While this topic is specific to the United States, I wanted to share a new legislation with you, which went into effect a few weeks ago in Washington, D.C. and may follow to other states…
The legislation called the Safe Rx Act will require the licensure and continuing eduction of pharmaceutical representatives in the DC area (at a yearly cost of $250 or more according to some sourced) and will also prohibit them from providing knowingly false information to physicians (this means off label). In addition to regulating detailers, SafeRx creates an academic detailing program to educate doctors on the latest developments in pharmaceutical research (probably paid for by the dollars earned from rep licensure). Finally, the bill prohibits members of the District’s Medical Advisory Committees from receiving gifts from pharmaceutical companies.
While I am not sure what the implications will be for the Medical Science Teams in the DC area (will they too be part of this legislation and require the same licensure, etc.?), there are implications to interactions with national, regional and local opinion leader specifically related to engaging those involved in the District’s medical advisory committees in fee-based activities such as Ad Boards, Speaker Programs, and the like. As such, it is important for Pharmaceutical companies (particularly Sales, Marketing and Medical teams) to start building their 360-degree knowledge of key opinion leaders through continuously updated profiles that include information on recent board memberships and much more! This will become even more compelling as more and more states jump on the band-wagon…and continue to refine what Pharma can and cannot do.
What implications do you feel this will have on pharma's sales and marketing models? How are Sales, Medical and Marketing teams going to be able to build and manage this 360 degree knowledge of KOLs? I would be interested in your comments.
Susan Dorfman
VP Global Marketing
Skila
www.skila.com
What are the implications?
Very interesting and at the outset, it appears a good idea if indeed it improves the industry's reputation and physician's willingness to communicate with reps. However I wouldn't be surprised if governments were accused of some kind of stealth tax for an already-burdened pharma industry - particularly if good-natured companies are already following many of the laws anyway.
And if it gets to any larger scale (beyond D.C.), any regional, national or international strategy-makers would presumably need to learn the exams too?
I'd be interested to know whether people in pharma companies think this legislation is a good idea or not? And what the cost implications might be for them?
Effects to be Felt...
Paul, it is very interesting in deed, and the implications for Pharma are many and will greatly depend on how many states jump on the bandwagon, and how other legislations will be coupled with one like this. Currently, this legislation (as it pertains to pharma) focuses on licensure for detailers, bans certain thought leaders from accepting financial incentives of any kind from pharma, and prevents detailers from discussing off label use of their products. It originally had a clause to ban data mining, which was eliminated in the final signed version...but I bet you this will certainly be something of focus in the near future.
What will all this mean to sales and marketing, particularly as the FDA approves the use of reprints that address off-label use for products (besides confusion)? I have my view point and it is certainly not in our (Pharma's) favor as I look at pending and new legislations that touch on Pharma's marketing practices. I would like to hear what others think!
S