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.
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.