Inside the Penalty Box – Black Box Warnings and CMS

In the past in this space, I’ve written about the need to discover more about the effect of Black Box Warnings and whether or not their intended role as a risk management tool is truly fulfilled.  Anecdotally one hears that many physicians would not prescribe a drug with a Black Box Warning, but when their patients are audited, in fact, they are.  It is truly unknown what the impact of a Black Box Warning is – does it keep prescribers from prescribing and does it have any impact on raising consciousness about risk?

Nevertheless, according to an RPM Report, when the FDA slaps a Black Box Warning onto a drug, Medicare Part D formularies may be allowed pull the drug from coverage.  The report appears to be true if one reads the CMS memorandum covering this issue.  Apparently, there are certain circumstances that allow a formulary to be changed mid-course.  A Black Box Warning is one of them. 

This is a somewhat startling development and one that will most certainly increase the market impact of a Black Box Warning dramatically. 

Black Box Warnings have been flying off the shelves since the confluence of events during 2004 that made it appear that FDA was not doing its very best work.  However, they are attached to products to make people feel as if risk management steps are being taken, despite the fact that there are no data to support their use as a risk management tool.  This is despite the fact that the agency is supposed to be evidence-based in its decision making (it usually is, it is not always, and certainly has failed to be lately). 

The CMS decision is a bad one.  Some drugs have Black Box Warnings placed on them because of a signal in animal studies.  Forteo, an osteoporosis treatment that actually replaces bone mass, has a Black Box Warning because of a signal seen in animal studies regarding osteosarcoma.  If Medicare Part D formularies are able to withdraw a drug on that basis, a very important drug for treatment of a very devastating disease may not be available to a large swath of the elderly for whom it was intended.  Surely that is not the intent, but nevertheless, it could be the effect.