President elect Obama has already stated that his administration would take another look at reimportation. While it has been publicly stated that this is due to Chinese and Indian drug and food safety issues, Vice-President Elect Biden chairs a Senate Judiciary subcommittee on Crime and Drugs, so he is well versed and knowledgeable about the dangers of unfit drug dispenses.

People need to realize that shipping and handling of perishable products is time and temperature sensitive. When done according to compliance standards (ie. keeping it legal) these variables often add considerably to distribution and end product cost. The only way around this is by extending the amount of time in shipping channels, cutting corners on packaging and/or otherwise increasing logistics issues and/or risk. Once you start thinking about it, the idea that you can save money by increasing distribution costs and the rate of damaged goods doesn’t make as much sense. Reimportation is also more carbon intensive (i.e. not as ‘green’); may allow for US security breaches; increases risk and hence insurance costs; and would likely cost the US more jobs b/c it would likely hasten outsourcing including the outsourcing of distribution jobs (especially Ohio, Pennsylvania, and CA). The new adminstration and congress also need to take a closer look at the potential negative ramifications of insurance company and taxpayer funded program subrogation clauses. The cumulative end costs when you include the medical, litigation and political costs might be higher than the projected savings.

I think that even if it’s passed that Pharma will simply raise prices elsewhere and limit supplies.

It’s a great vehicle for politicians though and if Pharma wanted to have a pseudo-advisary in Congress this would be a way to do it.

“So we don’t think we’ll be seeing prescription drug litigation vanishing from the face of the earth any time soon.

But we’ll keep trying.”

So it comes down to which face of the earth one hopes for.

Personally, although I am against preemption, I always thought the Levine case was a “stretch” at best. That is part of why the preemption folks via the Solcitor General got it to the Court in the first place. The particular circumstances here may be as close as one can find to a “good” argument for preemption. It is not typical of cases in which the doctrine would evoke, for many people, outrage (which, again, was the point for pro-preemptors of this case being the poster child. You don’t want poster children to outrage too many people).

Read Drug and Device Law’s reflections on the case. They anticipate a decision that will be a “beachhead” in their overall battle. Their ultimate goal is also clear and stated directly at the end of the blog - the disappearance of lawsuits over ‘failure to warn’ in the context of FDA-approved drugs. That is, broadest possible preemption.

We in Michigan have lived under such a law for thirteen years. It ain’t pretty.

One additional point…I believe that both of Emananuel’s statements occurred before the series of food, drug (eg, heparin) and toys safety issues Importation legislation that doesn’t include some sort of certification by the HHS Secretary will be much harder to pass now.

Atlex

Good point. I posted this only because I thought the tone, not just the particular subject, was interesting.

Cheers
ed

So, from my perspective, we have a long way to go to know what sort of stances the new administration will take on issues we often discuss here - FDA reform, preemption, et. al..