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by Mark S. Senak
Eye On FDA



Each year, the National Conference on State Legislatures puts out annual numbers on what is going on at the state level in terms of healthcare legislation. According to the 2005 and 2006 Prescription Drug State Legislative Reports, there were between 500-600 different bills introduced at the state level affecting prescription drugs. Accordingly, I thought it would be a good idea to look at a few of the trends in this area.

For example, on the issue of marketing and advertising, there was a great deal of activity. While in 2004 there were only 13 states with marketing and advertising legislation proposed, in 2005 there were 28 such states and in 2006 there were 22. While that 2006 dropoff might indicate a decline in activity, in fact in 2005 only one such bill passed, but in 2006, 4 passed. According to the NCSL, one of the primary motivators for states to move in this area is to seek to curb pharmaceutical costs. Some of the proposed bills were far-reaching. For example, in California it was proposed that any drug that has been promoted in direct-to-consumer advertising could not be put onto the Medi-Cal contract drug list. Others would require companies to reveal how much they were spending in the marketing of drugs while still others sought to curb the use of prescribing information in the marketing of drugs.

In addition, legislation that would impact the way pharmaceutical benefit managers (PBMs) operate was considered by 15 states in 2005 with 6 bills passing, but that nearly doubled to 28 in 2006 with only 2 bills passing. Examples include efforts in Colorado to require PMS to disclose any conflicts of interest they might have to a covered entity and would prohibit a PBM from requiring a pharmacist to participate in one contract as a pre-requisite to participating in another. Periodic audits would also be required. In fact, disclosure and transparency were often the themes of this legislation through the establishment of key standards.

And respecting pricing, in 2005 there were 29 bills with 9 passing, and in 2006 there were 24 bills with 5 passing. Pricing proposals included Florida efforts to require the collection of data on retail prices for the 100 most frequently used prescriptions while others sought to make illegal pricing practices considered excessive.

For 2007, while there is no set report, my feeling is that there is an even greater concentration on marketing practices as a way to control costs, targeting issues such as gift-giving and use of prescribing information by sales representative.

While the Congress is most often the focal point for issues related to the regulation of pharmaceuticals, there is a growing activism by states across many fronts, including healthcare. And it is clear that if there is enough momentum in state capitols, then even without federal action, policy can be changed.


Source: EyeOnFDA.com



RELATED READING:
- State Healthcare & Pharmaceutical Legislature Roundup
- State Update on HPV Vaccine Mandates
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