Day One

at the Health Law Institute was OK. Tomorrow looks more promising.

I had lunch with a woman working for a law firm which has some Big Pharma clients. She posed an interesting question to me, and I responded in kind.

Her client was asking about employees who have licenses as practitioners, who need to log some clinical time to keep their licenses. Some of these nurse practitioners are also sales reps, whose pay is structured on how practitioners in their geographic areas prescribe. What should be done about these nurse practitioners, whose prescriptions could theoretically affect their pay? Would this arrangement violate some kind of anti-kickback statute?

Well, Stark is not a consideration, since they are not physicians. But there may be state regs that mimic Stark, but apply to a wider array of prescribers. An obvious recommendation to the client would be to restructure their pay for the period when they are in the clinic. Fascinating question though. I'd love to know what they eventually do.

I posed a question back to my lunch friend. If a clinical nurse educator is hired to address an interest group like an Alzheimers association, and they are required to discuss only the disease state and not their employer's medication, how might they still violate the Pharma code by inappropriate promotion? Well, the answer may lie in the clinical development strategy the company pursues, through line extensions and sNDA applications.

Did you ever compare labels and indications between two or more drugs in the same therapeutic family, which are fundamentally identical in mode of action. Go ahead - look it up with the statins, for example. PB will wait.

OK, you back? The clinical strategy for these compounds has been geared toward creating something unique in their indications that the other compounds haven't got. So, when nurse educator Betty speaks to a bunch of cardiologists about lipid-lowering strategies, and discusses the need for the patient to reach certain benchmarks in their therapy, wouldn't it be convenient if her company's compound happens to be the only one indicated to reach those benchmarks? She never needs to mention the drug name, as long as she pounds the message about the therapeutic end-points repeatedly. Then the sales reps for the attending docs can follow-up with a visit sometime later.