White House Drug Importation/PhRMA Deal Scandal Thickens with New Contradictions...

by: David Sirota

Fri Dec 18, 2009 at 16:50


NOTE: For background on this scandal, see this and this previous post.

TPM has a new story up about the now-thickening drug importation scandal - and the explanations are starting to get more and more convoluted and contradictory as the White House works to fight off the accusation that its political staff actually wrote an FDA safety-warning letter:

Hearing rumors of an FDA letter opposing his amendment last week, Dorgan called Hamburg to inquire about that matter. She told him that she didn't know of any letter. Then, just 24 hours later, on Dec. 8, the letter went out, signed by Hamburg...

Asked about Dorgan's timeline by TPMmuckraker, FDA spokesperson Meghan Scott did not say it was inaccurate. "The Commissioner did speak to Sen. Dorgan in the days before the letter was sent," Scott says. "On that call, she expressed the FDA's concerns, but at the time, no decision had been made on whether or not to send a letter."

Scott adds that the letter was sent in response to an inquiry by Sens. Sam Brownback (R-KS) and Tom Carper (D-DE). And she argues that the letter is consistent with the FDA's past position on drug importation.

First the contradiction: According to this report and the Wall Street Journal report, FDA Commissioner Hamburg "didn't know of any letter." The FDA spokesperson does not deny this - but suggests that when Dorgan talked to the FDA Commissioner a letter was under consideration. Notice the phrase "at the time, no decision had been made on whether or not to send a letter" - the idea being that there was the possibility of a letter, it was just under consideration.

One of three things is going on here: Either 1) the FDA Commissioner straight-up lied to Dorgan and there really was a letter being planned 2) A letter was being planned, but Hamburg had no idea about it, which is why she said she "didn't know of any letter" (this possibility would suggest she's completely incompetent) or 3) there was no letter planned, but the White House political staff wrote one in 24 hours and forced Hamburg to sign it to help them kill importation and preserve their secret PhRMA deal.

Before trying to deduce which of these is most likely, first consider the dishonesty of the FDA's current claim that "the letter is consistent with the FDA's past position on drug importation." The FDA, of course, simultaneously says that the manufacturer-imported drugs that Americans consume every year - about 40 percent of all pharmaceuticals sold in the country - are completely safe. But getting beyond that, is it even true that simultaneously claiming wholesale/pharmacist-imported drugs would be unsafe is "consistent with the FDA's past position"? Well, no. Not at all, considering FDA congressional testimony just a few years ago.

David Sirota :: White House Drug Importation/PhRMA Deal Scandal Thickens with New Contradictions...
Here's an excerpt of a House hearing with FDA Commissioner Lester Crawford on 3/11/04 - Rep. Ray LaHood asks Crawford about the House's then-recent passage of the same legislation that Dorgan introduced last week:

LAHOOD: I'm asking you if you agreed with what the House of Representatives did with respect to re-importation. I'm asking you for your opinion on that.

CRAWFORD: My opinion is, is that we would modify it to make it a little more consistent with the fact that we can monitor these more carefully to make sure they're safe, and that we've got the resources to do that, which would cost, we believe, maybe as much as $58 million in additional resources...it's a qualified yes.

So the FDA in 2004 said importation actually could be done safely with a tiny amount of resources - $58 million to be exact (and Obama's February FDA budget reflected this request for new resources for importation). Later in the same hearing, in fact, Crawford went on to say that current law barring individuals, pharmacists and wholesalers from buying lower-priced medicines from other industrialized countries is "a system that's crying out for some reform." And he agreed with Republican Rep. Jo Ann Emerson when she expounded on "Europe's history of parallel importation, which I think has been going on for about 30 years there" and which "statistics show that that system has had no counterfeit problems, but it obviously has led to competition within the European market -- competition with prices that the government charges."

So for the Obama FDA to now say opposing importation "is consistent with the FDA's past position on drug importation" is simply not true. It's not consistent - not at all.

So that gets us back to what's really going on here. I'm going to discount the idea that Hamburg just lied to Dorgan - what motive could she have? If she wanted the bill killed because she was genuinely worried about its safety implications, she would have told him she was planning a safety warning so as to get him to not even introduce the bill. Sure, I guess it's possible a letter was being planned by Hamburg's underlings and that she didn't know about it, but that seems completely implausible - it's a huge issue and of huge importance to the FDA.

So we're back to number 3. If I had to guess, I'd guess there was probably no letter planned when Dorgan talked to Hamburg because the FDA had previously - and rightly - considered importation a safe proposition. But the White House political staff wrote one in 24 hours and forced Hamburg to sign it. That politicization of science and safety agencies - a letter on FDA letterhead sounding the safety alarm - would have been a perfect way to help them kill importation and preserve their secret PhRMA deal...precisely the outcome that happened.


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What did Obama do on importation January thru November? (4.00 / 1)
The issue of WH pressure on the FDA is clearly in safe hands.

I'm rather more concerned with the substantive issue:

  1. We know Obama promised as candidate to allow importation if it could be done safely.
  2. In your earlier piece, you said that importation would was already permitted under existing legislation - provided HHS certified that it was safe.

  3. In this piece, you quote Bush's FDA honcho basically supporting importation.

Why, therefore, has it taken 10 months of Prez Obama for the question to hit the headlines?

Why weren't the AARP, consumer groups, labor unions and the like banging on doors in January demanding at the very least a timetable for implementation of importation?

Together with the screwy way that loads of Dem senators have shifted sides on importation over recent years (my earlier piece), it just confirms in my mind that there is much more to come on this.


Plus... (0.00 / 0)
If you're right and importation can start without new legislation. why the Sam Hill did Dorgan move his amendment and everyone else (including the WH) act as if it was a big deal?

[ Parent ]
Because... (4.00 / 2)
Instead of leaving it up to the discretion of HHS, it would force them to do it right now.

[ Parent ]
Yes, but... (0.00 / 0)
I can see the point of replacing existing unsatisfactory legislation with a clean text which as far as possible eliminates the ability of the executive to impose spurious restraints on importation.

What I'm not clear on is why, in the meantime, the administration has not been facilitating importation under the existing law.

According to this from AP on December 9,

As evidence of Obama's continued backing, Linda Douglass, spokeswoman for the White House Office of Health Reform, cited $5 million he proposed in his 2010 budget for the FDA to develop import policies. She said the agency will continue working on ways "to create a pathway to importing safe and effective drugs."

Not much sense of urgency or commitment there; not much moolah either; but the implication that the FDA has at least started 'working on ways'.

I'm not clear whether there's been any coordination between the WH/FDA and Congress on importation; presumably Dorgan had conversations on importation with WH/FDA before his famous chat with Hamburg, if only just vaguely to see what was cooking.

Not to mention where the WH/Pharma deal fits in to all this  - I'm sure I read somewhere early a pharma guy saying that the deal did not cover importation, but can't trace the source.


[ Parent ]
And on a related note... (0.00 / 0)
Hagiography takes a hiatus from Daily Kos (warning: lots of super hi-res photos):

End of the road. One last photo-diary (and a personal thanks)

I mention this because I find it interesting that with the senate all but wrapping up its popsicle on a stick health care "reform" bill any day now, and not just the left but country erupting in howls of anger over it, one of Obama's biggest cheerleaders, almost all of it based on cool-looking images and other forms of mythologizing, has decided to call it quits on the biggest progressive blog in the country. Could someone's "work" be done?

Yeah, I think he/she is a plant. As are others. Obama is now a brand, and does its "marketing" via ALL available venues, including and perhaps especially through stealth ones such as astroturfing on blogs. Pretty pictures can go a long way...up to a point.

"Those who stand for nothing fall for anything...Mankind are forever destined to be the dupes of bold & cunning imposture" -- Alexander Hamilton


Kind of a shady accusation... (0.00 / 0)
With little proof provided supporting it.  I mean by that rationale I could accuse you of being a Republican plant here to undermine support for Obama on a leftist blog.    And given your many negative comments on Obama, there McCarthy type circumstancial evidence to support that (for the record I do NOT think this of Kovie and am merely using it as an example).   I have seen several of those images used across the internet and a few in national print publications.   Hi-Res photos of Obama are all over the internet, a simple google search comes up with a ton.    He is the President after all.  

I agree, there is a chance he is a plant, but one could make a logical argument that with support slipping he'd be all the more likely to need a plant.   Furthermore, I think a plant would be web savvy enough to know that huge ass images like that don't work well on the web and free hosting sites don't like them much as can be seen by some not showing up, but that's just one logical deduction and certainly not evidence either way.    Pics like that can be found online, he could work or be an intern for a media outlet with those kind of resources.   My feeling is he is a young 18-22 year old with Hero worship and much like a tween displays pictures of the pop culture flavor of the day, he is doing so with Obama.   I just don't see the White House using a plant.    There is little need to do so, since there are many people who do have a strong love of the President.    Besides, it wouldn't be too difficult to find the person and figure out where he is posting from and who he is...    Clearly based on the comments section, He got his ass torn up on a diary and decided to leave... something I could easily see a kid doing.


[ Parent ]
And YOU could be (0.00 / 0)
a "plant" for the DNC or DLC!

[ Parent ]
... (0.00 / 0)
1) Was there really a secret deal with the drug companies?  By that i mean, there has been talk of an agreement reached for months.   By that very notion, I don't know its secret.  Splitting hairs I know, but still I hate seeing inaccurate information.

2)   I keep seeing some people in the comments sections suggesting something illegal.   While certainly immoral and unethical if the WH did do this, I fail to see what would be illegal.   Can someone show what is illegal about?   Again, not saying it was RIGHT, just saying I don't see what's illegal.  


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