April 24, 2008
Dingell buries von Eschenbach: "I didn't fall off the cabbage wagon yesterday."
The RPM Report states:
There’s no love lost between Rep. John Dingell and FDA Commissioner Andrew von Eschenbach. That tenuous relationship—and a little congressional theatrics—were on display during the Energy & Commerce hearing into FDA’s overseas drug inspections process....The Michigan Democrat took issue with FDA commissioner Andrew von Eschenbach’s broad plan to overhaul the agency’s overseas drug inspection structure to avoid another heparin situation during an E&C Oversight and Investigations Subcommittee hearing. Von Eschenbach was trying to explain that it’s not just the number and frequency of inspections by inspectors, but how the inspections are carried out that matter.
Dingell was having none of what he called the commissioner’s “toe dancing.” Dingell, during his allotted time for question-and-answer, asked von Eschenbach to answer “yes” or “no” to a series of questions. The commissioner started off obliging Dingell but then began getting off track with longer, more verbose answers. ...Dingell: “I didn’t fall off the cabbage wagon yesterday. I’ve been talking to food and drug commissioners for 40 years. And you’re not the first fella I’ve had to skin for not doing his job and coming up here and defending an indefensible situation. I want to maintain my respect for you but I can’t maintain my respect for you if you keep toe dancing around the hard facts that curse you with the inability to do your job because you don’t have resources.”
Ok, I understand the heat between FDA and Rep. Dingell. But I don't understand, where is the heat directed at Baxter?
Isn't it Baxter's fault for not checking its suppliers more thoroughly and providing them sensitive equipment to test for impurities? It sounds like some quality inspector at Baxter wasn't doing their job... Baxter clearly has resources, FDA clearly does not. FDA should still fine Baxter regardless of whether the impurity was found in New Jersey or an overseas plant. Baxter has final responsibility for the quality of the drug they send to hospitals worldwide, not the Chinese authorities. Am I missing something??
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