The federal Food & Drug Administration’s top drug approval official is the latest apparatchik to come under fire, the Wall Street Journal reports.
The inspector general of the Dept. of Health and Human Services is investigating a conflict-of-interest allegation against Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research.
The news broke just a day after the FDA’s top devices official, Daniel Schultz, told his soon-to-be-ex-underlings he was stepping down as head of the Center for Devices and Radiological Health.
The case against Woodcock arose after Rancho Cucamonga, Calif.-based Amphastar Pharmaceuticals Inc. filed an ethics complaint accusing her of delaying approval for its generic Lovenox blood thinner in favor of a competitor.
Amphastar accused Woodcock of giving special access to Cambridge, Mass.-based Momenta Pharmaceuticals Inc. during the six-year approval process, which is still under way. Woodcock co-authored a scientific paper with Momenta scientists during their battle for FDA approval of the blood thinners, a relationship Amphastar calls a conflict of interest.
Schultz is leaving under a cloud of similar accusations, after FDA doctors and scientists accused him of having a too-cozy relationship with the medical device industry.
Jeff Shuren will serve as acting CDRH director while FDA looks for a permanent replacement for Schultz.
