FDA Drug Chief Under Investigation

The inspector general’s office of the Department of Health & Human Services is reportedly investigating a conflict-of-interest charge involving Janet Woodcock, director of FDA’s Center for Drug Evaluation & Research. The investigation was prompted by a complaint filed by California-based Amphastar Pharmaceuticals, which has been trying to get FDA approval for its generic version of the blood-thinning drug Lovenox for six years. A spokesman for Amphastar confirmed that the company did file an ethics complaint against Woodcock, claiming that her recent collaboration and coauthorship on papers with scientists at Massachusetts-based Momenta Pharmaceuticals is a conflict of interest. Both Amphastar and Momenta are seeking FDA approval for generic versions of Lovenox but have faced lengthy delays because of FDA concerns about adverse immune reactions. Amphastar is asking that Woodcock recuse herself from the approval process for this drug. FDA would neither confirm nor deny it is conducting an investigation, adding that “the agency takes all conflict-of-interest allegations seriously and deals with them appropriately.”