that there were only two, they were both interesting.    Let’s take them in order.

The first of the letters involved a non-digital means of communication – a sales sheet. One of the more notable aspects of this letter was the number of violations. Five of the total 7 violations from these two letters involved the sales sheet.  That is a lot of violations for an Untitled Letter, though not that uncommon when the letter is a Warning Letter.  The most interesting thing in this letter was perhaps the fact that the sales sheet carried the claim that the product’s shorter dosing “streamlined” recovery.  That was taken to imply that recovery with shorter dosing was quicker and easier than compared to products with a longer dosing period.

The second of the letters, which had only 2 violations, was interesting because the vehicle was not only a digital property, but one involving Facebook – for which many in the pharma industry have an extreme sensitivity.  That was covered in a March 12 posting here, but the bottom line is that the fact that the violation occurred on Facebook was inconsequential and it would have been a violation if on Facebook or in a brochure.  It was not the medium, it was the message.

What accounts for the lull in enforcement that results in only 2 letters in a quarter? Perhaps everyone is keeping in line.  Or perhaps there is about to be another deluge of several letters issued in a day over some common practice such as happened in the Spring of 2009.  Hard to know.  But as it happens, we will continue to cover the developments here.

Share this:

Weekly Roundup – 4.18.14

There were audible gasps all over the Internet from people experiencing yet more snow this week – the week of Easter break for many.  Freeze warnings here threatened my young herbs planted only a few days before over a warm and languid weekend.  But at last, it appears that Spring has made its arrival, just lacking a little in confidence.

But there hasn’t been much of a thaw at FDA.  Not many press releases, no speeches, no testimonies and very little warning letter action.  Still, here are a few tidbits from the week that I thought would be of interest:

New Type 2 Diabetes Drug Approval - FDA announced approval of GSK’s Tanzeum (albiglutide), a once-weekly subcutaneous injection to improve glycemic control for adults with Type 2 diabetes.  The agency said that the drug was being approved with a Boxed Warning and a REMS program as well as a requirement for several types of post-marketing studies, including dosing, efficacy and safety in pediatric patients and a cardiovascular outcomes trial.  According to the company release, albiglutide has been approved in Europe in March and expects to launch in the U.S. sometime in the third quarter of this year.


FDA Approves New Allergen for Ragweed - Earlier in the month FDA approved the first sublingual allergen extract for the treatment of grass pollen allergies and this week approved the first sublingual product to treat short ragweed pollen induced allergic rhinitis (also known as hayfever).  The newly approved product, called Ragwitek, is to be used 12 weeks before the beginning of the ragweed season with the first dose being administered in the physician’s office and the balance at home.  There is a Boxed Warning for the product informing that severe allergic reactions, some of which can be life threatening, can occur and the product will come with a MedGuide.


IMS Report on Medicine Use – The IMS Institute for Healthcare Informatics released the report – “Medicine Use and Shifting Costs of Healthcare:  A Review of Medicines Used in the U.S. in 2013″.  Among other things, the report finds that after a decline in 2012, drug spending increased in 2013 once again, new products were launched and fewer patents expired.  It is filled with a wealth of information from the fact that prescriptions for pain meds dropped by 1 percent to an increase in contraceptive medications by 4.6 percent.  The release of the report includes videos overviewing the key findings and if you want the report you can download it from the IMS Institute site or you can get the IMS Health App on an iPad and get it there, which is pretty neat.


FDA Discourages Use of Procedure for Removal of Uterine Fibroids – FDA made a safety related announcement yesterday that made the front page of some papers today.  The agency announced this week that the use of laparascopic power morcellation – a procedure that is one of several available for treatment for fibroids – was discouraged as a treatment by the agency after finding that approximately 1 in 350 women who are undergoing a hysterectomy or myomectomy for fibroids have an unsuspected type of uterine cancer.  The procedure works by dividing the tissue into smaller pieces or fragments that can be removed through laparascopy. FDA said there dis a risk the procedure could spread the cancerous tissue, thus posing a risk.

That’s it for me this week folks.  Please have a good weekend.

Share this:

Release of CMS Medicare Payment Data a Sunshine Dress Rehearsal

There were two major healthcare stories last week.  One involved the announcement that Health and Human Services Secretary Kathleen Sebelius would be leaving and the nomination by President Obama of Office of Management and Budget Director Sylvia Mathews Burwell to replace her.  But also last week CMS made an unprecedented release of Medicare payments data.  For the first time since 1979, the public had access to information regarding which physicians received what kind of sums under Medicare. Media stories were extensive and primarily focused on the amounts of money that went to providers.

For some time now, preparation has been underway for full implementation of The Sunshine Act, incorporated into the provisions of the Affordable Care Act.  Under that law, there will be a similar release of information, only this will focus on payments made from the pharmaceutical, biotech, and medical devices industries to physicians and teaching hospitals.  CMS has been in the process of implementation of the Sunshine Act for some time now and the culmination will be in the first scheduled publication set for the end of September, 2014.

There were many angles to the CMS story to explore in the stories.  But perhaps one of the most important aspects of CMS Medicare announcement for the medical products industry is the fact that it served as a media “dress rehearsal” for the publication of data under the Sunshine Act provisions later this year.

Coverage of the CMS news was broad – spanning many national outlets.  It was both a national story with headlines focused on the top grossing physicians as well as those specialties that saw the highest payments, and a regional one – where local physicians were assessed as seen in this piece from Arkansas Business.

The primary focus was squarely on the amounts of money received by physicians. While many reports carried caution that the whole story did not end there – that there were reasons behind the numbers – the fact that large amounts went to a small group of physicians stood out.  Beyond the individual physicians, there were reports profiling particular physician specialities – oncologists for example.  Some of the messaging around the “behind the numbers” issue worked, some of it did not.  That is something to look at.

There is every reason for one to expect the same type of coverage for the release of information under the Sunshine Act coming in the autumn of 2014.  Again, a good deal of the focus will likely be on the numbers, and there will be some additional messaging about the story beyond the numbers, but the stakeholders may be broader.

First, of course, will be individual physicians who will see a focus on amounts they received.  Second will be the medical societies of particular physician practices where there may have been more interaction with industry than others.  And third will be industry with a focus on everything from comparative amounts expended to exploration of the relationships between the funding and product marketing.

In the field of issues management, it is rare that one gets the opportunity to look at a blueprint and to have the luxury of time to develop messaging ahead of an event. This is one of those rare times.

On their websites, many medical societies have given members overviews and tools to learn about how the Sunshine Act works.  But it may also benefit the membership to have a framework for how to talk about their participation in various industry programs once it is released. There is a story beyond numbers. Members may also face regional stories if they stand out in a particular region or state.  A webinar on the topic may for members might benefit many.

Similarly, industry has been working to aggregate and submit data – it is also time for companies and their trade organizations to examine the coverage from this release of data with an eye for preparation:

Begin with both messaging and strategy regarding the release of numbers, decide what worked, what didn’t.  What is the story beyond the numbers?
What does it mean to sit on an advisory board?  What are the benefits to patients from the relationships that are developed with physicians?
And, given the benefit of time for planning, in addition to preparing for responding to inquiries, stakeholders need to assess to what extent some proactive efforts might be a good idea.

There is a good deal of time between now and the time the Sunshine data is released. Developing and assessing messaging now – considering strategy and possible tactical execution – is probably time and effort well spent.  In the end, preparation will not do away with the negative connotation associated with money, but it can help to paint more of the background picture so that there is greater context associated with the coverage of the release of data.

Share this:

Weekly Roundup 4.11.14

A few weeks ago it was snowing.  Today, a walk around the neighborhood yields views of piles of mulch near driveways ready to be loaded into wheelbarrows and spread into the garden beds.  Bags of topsoil are lined up.  Grass seed is nearby and already the grass appears to be putting forth bright green shoots.  The birds are noisy.

Transitions happen before we know it.  One minute we are complaining about snow and the next, there is a pollen alert.  Here are some news items to mark our way down the path:

FDA Expands Indication for Some Pacemakers and Defibrillators –   FDA approved an expanded indication for two pacemakers and eight defibrillators for use in patients with less severe heart failure.  The devices had been approved for severe heart failure use.  The agency spokesperson stated this could delay the occurrence of heart failure related urgent care for people who meet the new criteria.  The devices are manufactured by Medtronic.


Internet Ad Spending Beats Broadcast TV Last Year - For the first time it was reported by Mashable that revenue spent on advertising on the Internet surpassed that spent on broadcast television.  Not sure if that is true for the pharma industry or not, but it certainly signals that if not yet, it will likely be soon.  And for FDA, it signals that enforcement efforts, long centered by OPDP on broadcast, need to be approaching their efforts in new ways, taking into consideration a lot of new factors.


Predictability and Transparency in DEA and FDA Regulation - On April 7, Dr. Janet Woodcock, Director of the Center for Drug Evaluation and Research, provided a statement before the House Subcommittee on Health, Committee on Energy and Commerce that outlines and explains some of the massively complicated situation regarding the regulation of sunscreens.  One might not think that the oversight of sunscreens could possibly be so involved, but if you want to gaze into the labyrinth, by all means, take a look.


And a Timely Alert About Lillies – In time for the Easter Season, FDA has provided an alert about the fact that kitties and lillies may not mix very well. According to the agency, the entire plant – leaf, pollen and flower – are all toxic to our feline friends.  Symptoms can include lethargy, vomiting and loss of appetite which can worsen as kidneys are affected and can prove fatal and early treatment is extremely important.

That’s it for me this week.  I am finally for the first time in many weeks not on the road, so I will be more regular in this space.  Have a good weekend everyone.

Share this:

Sunset on the ROI of Social Media and Pharma Discussion

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

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

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

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

Share this:

Weekly Roundup 4.4.14

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

Approval of Sublingual Allergen Extract - FDA announced approval on April 3 of a new tablet called Oralair manufactured by a French company called Stallergenes.  Oralair is a once-daily dose and indicated for the treatment of hay fever induced by grass pollens and is the first under the tongue (sublingual) extract approved in the United States.  The first dose is administered in the physician’s office and thereafter can be taken home for use.  Oralair contains a mixture of freeze-dried extracts of pollens of five different grasses, including Kentucky Blue Grass, Orchard, Perennial Rye, Sweet Vernal and Timothy.  One interesting note for those of us in the pharma communications trade – FDA’s press release came out two days after the company announced approval with its own release dated April 1 and hence the unusual language in the FDA release that was dated April 3 which stated that the agency had “recently approved Oralair”.


Opioid Overdose Treatment – It is an unfortunate circumstance that drugs meant to alleviate the serious pain of people suffering from disease are not only often abused, but in a way that puts a life in danger from overdose.  In fact, drug overdose deaths are not the leading cause of injury death in the United States, according to FDA, suppressing motor vehicle crashes.  This week FDA approved a new hand-held auto injector to be used in an attempt to reverse the effects of an opioid overdose treatment that can be used by families or law enforcement for emergency treatment called Evzio.  Evzio contains a single dose of naloxone that is administered by a hand held auto-injector.  This is a step forward over what had been the status quo which involved administration by syringe from trained medical personnel.  The announcement was accompanied by a statement from Commissioner Hamburg regarding FDA efforts to combat prescription drug abuse.


Battlefield Wound Dressing - More successful innovation emerged this week when FDA announced it would allow marketing of an expandable sponge that could be used under emergency circumstances to control bleeding for “certain types of wounds received in battle.”  FDA’s release notes that the U.S. Army says that nearly half of all combat deaths are due to bleeding out and that approximately half of those could be saved if appropriate care – presumably something to stop the bleeding – could be available.  The sponges are administered by syringe and expand into the wound and are later removed from the body.  To support the removal process, each sponge contains a marker that is visible when X-rayed.

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

Share this:

Weekly Roundup 3.28.14

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

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

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

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

Share this:

Weekly Roundup 3.14.14

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

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

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

Here is a bit of what caught my eye.

Pew Creates Excellent World Wide Web Timeline – That never-ending font of all things good related to knowledge and research involving the Internet – the Pew Internet Research Project – put together a most excellent timeline to mark the 25 year anniversary of the World Wide Web.  The web, which involved a whole bunch of information made foundable by the development of search and about which we wanted to talk about in via our new interconnectedness that began with email and instant messaging and went on to all forms of social media, bears some remarkable milestones, many of which were relatively recent.  A few of my favorites – 1990 – 42% of American adults have used a computer; 1996 – 77% of online users send or receive an email every few weeks; 1997 – Google registers as a domain… and there are many more gems.  Check it out here.


Migraine Device Approved – If you saw this, you might have been confused like I was at first.  On March 11, FDA issued a press release entitled “FDA Allows Marketing of First Medical Device to Prevent Migraine Headaches“.  Why confused?  Because it said “First” and yet I had a tremendous sense of having seen this before.  So, I consulted my new, handy, dandy data base that I made of FDA press releases and did a sort on “Approvals, Devices and Migraine” and there it was from December 2013 – “FDA Allows Marketing of First Device to Relieve Migraine Headache Pain“.  And so, mystery solved – the most recent was to prevent migraines and the earlier was to relieve.  Two different devices, two different companies, one prevent and one relieve.  One interesting thing of note here – the December 2013 announcement on the device to relieve migraine pain was also released in Spanish.  The 2014 announcement about the device to prevent migraines was only released in English.  It is a challenge to those of us trying to discern the pattern here.

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

Share this:

OPDP Issues Untitled Letter Involving Social Media

Sort of.

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

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

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

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

Share this: