Chief Of Staff Rahm Emanuel: A Friend To Pharma?
8 CommentsBy Ed Silverman // November 7th, 2008 // 10:52 am
Now that the Democratic Congressman from Illinois has accepted the job of chief staff to President-elect Barack Obama, we thought we should share with you some of his remarks about the pharmaceutical industry over the past few years. Specifically, he railed against pharma over the issue of reimportation on a couple of occasions…
In September 2004, he had this to say: “…It’s not just politicians standing around and talking about why we need importation. How many studies do we need to show that the American people are convinced that drugs are too expensive in this country and committed to doing something about it?..The pharmaceutical industry and Congressional Leadership continue to hide behind the facade of safety concerns, while Americans continue go without the drugs they need.”
And in June 2007, a few months after introducing the Pharmaceutical Market Access and Drug Safety Act (HR 380), he said this: “For too long the Congress has let the pharmaceutical industry stand in the way of keeping safe and affordable prescription drugs out of the hands of the consumers. With this bipartisan legislation, we can help the American consumers benefit from a truly open and competitive marketplace.”
Hat tip to Peter Rost blog
Justice in MI
As we know, the reimportation issue has mostly slipped off the radar, partly because of the success of Part D and the expanded use of generics. And, of course, McCain was equally insistent on this issue at the time.
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..
Ed Silverman
Hi Justice,
Good point. I posted this only because I thought the tone, not just the particular subject, was interesting.
Cheers
ed
Wavefunction
Hi Pharmalot…sorry this is off topic but I was quite interested in knowing what your opinion was about this recent Op-Ed where the NYT thinks that’s it’s Wyeth’s fault for not warning physicians about the correct administration route for a drug:
http://www.nytimes.com/2008/11/07/opinion/07fri1.html
atlex
Ed and JiM,
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
Justice in MI
Wave = Holy cow! I don’t think this is the place to start yet another preemption discussion, but if you search the site - under Levine, preemption, etc. - you will find no shortage of views, some of which echo today’s NYT editorial and some of which do not.
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.
Justice in MI
Here are the relevant last two sentences of the DDL entry:
“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.
FDAer
Personally I was against reimportation. I had thought the arguments against it were valid and still do but now think that Pharma’s outsourcing to China and India and the lack of inspections and FDAs ‘Quality by Design’ initiative are much more dangerous than reimportation.
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.
Anne PME
Outsourcing to China and India and reimportation are tied together. Separately and cumulatively, both lead to higher rates of unfit dispenses. Prescription drugs and devices are perishable. The longer the time that a drug or device is in holding and the less developed (and/or less secure) the manufacturing and/or distribution channels, the higher the rate of damaged (i.e. adulterated/substandard) perishable goods.
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.