As pharmaceutical marketing researchers, we must be mindful that the federal government is not only involved in the regulation of the drug industry, but the 50 state governments are as well. Moreover, individual states have significant autonomy in determining what regulations to employ, do not seem to be coordinating in any meaningful way their regulatory activities, can change the rules on a dime and still expect everybody to be aware of, and comply with, their regulations.
Take, for example, legislation passed in January by the District of Columbia that requires licensing of any person who steps foot into the district to sell pharmaceutical products. This legislation requires that pharmaceutical sales reps have a bachelor’s degree, that they submit a notarized affidavit that they will comply with the Board of Pharmacy’s Code of Ethics, that they pay a $250 fee for the license and be fined up to $10,000 if they violate any element of the law.
What does this have to do with marketing researchers? Lots. Some states have proposed to make it illegal to give gifts or compensation to docs who serve on formulary committees. Does a marketing research honorarium fall into this category? The state gets to decide.
Here is about the only thing that is clear. States are taking an increasing interest in activities related to the marketing of Rx products, and are willing to fine anyone who violates one of the laws being created every day.
Someone should take the opportunity to provide those of us in this business with a guidebook, updated regularly. As if it hasn’t been tough enough to keep track of the FDA, we now have the equivalent of 50 little FDAs, without the sophistication and history of their federal counterpart, drafting regulations. We’d better pay attention.
Richard Vanderveer is group CEO, GfK US Healthcare Companies
From the July 01, 2008 Issue of MM+M - Medical Marketing and Media
