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The Wall Street Journal reports that Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research is being investigated by the inspector general. The ethics complaint was filed by Amphastar Pharmaceuticals and comes to light during their six year quest for approval of a generic form of Lovenox, a multi million dollar blood thinner. They are saying that their competitor has “special access” to Dr. Woodcock, and that Dr. Woodcock even co-authored a paper with scientists from the competition, Momenta Pharmaceuticals Inc.
They are asking that she rescue herself from the matter.
This surrounds the tainted Heparin incident. Dr. Woodcock co-authored the paper that addressed the sources of the Chinese tainted Heparin and won kudos’ for Momenta. Interestingly, although the FDA didn’t find any contamination in the Amphastar version, Amphastar did find out that the Chinese had misled them as to the origins of the raw material used to produce it.
Momenta is teaming up with Novartis to market the drug. Novartis has it’s own generic company, Sandoz.
It seems to me, that if anyone were being completely ethically fair, Dr. Woodcock would have also included the scientist from Amphastar in the paper. Anyone who makes Heparin should have been brought into the “fold” precisely to assure everyone that all measures, I mean ALL measures to ensure the general public safety were being addressed. This has to be extended to generic drugs as much as it is for brand name drugs. What’s fair, is fair....
Thursday, August 13, 2009
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Former, I would love to believe that all measures are taken to ensure public health and safety for all drugs. However, the FDA preamble and pharma went to extremes to accomplish just the opposite. How do we ever trust again?
ReplyDeleteWhat's interesting about this case is that it is company versus company. Normally, at least in discussions here, when we hear that a company wants an FDA official to recuse, it is because that person is alleged to be "biased" against the drug for whatever reason. In this case, the accusation is that Janet Woodcock is "playing favorites" with one of the companies.
ReplyDeleteOf course, the fact that it is Janet Woodcock also makes it "a story," since she has been so central at FDA for so long.
And a part of the story that hasn't gotten much press -
ReplyDeleteThis from AP
WASHINGTON — The head of the Food and Drug Administration's medical device division announced Tuesday he will step down, months after scientists under his leadership alleged they were pressured to approve certain products.