Join Me for a Webinar – Communications Implications of the Sunshine Act Data

I don’t usually do adverts here on the blog – in fact never, but you may remember a posting I did a few months back on the communications implications of the Sunshine Act implementation.  There is room to be expansive upon the topic beyond a blog posting and so that end, I will be giving a Webinar on the topic this Thursday, June 19 at 12 noon Eastern.

At the end of September, the government is scheduled to publish financial data it has been gathering to create greater transparency on the financial relationship between industry and prescribers.  Manufacturers, teaching hospitals, physicians and medical societies are all stakeholders.  What kind of stories can be expected as a result and what should be done now to prepare?  I’ll be sharing some thoughts on the matter.

The Webinar is free and if you would like to join us, here is the link.

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Weekly Roundup 6.13.14

It is hot.  It is humid.  Mosquitoes have begun to make their presence known.  Thunder and rain showers occur almost daily.  Summer is truly here.  And we are making our way rapidly to my favorite day of the year – the day with the longest daylight is just over a week away. Seems like only yesterday I was lamenting about the lack of daylight.

The summer seems off to a slow start, but here are a few things of note from the week:

  • Cheese – Yes cheese.  It was a main topic for the week.  There was a groundswell of reaction to reports that FDA was moving to disallow artisan cheese makers to use wood shelving when aging their product.  Certainly my Facebook page lit up on both sides of the Atlantic with comments that included a good deal of scorn related to this news.  The reaction reached such a pitch that the agency responded by posting a clarification on its Website stating the following:  ”To be clear, we have not and are not prohibiting or banning the long-standing practice of using wood shelving in artisnal cheese….The communication was not intended as an official policy statement, but was provided as background information…”  Thank goodness, the matter is apparently laid to rest.
  • Fish. Yes, it is all about food this week.  While the cheese issue was being resolved, FDA and the EPA joined together to issue notice that they have concluded that pregnant women, those women who might become pregnant, and young children should eat more fish that is lower in mercury in order to gain developmental and health benefits.  While the agencies had previously cited a maximum amount, they had not cited a minimum amount of fish to consume.  The notice came after an analysis of consumption data showed that out of 1,000 pregnant women, 21 percent had eaten no fish the previous month and those who did were eating small amounts.  The updated advice recommends 8-12 ounces per week.  Lower mercury choices were listed as shrimp, pollock, salmon, cannled light tuna, tilapia, catfish and cod.
  • OPDP Issues Only 4th Untitled Letter for the Year – For those of us watching the edicts of the Office of Prescription Drug Promotion closely, we are left wondering what is going on at that office.  OPDP in 2014 has proceeded with enforcement at a record slow pace, issuing only the 4th letter of the year this week. Normally by this time of the year they would have issued at least twice that many, judging by the past few years.  It is noteworthy because guidances and these letters are two of the only insights that the outside world has into understanding policy from FDA – and there has not been much of either.

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

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Warning and Untitled Letters By Therapeutic Category – Oncology

Ever since developing a data base on the Office of Prescription Drug Promotion (OPDP) Warning and Untitled letters, I have wanted to sort the information along various lines to see differences and similarities given different circumstances.  Last year, I produced a White Paper, for example, comparing violations by traditional communications vehicles versus those carried by digital means.  I also did a posting that looked at a particular violation – promotion of an investigational compound – to see what the characteristics of that particular violation.

The data is tracked along a number of fields and one of them is the therapeutic area for which a drug involved in a violation.  Therefore I thought it might be interesting to look at specific areas to profile them against the aggregate.  Today I chose to look at all violations involved in oncology.

First let’s review the overall violations.  There are 390 letters spanning the years 2004-2014, inclusive and covering over 1000 violations.  Here is a table that compares Oncology to the entire group:

How does Oncology differ? One of the surprising things perhaps is that Oncology products account for over half (62.5 percent) of all violations related to promotion of an investigational drug.  Given the fact that there are numerous disease-specific categories, this was a surprise and perhaps sounds a word of caution about pre-approval communications for oncology products.

Also of note, oncology related letters had a lower proportion of warning letters than the general population of letters.  That too is surprising given the serious nature of the drugs involved

As seen below, oncology was also under-represented in terms of the most common violation – the omission or minimization of risk information, but more represented in the category of overstating efficacy.

Finally, there were many more violations in the “other” category for oncology.  This is a hodge-podge of less common violations, with perhaps the most common being a “failure to submit” materials under 2253.

So there are a few lessons about oncology worth noting.  Over time, I will examine other categories of treatment.

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Weekly Roundup 5.30.14

This is just awful.  A whole week without a posting.  Not because I did not have anything to talk about, but because I did not have anything like time on my side.  It was one of those weeks.  I did have time during my dog walks, however, to note that my neighborhood is almost wholly infused with the sublime scent of honeysuckle, reminding me of being a child in my grandmother’s garden.  I have always liked honeysuckle.  It is also a harbinger in my mind that summer is just about here.  As a kid, the period after Memorial Day was the beginning of summer, even though it doesn’t officially begin until later in the month, emotionally speaking – it is summer!

And for those not interested in that, but in FDA, there were a lot of things popping this week and here are a few of them:

  • FDA OKs Test for Identifying Certain Types of Kidney Disease – The agency announced this week that it would allow marketing of the first non-invasive test that would help identify when a specific type of kidney disease is due to autoimmune causes or because of infection.  The condition is called membranous glomerulonephritis (MGN) which is a chronic disease that can cause damage to a cluster of blood vessels in the kidney and which can damage the kidney as it progresses.  The test is called the EUROIMMUN Anti-PLA2R IFA blood test.  Since treatment depends on the kind of disease one is experiencing, the test can help in getting access to treatment according to the FDA spokesperson.  While the test helps determine the cause, the test should not be used alone to diagnose.
  • Agency Approves First Implantable Device with Remote Monitoring to Measure Pulmonary Artery Pressure – There was just no way to shorten that headline.  But speaking of approvals of a first kind for a device, here is another one. FDA approved CarioMEMS HF System which is an implantable wireless device that measures the pulmonary artery (PA) pressure and heart rates of patients with Class III heart failure who have been hospitalized within the previous year.  The goal of having such a system is to reduce possible future heart failure-related hospitalizations by providing data from the home that can be reviewed by physicians who can then make treatment decisions.
  • Draft Guidance on Proprietary Names of Drugs – A not uncommon question about drugs is about the process for naming them.  Here to shed some light on the process is a draft guidance issued by FDA entitled “Best Practices in Developing Proprietary Names for Drugs“.  It focuses on the safety aspects for naming, i.e., avoiding medication errors with similar names and provides a systematic framework for evaluating names before submitting them to the agency for review.  FDA held public meetings in 2003 to discuss the topic and again in 2008.  Interested persons can comment on the draft guidance at
  • Final Guidance on Expedited Programs for Serious Conditions – Drugs and Biologics – After initial publication last year on a draft guidance, FDA issued a final guidance entitled “Expedited Programs for Serious Conditions – Drugs and Biologics” that is intended to speed the availability of new therapies to patients with serious conditions, especially when there are no satisfactory alternative therapies, while seeking to preserve the standards for safety and effectiveness.  Among other things, the Guidance provides definitions for the concept – a serious condition, available therapies, unmet medical need and delineates the differences between Fast Track, Breathrough Therapy, Accelerated Approval and Priority Review.
  • Before You Get in That Tanning Bed – You should probably know that this week FDA moved to reclassify sunlamp products from Class I (low risk) to Class II (moderate risk), requiring the products to carry a visible black-box warning that explicitly states that it should not be used on persons under 18 years of age and added information and warnings to be included in marketing materials.

That’s it for me this week.  Again sorry for the lack of posts this past week.  Busy, busy, busy. Have a good weekend everyone!

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Weekly Roundup 5.23.14

We were all feeling a little pent up this Winter and delighted to see Spring.  And what is more delightful than seeing others delighted?  Check out the Weekly Roundup video of dairy cows greeting the meadow after a winter in the barn.  It will make you feel good.

And while you are busy feeling good and before enjoying the holiday weekend, take note of a few of the things that happened this week out of FDA:

  • FDA Moves on Illegal Online Pharmacies – In conjunction with other federal and international agencies, FDA went after online pharmacies selling unapproved prescription drugs to U.S. consumers.  Inspections were conducted at U.S. based international mail facilities resulting in discovery of many packages that were ordered from online sources outside of the U.S.  The action was part of an operation that resulted in detention and seizure of nearly 20,000 packages containing unapproved or counterfeit drugs.  According to the FDA spokesperson people ordering drugs outside of the legitimate supply chain cannot know if the product they receive even contains the correct active ingredient, dose or even if it is the intended medicine.
  • FDA Approves First Gene-Based Test to Determine Red Blood Cell Types in Transfusion – BioArray Solutions Ltd. of Warren, New Jersey received approval for its Immucor Precise Type Human Erythrocyte Antigen (HEA) Melectular BeachChip Test, the first molecular assay to be used to assist in determining blood compatibility in the U.S.  The product was reviewed in March by the Blood Products Advisory Committee.  An FDA spokesperson was quoted as saying that the assay “provides an alternative to serological typing and may enhance patient care in certain situations”.
  • FDA Approves New Ulcerative Colitis and Crohn’s Disease Treatment – An injectable to treat adults with moderate to severe ulcerative colitis and adult patients with moderate to severe Crohn’s disease  was approved this week by FDA.  While not a cure, the treatment offers a new option for patients who have not responded adequately to convention therapies.  Entyvio is an itegrin receptor antagonist.  While no cases of progressive multifocal leukoencephalopathy (PML) were seen in clinical trials of this drug, PML has been seen in use with another type of integrin receptor antagonist and so post-marketing studies will continue on that front.

That’s it for me this week.  Kick back and enjoy your time in the meadow.

Video courtesy of Anne Becker.

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