FDA Chief Counsel Stymies Heparin Probe
3 CommentsBy Ed Silverman // April 30th, 2008 // 6:21 pm
A House investigator charged that the FDA’s Office of Chief Counsel has undermined a congressional drug safety investigation, InsideHealthPolicy* reports.
Energy and Commerce Committee investigator David Nelson told a bipartisan committee the probe was stymied because the FDA office denied investigators access to documents and personnel, the web site wrote. Committee investigators interviewed operational and field staff at FDA - who were involved in heparin inspections and scientific analyses - but not agency lawyers involved in policy decisions, according to InsideHealthPolicy.
“We’ve not gotten interviews with the counselors that make many of these decisions or at least have veto authority over those decisions,” Nelson told the committee.
Nelson also told the House panel that the contamination could have been averted if the FDA inspected the Chinese plant. Baxter sent one person who spent one day in the plant, but five months later, the agency discovered numerous problems. “It really is impossible for a plant to have fallen that far out of compliance in five months,” he testified, according to The New York Times.
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Lisa Van S
Daivid Nelson,.. Go Get’m… Kick Ass!!…..
Jack2
Was it “falling out of compliance” or was it intentional contamination? A contaminant so devious, that it took the FDA and Baxter weeks to find AFTER they KNEW to look for a problem.
James
I’m fascinated by the China manufacturing situation.
Pet food was contaminated with melamine. Doesn’t naturally occur in pet food, no reason for it to be in the same plant, and just happens to help cut costs and escapes inspector’s notice.
Same is true for the contaminant found in the offending heparin.
Read an NYT article that indicates, amongst other issues, some Chinese dumpling manufacturers treat cardboard with chemicals to give it the appearance of meat or veg filling.
There seems to be a pattern and acceptance of fraudulently using dangerous fillers in place of food and drugs in China. Combine this with lax FDA oversight, and nowhere near the resources to ensure sufficient compliance with GMPs, and we have a ticking time bomb.
I wonder how many APIs have been replaced with useless, but not dangerous, ingredients, and how long it will be before those, if ever, are discovered. As one of my friends from China stated, it is the “wild wild East.”
We are playing a game of Russian Roulette with a Chinese gun. We are only now stationing FDA inspectors there on a permanent basis. Unless and until we can assure GMP compliance (as long as that is the bar), we should have country of origin labeling.