Earlier this year, I offended some when I wrote a story about Abbott Labs paying $1.5 billion to settle a Department of Justice investigation into off-label promotion.
I wrote that off-label promotion was “apparently second nature” to device manufacturers and infuriated those who felt I was painting with too broad a brush and offering an opinion when none was needed. Yet, my conclusions were drawn from a Department of Justice official in Minnesota.
Turns out my characterization about that illegal practice wasn’t far from the truth.
In a fascinating, investigative piece about how off-label marketing of a bone cement product landed Synthes executives in prison after patients died, Fortune magazine writer Mina Kimes described off-label marketing like this:
Off-label marketing is so common among drug and device makers that it’s often dismissed as the equivalent of driving slightly over the speed limit.
The article, cleverly titled “Bad to the Bone: A Medical Horror Story” provides not just a detailed insight into one instance of corporate malfeasance, but also demonstrates why there is deep suspicion about the practices of all medical device companies.
The case offers a rare, sometimes disturbing, glimpse inside the shrouded world of medical devices, where surgeons occasionally turn for advice during operations to twentysomething sales representatives.
“Shrouded” jumps out at me. No wonder laws aiming to provide greater visibility into the relationship between physicians and device and drug makers have to be named “Physician Payment Sunshine Act” (emphasis added).
The immediate implication is that not all is right and above board. And perhaps the suspicion is not misplaced given that doctors are sometimes — rightly or wrongly — deferring to salespeople who work on commission.
That issue of how sales reps are compensated made an entrance when an unusual element was introduced in the corporate integrity agreement involving GSK and its historic $3 billion settlement with the Department of Justice. That document specifically called for not compensating sales reps based on their sales in specific geographic territories.
All of which leads me to wonder whether it’s time to change the sales structures of drug and device marketers and reps. Change has occurred in physician/vendor relationships before. Gone are the days when drug and device makers would fly doctors to exotic locales in the name of continuing medical education.
Maybe automatic off-label promotions will one day become as abhorred and lead to a fundamental change in sales and marketing tactics and compensation. It’s necessary if not for the sake of patient safety and corporate integrity, maybe for purely selfish financial reasons.
While off-label promotion is far too pervasive, and is often unethical in addition to being always illegal, FDA plays a key negative role in this drama by often drawing the definition of approved indications for use too narrowly in many cases. It is clear that there is substantial clinical justification for limiting the approval of the Synthes to distal radial fractures and not extending it to use in the spine. However, some times the indications for use are driven by regulatory precedent, 3rd party lobbying, and internal bureaucratic procedures and have no substantial clinical justification. The overuse of labeling restrictions by FDA often leads to surgeons and physicians to ignore the cleared label claims of devices.
Re-establishing the utility of labeling information in many cases will take more than a simplisitic reliance on criminal and civil penalties to enforce the current labeling practices. FDA needs to bring its labeling practices up-to-date and to provide more relevant information.