Thursday, January 29, 2009


Have Some Preemption with Your Sunshine!

FDA Law Blog has a very interesting post today about the Physician Payments Sunshine Act, version 2009. Like an earlier version, this bill would set federal standards for the disclosure of gifts from pharma to docs in their various roles as consultants, etc.. Unlike the earlier version, there is a preemption provision here which would bar individual states from imposing their own, different such requirements.

Can anyone spell, "Massachusetts"? OK, we'll make it easier, "Vermont"?

Once again, the "patchwork" of standards argument was used to justify preemption in this instance. Relative to FDA preemption, this is small potatoes in my view. But there it is. I can see how, for example, if Company A wanted to pay Doc B 10K for a few minutes' time, they might not want to set him up in Reno for a few days to do so.

Here is the relevant passage:

"Unlike the 2007 version, the 2009 legislation includes language, effective January 1, 2010, pre-empting state laws that require reporting of payments or other transfers of value to physicians. However, the bill would not preempt state requirements for reporting of information not required under the bill.

Federal preemption was an important to concession to industry. As stated by AdvaMed in its press release: “[I]t is important that any federal disclosure legislation create a uniform national standard to prevent a patchwork approach by all 50 states.”

Perhaps it is good that "chaos" has become "patchwork." Eventually, it may evolve into "mosaic" or even "tableau." And, from there, to "federalism."

Alternatively, some day we might be able to get a national driver's license and never have to deal with our local state office again. Preemption we should live with? Compare waiting on line at the post office and at your state motor vehicle department.

Deal or no deal?



  1. Hmm the UNITED States of America?

    Here's a little history refresher:
    on March 4, 1789, when the American people replaced the confederation type government of the Articles with a federation type government of the CONSTITUTION. The new government reflected a radical break from the normative governmental structures of the time, favoring representative, elective government with a weak executive, rather than the existing monarchical structures common within the western traditions of the time. The system of republicanism borrowed heavily from the Enlightenment ideas and classical western philosophy: a primacy was placed upon individual liberty and upon constraining the power of government through a system of separation of powers.

    For those who want a brief overview of "separation of powers":
    Separation of powers, a term ascribed to French Enlightenment political philosopher Baron de Montesquieu,[1][2] is a model for the governance of democratic states, having its origins in an ancient idea of mixed government. The model is also known as trias politica. The model was first developed in ancient Greece and came into widespread use by the Roman Republic as part of the uncodified Constitution of the Roman Republic. Under this model, the state is divided into branches or estates, each with separate and independent powers and areas of responsibility. The normal division of estates is into an executive, a legislature, and a judiciary.

  2. Thanks, Former. I suppose we can all be grateful that the concept was not a "patchwork of powers" or a "melange of mightitude."

    In any event, federalism generally refers to the division between core and periphery - central gov. and states - rather than the separation of powers re: the three branches at the top.

    But, either way, it is probably a feint on both sides. Anti-preemptors are rarely hard-core about states' rights. The real issue is not between the feds and the states but about special interests, whom the center may patronize (and vice versa), and wider, public interests which, for these citizens, are being expropriated in the interest....of those interests.

  3. It looks to me that the feds would be setting the baseline, or minimum, for reporting much in the same way that FDA used to be considered. Nothing in the bill prevents states from asking for more information than what the feds will require. And the bill provides for enforcement, which few of the state regs do. California, to my knowledge, was the first state to require disclosure, but never provided for enforcement. Preemption, in this particular case, will certainly make my life much easier.

  4. Harpster - I think "uniform national standard" means that. There is room for states to regulate outside whatever isn't specified - like whether the company gave the KOL a hug along with a check (presuming hugs are not specifically accounted for in the regulations). But I doubt there will be many "loose ends."


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