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.


  • 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.


  • 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.


  • 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”.




  • 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.


  • 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.


  • 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.

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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.

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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.

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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.

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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.

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