Janet Woodcock, director of FDA's Center for Drug Evaluation and Research, is under investigation by the Department of Health and Human Services' inspector general for an alleged conflict of interest, reports the Wall Street Journal. Amphastar Pharmaceuticals and Momenta Pharmaceuticals are both trying to get FDA approval of a generic blood thinner, and in an ethics complaint, Amphastar says that Momenta had special access to Woodcock as she co-authored a paper with scientists from Momenta and did not recuse herself from the approval process. The paper identified the source of the contaminated heparin imports from China.
Also at FDA, the head of the medical device division, Daniel Schultz, is resigning, the Journal's Health Blog adds. Some of Schultz's decisions were the focus of hearings held by Senator Chuck Grassley (R-Iowa) as they were made over the objections of reviewers and scientists at FDA and tended to favor industry over science, according to Grassley. Schultz is leaving "by mutual agreement" with Commissioner Margaret Hamburg.