Lilly to Massachusetts legislators: your new code stinks
You might have caught Pharmalot’s piece on the recently passed Mass. legislation that will codify pharmaceutical marketing to healthcare practitioners. The article describes Lilly CEO John Lechleiter’s response to the measure, which was harsh, essentially threatening to caught off Mass. from future Lilly R&D investments:
Such work is the backbone of research and development in biotechnology and pharmaceuticals. And it’s about to get a whole lot more difficult in this state, which almost certainly means that less of this important work will take place here in the future.
That can’t be welcome news to Mass. legislators who have been trying to lure new private biotech investments and retain existing firms by supporting them with large public investments.
Lechleiter’s response had me thinking: “What’s so bad about the new law anyhow? Isn’t it just codification of PhRMA’s own code?” The answer, it turns out, is not so much in the codes as in how they are enforced (or not).
To get everyone on the same page, I’ve created PDFs of the PhRMA code, the relevant part of the Mass. legislation, and a table that compares and contrasts the two.
What you’ll read in the comparison table is that most of the legislation is very similar to the PhRMA code, with the only substantive differences found in rules proscribing the provision of meals. Essentially, PhRMA’s code provides for more circumstances where modestly priced meals are allowed to be provided at no cost to practitioner-consultants and CME attendees.
The major difference comes with the monitoring and enforcement provisions of the Mass. law. Mass. wants to put huge muscle behind the PhRMA rules, requiring sponsors not only to follow the rules but also to demonstrate in great detail to Mass. law enforcement that they are following the rules. Mass. accomplishes this via a morass of new monitoring and reporting requirements on the sponsor side and severe financial penalties for individuals who do not comply. PhRMA’s code is strictly voluntary and has no monitoring or enforcement provisions.
My thinking now? I’m not surprised by the Mass. law. This is what happens to an industry when it earns a reputation for conflicts of interest and outright deceptive marketing that endanger public welfare and cost taxpayers money. I’m also not surprised by Lilly’s response. The law creates an unwieldy compliance burden that could become nearly unmanageable and very costly if its proliferates beyond the Bay State. Lilly is out in front implying to other legislations they had better think twice before passing such laws.
So now we know.
October 28th, 2008 at 9:29 pm
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