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 www.regulations.gov.
  • 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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Media, Science and Emerging Pathogens – Communications in a Time of Outbreak

Accuracy and consistency in communications is always important.  On important issues, misinformation can lead to serious consequences.  That is especially true in the field of public health.

In watching the media coverage of the outbreak of  Middle East Respiratory Syndrome – known as MERS – one cannot help but to be reminded of the early days of the AIDS epidemic.  And of the SARS outbreak in 2002-2003.

In the earliest days of AIDS, the disease was identified by those whom it seemed to most affect – homosexuals – and so the first name for it was Gay Related Immune Deficiency or GRID.  As the epidemic spread beyond the initial epicenter, it was proposed that the name be Acquired Immune Deficiency Syndrome or AIDS.

MERS has its name based on its place of origin – the Middle East.  But cases have been spreading both numerically and geographically, with the first cases imported into the U.S. this month, followed by the first case of transmission.  SARS – which like MERS is a coronavirus – was an outbreak that began in 2002 in Asia and spread to other regions around the globe.  SARS stood for Severe Acute Respiratory Syndrome and did not have a name based on its geography of origin.

It is better for public health officials to avoid using a name for an emerging pathogen that is tied to a geography or a particular group of people who are affected for three reasons. First, when the pathogen moves on from either the geography or people, the name is no longer really accurate – but historical.  And second, disease – particularly communicable disease – stigmatizes. Stigma is an enemy of public health for  host of reasons. Third, people outside the target zone may feel a sense of false security.

The reporting on MERS has picked up in the U.S. since the appearance of some imported cases and one apparent transmission in this country.  As a consequence, that means more people are writing about a condition not wholly understood, increasing the likelihood of speculation and error. Under those circumstances, consistency can easily be disrupted which in turn, can undermine public understanding and confidence in what is being reported. In addition, circumstances change as medical understanding advances. In this article from 1982 on AIDS, it is stated that “epidemiologists have found no evidence that the condition is spread from person to person like influenza or measles. Therefore, they say, the general public need not fear an epidemic.”  In other words, understanding is going to evolve.

A great public service – either on the part of a governmental agency or a non-profit – would be to provide a writer’s guide for journalists on emerging pathogens where the latest information could be housed – not just on MERS, but on Ebola, H7N9 or whatever else comes our way. This would be beyond Q&A, but would provide insight into the nuances of each as well as providing insights into best reporting practices from a public health perspective. It could be especially useful in today’s environment where many reporters are generalists and not healthcare specialists and many are citizen journalists.  And the beauty of an electronic writer’s guide is that it could be regularly updated with information from several sources.

Everyone has learned a lot since the early days of the AIDS epidemic, no doubt.  But there is always room for improvement.

Photo:  CDC/Maureen Metcalf; Azaibi Tamin

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Weekly Roundup 5.16.14

The Weekly Roundup is late after a much-needed day of respite.  Sorry about that.  A little bit of Spring Fever mixed with a lot of need to catch up on things around home.

In any case, there is a little that happened this week, some of which is of great interest.

  • Lower Starting Dose for Sleep Drug - A label change was announced this week when FDA decided to lower the recommended staring dose for sleep aid Lunesta (eszopicione).  The move was to avoid the possibility that levels in some patients may be high enough the morning after that activities and alertness could be impaired and therefore the agency was recommending that the starting dose be cut in half from 2 milligrams to 2 for both men and women, leaving less drug remaining in the body in the morning hours.  Last year, FDA also announced dose reduction for other sleep drugs containing zolpidem.
  • HIV Prevention Through Medication –  PrEP – or pre-exposure prophylaxis is accomplished through the use of a single pill that contains two medications used to treat HIV.  CDC is recommending that individuals who are at high risk of HIV exposure that daily use of these medications can be a prophylaxis strategy to consider.  The agency is recommending that PrEP is for people who do not have HIV, but are at substantial risk – which is considered to be someone, for example, who is in a relationship with an individual who has HIV.  CDC will be holding “Grand Rounds” on the topic this Tuesday, May 20 from 1-2 PM.
  • MERS On the RiseWHO noted this week a number of MERS cases – the Middle East Respiratory Syndrome – and while the reported cases appear to rise in number, there has also been a growing geography with not only the first imported cases into the U.S., but also reports of the first in-country U.S. transmission in Illinois – a case where the exposure did not apparently result in illness.  The news prompted an update from the Centers for Disease Control, a transcript of which can be found here.

That’s it for me this week.  Sorry about the tardiness.  Hope you all had a good weekend.

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