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....