Mark S. Senak's Blog, page 49

Warning and NOV Letter Summary – 3rd Quarter 2012

Each quarter Eye on FDA examines what has occurred in enforcement by the Office of Prescription Drug Promotion (OPDP), formerly known as the Division of Drug Marketing, Advertising, and Communications (DDMAC).  Apart from being instructive for those working in communications and medical products, in the absence of specific guidance documents, these letters are the only means for gaining insight into the agency’s current thinking regarding communications around medical products.

Looking at the broader picture, overall enforcement appears to be on the wane once again at the OPDP.  The past quarter brought the total number of letters issued during 2012 up to 23.  Barring a flurry of letters in the 4th quarter, this pace would have the agency just below last year’s 30 and far below the 52 letters issued in 2010, and of course a far cry from where it was before 2002.

Looking specifically at the third quarter, there were only 5 letters issued citing 9 different violations.  Of the 5 letters, 3 were aimed at traditional media communications vehicles (Oral statements made by a sales rep and two brochures) while 2 were aimed at digital communications (both Websites).  Only 1 of the letters was a Warning Letter (the drug label on that one had a boxed warning) while 4 were Notice of Violation (NOV) letters.

Contrast that for all of 2012 so far, there were 23 letters for the year citing different violations.  Of the 23 letters, 17 were aimed at traditional communications vehicles, while 6 were aimed at digital (none involved social media).  There have been 4 Warning Letters compared to 19 NOVs.  Of those receiving Warning Letters, 2 involved drugs with boxed warnings.

Normally the number one violation cited involves a minimization or omission of risk information, but this quarter there were only 2 of those, along with 2 Superiority Claims, 2 Overstatements of Efficacy and 2 Broadening of Indication.

Next quarter will summarize both the quarter and provide a comparison to the entire year for 2012.  Look for it in early January.

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Note:  Post publication an astute reader noted that my math didn’t add up where I stated that of the 23 letters, 18 were traditional communications vehicles while 6 were digital – it should have been 17 traditional and 6 digital, which of course does add up to 23.  Thanks again to the reader for pointing out and apologies for the error.

Who Ya Gonna Call?

Today Mashable carried an article entitled “Twitter’s Surprising Reaction to Meningitis Outbreak” that reported that as the meningitis outbreak associated with a contaminated steroid product unfolds, users of Twitter were more often searching for CDC than FDA. The fact that the general public – at least as represented by Twitter searches – look to CDC more often than FDA in this circumstance is interesting, but perhaps not surprising when one really thinks about the nature of the two agencies.

Consider first, CDC is likely to be considered the guardian of the public’s health perhaps more than any other agency when it comes to disease prevention and works hand in hand with FDA whenever an issue emerges over one of the products regulated by the latter.  For example, when there is a food-borne outbreak, CDC may detect and track illnesses associated with the contamination while FDA will work to investigate and contain the spread.  When the issue is a drug rather than a food that is the source of illness, the same would apply.  When seeking information about the condition caused by the outbreak one would naturally seek out the agency that is associated with disease (i.e. the agency with the word “disease” in its name).  When seeking information about the product that is the subject matter involving the outbreak – either food or drug – one would naturally seek out the agency that regulates them (and has those words in its name as well) .

A second factor is that CDC’s communications agenda is more focused and straddles fewer stakeholders than FDA’s.  CDC has a large focus on the public, while FDA must straddle audiences ranging from the public to manufacturers of a huge span of products covering one-quarter of the economy.

Lastly, a recent review in September done here of federal public health agencies influence on Twitter, as measured by KRED, demonstrated that CDC has acquired a good deal of influence on Twitter – more than any other federal health agency, which should also not be too surprising given the CDC’s willingness to push the communications envelope with efforts such as Preparedness 101:  Zombie Apocolypse.

Boxed Warnings and Warning Letters

Last week I reported on some of the activities during the Food and Drug Law Institute meeting on Advertising and Promotion which I attended here in Washington, where many aspects of enforcement were discussed.  I had some data I did not get to present, so thought I would write about it now.

When FDA wants to draw attention to a particular risk with a prescription drug product, the package insert for the product will often contain a boxed warning.  It is just what you would think it is – a box with a warning in it and almost everyone connected with the marketing of these products is aware of the existence of the boxed warning, sometimes also called a “black box warning”.

But are there communications implications to having one in the label? It turns out there may be.  Looking at FDA’s boxed and warning letters from 2006 through the second quarter of 2012 (inclusive), by my count there have been 206 letters sent by the Office of Prescription Drug Promotion (OPDP – formerly known as DDMAC).  Those letters are divided into two types – Warning Letters (WLs) and Notice of Violation (NOVs) letters – also known as “Untitled Letters”.  WLs are regarded with more significance than NOVs. And finally, the thing of note for communicators.

Of the entire group of 206 letters sent in the five and a half year time frame, about 32% of them have been WLs – while 68% have been NOV letters – so for every WL issued, there are two NOVs. But when we look at drugs that have boxed warnings, the picture changes.  Within this time frame, I found only 20 instances where a product with a boxed warning received either a WL or NOV letter.  However, of the 20 WL/NOV instances, a WL was issued 55% (n=11) of the time or WLs are even more common that NOVs. That would seem to indicate what common sense might already be telling you – when you are working with a product that has a boxed warning, efforts to ensure that you are communicating within regulatory parameters – while always paramount – should be given extra attention.  In other words, if you are promoting a drug with a boxed warning, “handle with care.”

FDLI Conference on Advertisting and Promotion

The Food and Drug Law Institute held its annual conference on Advertising and Promotion for the Pharmaceutical, Medical Device, Biologic and Veterinary Medicine Industries in Washington, D.C. on October 1 and 2.  I was able to attend sporadically and participated on a panel the second day on Social Media and Medical Product Companies.

The conference had strong attendance, with several pharmaceutical companies present as well as those of us who work with them.  FDA was represented in force and the agenda patterned that of previous years, starting out with updates regarding enforcement from each CBER, CDER, CDRH and CVM.  The one from CDER provided a few case studies from enforcement since last year, covered the name change from DDMAC to the Office of Prescription Drug Promotion (OPDP) and though listing the development of guidances as one of the top priorities, specifics were short in supply and overall the presentation was looking back and not forward.

In a presentation offering Updates on Guidances, FDA offered a thorough review of the draft guidance on responding to unsolicited requests for off-label information about drugs and devices.  It was a good presentation and anyone seeking information about that guidance should review the deck.  For those of us waiting for an update on the draft guidances related to social media which are now years behind schedule, we apparently have longer to wait.

The panel that covered Trend in Enforcement that included a presentation from the HHS Office of Inspector General concluded with some view to the future that included continued large numbers of cases involving pharmaceutical manufacturers and medical device manufacturers and a continued focus on individual accountability within organizations.

My panel was on social media and we were asked to provide hypothetical social media situations that presented questions for discussion.  The problem is, of course, that with FDA’s inability to provide timely guidance in any form on the topic, almost any discussion of any social media activity involves more questions than answers.  The hypothetical that I devised dealt with a pharmaceutical company that made a new HIV drug that was the subject of a blog posting by a well-known AIDS Activist whereby he discussed the positive impact that the HIV treatment had on his Hepatitis C.  He was widely read by media and patients alike and he posted links to the blog posting on the corporate Facebook page of the company – which were then taken down.  The resulting controversy resulted in a great deal of publicity over the potential off label use.  It was meant to characterize the current state of the environment where the lack of guidance may actually be a catalyst to cause the spread of misinformation.

Many other important subjects were discussed during the two days.  If you are intersted, there are links to all of the presentations here and in fact, FDLI has a link on this page which will allow you to download all of the presentations into a single file.  The hashtag for the conference was #FDLIAP if you are interested in seeing tweets sent during the two days.